[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"UCB Biopharma SRL\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":476},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,44,70,98,125,149,172,195,218,240,264,288,322,352,379,404,426,450],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100445243","phase-3-a-study-to-test-the-efficacy-and-safety-of-staccato-alprazolam-in-study-participants-12-years-of-age-and-older-with-stereotypical-prolonged-seizures-100445243",false,"NCT05077904","A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures","A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Outpatient, Parallel-Group Study to Assess the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures","Inclusion Criteria:\n\n* Participant must be ≥12 years of age at the Baseline\u002FRandomization Visit\n* Participant must have a study caregiver ≥18 years of age at the Screening Visit; the study caregiver(s) must be a relative, partner, friend, or legally authorized representative (LAR) of the participant, or a person who provides daily care to the participant and has a significant personal relationship with the participant; the study caregiver(s) must be able to recognize and observe the participant's seizures\n* Participants with an established diagnosis of focal or generalized epilepsy or combined focal and generalized epilepsy with a documented history of stereotypical episodes of prolonged seizures that includes at least 1 of the following:\n\n  1. Generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum total duration of 5 minutes\n  2. Episodes of a focal seizure with a minimum duration of 3 minutes\n  3. Episodes of a focal seizure or a flurry of myoclonic seizures for at least 90 seconds followed by a generalized\u002Fbilateral tonic-clonic seizure with a minimum total duration of 3 minutes\n* Prior to the Screening Visit, participant has experienced ≥4 stereotypical episodes of prolonged seizures in the past 6 months, and the last 2 stereotypical episodes of prolonged seizures must have occurred within the 3 months prior to the Screening Visit\n* Participant has had a documented brain computerized tomography or magnetic resonance imaging review, performed after diagnosis of epilepsy and within the 5 years prior to the Screening Visit, that confirms the absence of a progressive neurological disorder\n* Participant is receiving a regimen of antiseizure medications (ASMs) that has been stable (ie, no addition or removal of ASM\\[s\\]; dose adjustments are permitted to ASM\\[s\\]; dose adjustments are not permitted for benzodiazepines) for 30 days prior to the Screening Visit\n* Male and female participants:\n\n  1. A male participant must agree to use contraception during the Outpatient Treatment Period and for at least 7 days after IMP administration and refrain from donating sperm during this period\n  2. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:\n\n  i) Not a woman of childbearing potential (WOCBP) OR ii) A WOCBP who agrees to follow the contraceptive guidance during the Outpatient Treatment Period and for at least 30 days after IMP administration\n* Participant is capable of giving signed informed consent (or giving assent, where required), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF), the protocol, and the individualized participant management plan (iPMP). The ICF or a specific assent form, where required, will be signed and dated by minors\n* The participant's study caregiver(s) must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF, the protocol, and the iPMP\n\nExclusion Criteria:\n\n* Participant has a current history of alcohol or drug use disorder, as defined in the Diagnostic and Statistical Manual of Mental Disorders 5, within the previous 1 year\n* Participant has a known hypersensitivity to any components of the IMP or comparable drugs (and\u002For an investigational device) as stated in this protocol or to albuterol (or similar bronchospasm rescue medication if needed to meet country-specific requirements)\n* Participant has a diagnosis of atrial fibrillation or mitral stenosis\n* Participant has a history of convulsive (generalized tonic-clonic) status epilepticus in the 8 weeks prior to the Screening Visit\n* Participant has a history or presence of known nonepileptic seizures which cannot be distinguished from qualifying epileptic seizures\n* Participant has a clinically significant known airway hypersensitivity (eg, bronchospasm to known allergens, such as pollen, animals, or food) and\u002For acute respiratory signs\u002Fsymptoms (eg, shortness of breath, wheezing on lung auscultation)\n* Participant has a clinically significant chronic pulmonary disorder other than mild asthma (eg, chronic obstructive pulmonary disease, restrictive lung diseases \\[including idiopathic pulmonary fibrosis\\]) and\u002For recent history or presence of hemoptysis or pneumothorax\n* Participant has had a positive antigen test for acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and experienced moderate to severe signs\u002Fsymptoms of respiratory distress necessitating hospitalization or outpatient treatment such as ambulatory oxygen, extensive treatment with inhaler medications, and\u002For oral medications for a duration of 4 weeks or more, unless full resolution occurred at least 6 months prior to Screening\n* Participant has experienced a upper respiratory tract infection within 4 weeks or bronchitis\u002Fpneumonia within 3 months before the Screening Visit\n* Participant has a history or presence of acute narrow-angle glaucoma\n* Participant has a condition for which oral alprazolam is contraindicated (eg, myasthenia gravis, severe respiratory insufficiency, and sleep apnea syndrome)\n* Participant has a history or presence of long QT syndrome, a family history of sudden death due to long QT syndrome, or unexplained syncope\n* Chronic use of benzodiazepines for more than 3 days within a period of 7 days will be allowed for approximately 30 % of study participants\n* Participant is taking any drug that is a strong CYP3A4 inhibitor, including azole antifungal agents (ketoconazole and itraconazole) and nefazodone\n* Participant is taking any opioids (eg, fentanyl, oxycodone, morphine) or sedative hypnotics on a chronic basis\n* Participant is taking nonselective beta blockers on a chronic basis\n* Participant is taking pharmacotherapy for an active major psychiatric disorder where major changes in regimen are needed or anticipated during the study\n* Participant has been treated with vagal nerve stimulation (VNS) for less than 6 months or VNS settings have changed within 30 days before the Screening Visit\n* Participant has a clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results, according to the judgment of the Investigator\n* Participant has an oxygen saturation \\\u003C95 % (or less than normal in regions of altitude \\>2500 meters) for greater than 30 seconds during the Screening Visit. In case of an out-of-range result, 1 repeat will be allowed. If the readings are out of range again, the study participant will be excluded\n* Participant has \\>2.0x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \\>1.0xULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome or \\>2.0xULN total bilirubin for liver impairment)\n* Participant has current unstable liver or biliary disease per Investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis\n* Participant has a QT interval corrected for heart rate (QTc) \\>450 msec (males), QTc interval \\>470 msec (females), or QTc interval \\>480 msec (participants with bundle branch block), PR interval ≥220 msec, or any other clinically significant electrocardiogram (ECG) abnormality according to the Investigator i) The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF). It is either machine-read or manually over-read\n* Participant has a positive urine screen for drugs of abuse at the Screening Visit\n* Participant has a blood pressure (BP) or heart rate (HR) outside the following range after 5 minutes rest: systolic BP: 90 mmHg to 150 mmHg; diastolic BP: 4 0mmHg to 95 mmHg; HR: 50 bpm to 100 bpm. In case of an out-of-range result, 1 repeat will be allowed. If the readings are out of range again, the study participant will be excluded","ALL","12 Years",{"count":19,"type":20},350,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.",[26],"Stereotypical Prolonged Seizures",[28,29,30],"Stereotypical prolonged seizures","Phase 3","Staccato alprazolam","RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-01","ACTUAL",{"date":37,"type":35},"2021-12-07",{"date":39,"type":20},"2026-07-31",{"name":41,"class":42},"UCB Biopharma SRL","INDUSTRY",183,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100633809","slc6a1-ndd-prospective-longitudinal-natural-history-study-100633809","NCT07531511","SLC6A1-NDD Prospective Longitudinal Natural History Study","SPIRIT","Inclusion Criteria:\n\n* Patient with a diagnosis of SLC6A1-NDD characterized by epilepsy, global developmental delay, autism spectrum disorder, or intellectual disability, with a documented history of an SLC6A1 mutation, defined as pathogenic or likely pathogenic by the Investigator.\n* Patients should not be older than 17 years at time of assent\u002Fconsent.\n* Patients under the age of 18 years with legal guardians providing informed consent. Assent will be obtained from any patients judged to have sufficient capacity to provide assent at the discretion of the Investigator.\n* Patient and patient's caregiver are willing and able to comply with study requirements (including diary completion and visit schedule).\n\nExclusion Criteria:\n\n* Patients and their caregivers are unable to complete follow-up visits.\n* Patients with a history of an alternate diagnosis for disease, including a genetic cause, which is known to contribute to epilepsy or NDD.\n* Patient is currently receiving an investigational product(s) other than 4-phenylbutyrate or has received an investigational product within 30 days or within \\\u003C5 times the half-life of the investigational product, whichever is longer, prior to the Enrollment Visit.","17 Years",{"count":53,"type":20},60,"OBSERVATIONAL","The overall objective of this prospective longitudinal natural history study is to collect clinical data to characterize and evaluate the natural course of SLC6A1-NDD and assess the feasibility of certain assessments for the purpose of conducting future clinical studies in patients with this disease.",[57,58],"SLC6A1 Neurodevelopmental Disorder (NDD)","Developmental and Epileptic Encephalopathies (DEE)",[60,61],"SLC6A1- NDD","Natural history study","NOT_YET_RECRUITING","2026-06-25",{"date":32,"type":35},{"date":66,"type":20},"2026-07-06",{"date":68,"type":20},"2029-05-25",{"name":41,"class":42},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100563527","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-dapirolizumab-pegol-in-study-participants-with-moderately-to-severely-active-systemic-lupus-erythematosus-100563527","NCT06617325","A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus","PHOENYCS FLY","Inclusion Criteria:\n\n* Study participant must be ≥16 years of age, (≥18 years of age for China), unless restricted by local regulation, at the time of signing the Informed Consent form (ICF)\n* Study participants who have moderate to severe disease activity due to either persisting active systemic lupus erythematosus (SLE) or due to an acute worsening of SLE in the scope of frequent relapsing-remitting SLE despite stable standard of care(SOC) medication defined as:\n\n  a. Diagnosed with SLE at least 24 weeks before the Screening Visit by a qualified physician b. Classified by 2019 SLE European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for SLE c. With serological evidence for SLE at Screening as demonstrated by at least 1 of the following: i) Evidence for anti-dsDNA (defined as evidence for anti-dsDNA antibodies in central laboratory) ii) Either complement C3 \\\u003Clower limit of normal (LLN) OR complement C4 \\\u003CLLN as measured by central laboratory iii) Antinuclear antibodies with a titer of at least 1:80 confirmed by central laboratory in combination with evidence of at least 1 of the following SLE typical autoantibodies:\n  1. Anti-Smith (anti-Sm) antibodies (central laboratory or source verifiable history)\n  2. Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)\u002FAnti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory)\n  3. Historical evidence for anti-dsDNA antibodies\n  4. Anti-ribonucleoprotein (RNP) autoantibodies (central laboratory) d. Moderately to severely active defined as:\n\n     * British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade B in ≥2 organ systems and\u002For a BILAG 2004 Grade A in ≥1 organ systems at Screening and Baseline Visit AND\n     * Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 at the Screening Visit AND\n     * SLEDAI-2K without labs ≥4 at Baseline Visit e. Receiving the following standard of care (SOC) medications at stable dose:\n     * Antimalarial treatment in combination with glucocorticoids and\u002For immunosuppressants or as stand-alone treatment if justified OR\n     * Treatment with glucocorticoids and\u002For immunosuppressants if antimalarial treatment is not appropriate (ie, there is documented intolerance in medical history, documented lack of efficacy, contraindications, or lack of availability)\n\n     Exclusion Criteria:\n* Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition\n* Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies. This includes systemic reactions due to latex allergy\n* Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ (after complete resection \\[eg, curettage, electrodesiccation\\] not later than 4 weeks prior to the Screening Visit \\[V1\\]), basal cell carcinoma, or dermatological squamous cell carcinoma\n* Study participant has a mixed connective tissue disease, scleroderma, and\u002For overlap syndrome of these diseases with SLE\n* Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study\n* Study participant has clinically significant active or latent infection\n* Study participant had a reactivated latent infection (eg, cytomegalovirus, herpes simplex virus, or herpes zoster infection) or opportunistic infection (including but not limited to, pneumocystis, cytomegalovirus, or severe herpes zoster infection) within 12 weeks prior to the first study medication infusion (Visit 2) or is currently receiving suppressive therapy for an opportunistic infection\n* Study participants who have received live\u002Flive attenuated vaccines within 6 weeks prior to the first study medication infusion\n* Study participant has used the prohibited medications within the time frame (Wash-Out Period) listed in the Protocol\n* Study participant has previously been randomized within this study or has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP\n* Study participant has participated in another study of an investigational medicinal product (IMP) within the previous 12 weeks or 5 half-lives of the IMP whatever is longer, or is currently participating in another study of an IMP\n* Study participant has chronic kidney failure stage 4, manifested by estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m2, or serum creatinine \\>2.5 mg\u002FdL, or participant has proteinuria \\>3g\u002Fday, or protein:creatinine ratio \\>340 mg\u002Fmmol at the Screening Visit","16 Years",{"count":80,"type":20},450,[23],"The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.",[84],"Systemic Lupus Erythematosus",[86,87,88,89],"Systemic lupus erythematosus","Dapirolizumab pegol","SLE","DZP",{"date":91,"type":35},"2026-06-26",{"date":93,"type":35},"2024-11-21",{"date":95,"type":20},"2028-05-31",{"name":41,"class":42},230,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"100615240","phase-1-a-study-to-learn-if-bimekizumab-given-in-different-ways-is-safe-and-moves-similarly-throughout-the-body-over-time-in-adults-100615240","NCT07290036","A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults","An Open-label, Randomized, Parallel-group, Noninferiority Study to Evaluate the Pharmacokinetics of Bimekizumab Administered Intravenously or as a Subcutaneous Injection in Participants With Active Psoriatic Arthritis and\u002For Active Axial Spondyloarthritis","Inclusion Criteria:\n\n1. Be 18+ years old and legally able to consent\n2. Have active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA), suitable for bimekizumab treatment\n3. Weigh between 45-100 kg (females) or 50-100 kg (males).\n4. Be biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve or have stopped bDMARDs ≥3 months or 5 half-lives ago\n\nExclusion Criteria:\n\n1. Serious organ system disorders (e.g., heart, liver, kidney, gastrointestinal, neuro)\n2. Severe psychiatric issues or substance abuse in the past year\n3. Recent or chronic infections, including tuberculosis (TB) or nontuberculous mycobacterium (NTMB)\n4. Other inflammatory diseases (e.g., rheumatoid arthritis (RA), lupus, inflammatory bowel disease (IBD))\n5. Recent live vaccines (within 8 weeks) or Bacillus Calmette-Guerin (BCG) (within 1 year)\n6. Recent use of glucagon-like peptide-1 (GLP-1) agonists (within 28 weeks)","18 Years",{"count":107,"type":20},392,[109],"PHASE1","To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.",[112,113],"Psoriatic Arthritis","Axial Spondyloarthritis",[115],"Bimekizumab, BKZ, Phase 1B","2026-06-18",{"date":118,"type":35},"2026-06-22",{"date":120,"type":35},"2025-12-10",{"date":122,"type":20},"2028-09-14",{"name":41,"class":42},62,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},"100614289","phase-2-a-dose-ranging-study-to-evaluate-the-efficacy-safety-pharmacokinetics-and-pharmacodynamics-of-galvokimig-in-adult-study-participants-with-atopic-dermatitis-100614289","NCT07277660","A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Moderate to Severe Atopic Dermatitis","Inclusion Criteria:\n\n* Participant must be aged greater than or equal (≥)18 years at the time of signing the informed consent\n* Participant has chronic atopic dermatitis (AtD) (according to American Academy of Dermatology Consensus Criteria) that has been present for at least ≥1 year prior to initiating the study (ie, signing of the informed consent form \\[ICF\\]) and with:\n\n  1. validated Investigator Global Assessment (vIGA) score ≥3 at Screening and Baseline\n  2. Eczema Area and Severity Index (EASI) score ≥16 at both Screening and Baseline\n  3. Peak Pruritus Numerical Rating Scale (PP-NRS) score of ≥4 at both Screening and Baseline\n  4. ≥10% body surface area (BSA) of AtD involvement at both Screening and Baseline\n  5. Documented recent history (within 6 months prior to Screening) of inadequate response to treatment with topical medications, or study participants for whom topical treatments are otherwise medically inadvisable (eg, due to important side effects or safety risks) and who are candidates for systemic therapy\n\nExclusion Criteria:\n\n* Participant has any history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, or electrocardiogram (ECG) signal that, in the opinion of the investigator, could constitute a risk when taking the study intervention; or interfere with the interpretation of data and could jeopardize or would compromise the study participant's ability to participate in this study\n* Active dermatologic conditions that may confound the diagnosis of AtD or would interfere with assessment of treatment, such as but not limited to scabies, seborrheic dermatitis, cutaneous lymphoma, ichthyosis, psoriasis, active allergic or irritant contact dermatitis\n* Presence or family history (first degree) of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis)\n* History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline (including herpes zoster) as judged by the investigator\n* Participants are not permitted to enroll into the study if they meet tuberculosis (TB) exclusion criteria\n* Previous treatment with galvokimig\n* Participant has relevant safety events to one or more interleukin (IL)-13 biologic response modifiers (ie, dupilumab, tralokinumab and lebrikizumab) that resulted in discontinuation and change of treatment\n* All systemic therapies (other than biologics), topical therapies and other treatments for AtD must be discontinued at least 4 weeks prior to Baseline\n* Treatment with biologic agents must discontinued at least 3 months prior to baseline",{"count":133,"type":20},160,[135],"PHASE2","The purpose of the study is to evaluate the dose-response relationship of galvokimig compared with placebo in study participants with moderate-to-severe atopic dermatitis (AtD).",[138],"Atopic Dermatitis",[138,140,141],"Galvokimig,","UCB9741",{"date":118,"type":35},{"date":144,"type":35},"2025-12-29",{"date":146,"type":20},"2028-03-06",{"name":41,"class":42},66,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":159,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100609810","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-bimekizumab-in-study-participants-with-palmoplantar-pustulosis-100609810","NCT07219420","A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study With Open-Label Extension to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis","BeSeen","Inclusion Criteria:\n\n* At least 18 years of age inclusive, at the time of signing the informed consent form (ICF)\n* Have a palmoplantar pustulosis (PPP) diagnosis for at least 24 weeks prior to the Screening Visit\n* Have PPPASI ≥12 at the Screening Visit and Baseline Visit\n* Have PPP-IGA ≥3 at the Screening Visit and Baseline Visit\n* Have pustules on the palms of the hands and\u002For soles of the feet at the Screening Visit and Baseline Visit, defined as pustule severity ≥2 and having more than 5 active pustules\n* Participant must be a candidate for systemic therapy or phototherapy\n\nExclusion Criteria:\n\n* Has PPP symptoms which improve significantly between the Screening Visit and Baseline Visit, defined as a reduction in the PPPASI score\n* Has the following: palmoplantar PSO (plaque PSO on palms\u002Fsoles), guttate PSO, erythrodermic PSO (EP), generalized pustular PSO (GPP), Acrodermatitis continua of Hallopeau (ACH), atopic dermatitis, dyshidrotic eczema or chronic hand eczema.\n* Has drug-induced PSO (eg, first onset or current exacerbation due to beta blockers, calcium channel inhibitors, lithium, or tumor necrosis factor \\[TNF\\] inhibitor) or drug-induced pustular PSO (eg, acute generalized exanthematous pustulosis, acute localized exanthematous pustulosis)\n* Has cutaneous lesions that may interfere with the evaluation of the affected area and\u002For evaluation of the severity of PPP\n* Is taking or has taken prohibited or restricted medications without meeting the mandatory discontinuation or stability period relative to the Baseline Visit\n* Is taking or has ever taken an interleukin (IL)-17A\u002FIL-17F inhibitor, including bimekizumab, or has participated in a bimekizumab investigational study",{"count":158,"type":20},320,[23],"The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP).",[162],"Palmoplantar Pustulosis",[164],"Bimekizumab, PPP",{"date":118,"type":35},{"date":167,"type":35},"2025-11-14",{"date":169,"type":20},"2029-11-22",{"name":41,"class":42},77,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":179,"maxAge":51,"enrollmentInfo":180,"targetDuration":4,"studyType":21,"phases":182,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":5},"100586935","phase-3-a-study-to-assess-the-pharmacokinetics-and-safety-of-bimekizumab-in-children-and-adolescents-with-moderate-to-severe-hidradenitis-suppurativa-100586935","NCT06921850","A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa","A Multicenter, Open-Label Study to Assess The Pharmacokinetics And Safety of Bimekizumab in Pubertal Children And Adolescents With Moderate to Severe Hidradenitis Suppurativa","Inclusion Criteria:\n\n* Study participant must be 12 to \\\u003C18 years of age at the time of informed consent\u002Fassent, at Tanner stage 2 or more, for the first 8 participants only, followed by also including participants ≥9 to \\\u003C18 years of age at Tanner stage 2 or more.\n* Study participant must have a diagnosis of HS for at least 6 months prior to the Baseline Visit.\n* Study participant must have moderate to severe HS, defined as a total of ≥5 inflammatory lesions (ie, the sum of abscesses and inflammatory nodules), as assessed at both the Screening and Baseline Visits.\n* Study participant must have HS lesions present in at least 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or III, as assessed at both the Screening and Baseline Visits.\n* Study participant must have had a history of inadequate response to a course of a systemic antibiotic for treatment of HS\n* Study participant must weigh ≥30kg at the Screening Visit.\n\nExclusion Criteria:\n\n* Study participant has a draining tunnel count of \\>20 at either the Screening or Baseline Visits.\n* Study participant has experienced primary failure (no response within 12 weeks) to 1 or more IL 17 biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) OR primary failure to more than 1 biologic response modifier other than an IL-17 biologic response modifier.\n* Study participant has previously participated in this study or has received previous therapy with bimekizumab.\n* Study participant has a history of IBD or symptoms suggestive of IBD.\n* History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated\n* Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections)\n* Study participant has received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments\n* Study participant has the presence of active suicidal ideation, or positive suicide behavior,\n* Study participant diagnosed with severe depression in the past 6 months prior to the Screening Visit.\n* Study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study.","9 Years",{"count":181,"type":20},40,[23],"The purpose of the study is to assess the PK of bimekizumab following subcutaneous (sc) administration in study participants with moderate to severe hidradenitis suppurativa (HS)",[185],"Hidradenitis Suppurativa",[187,188,185],"Bimekizumab","HS",{"date":118,"type":35},{"date":191,"type":35},"2025-04-07",{"date":193,"type":20},"2029-03-06",{"name":41,"class":42},{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":202,"maxAge":105,"enrollmentInfo":203,"targetDuration":4,"studyType":21,"phases":204,"briefSummary":205,"conditions":206,"keywords":209,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},"100567437","phase-3-an-open-label-study-to-evaluate-the-pharmacokinetics-and-safety-of-bimekizumab-in-pediatric-study-participants-with-active-juvenile-idiopathic-arthritis-subtypes-enthesitis-related-arthritis-including-juvenile-onset-ankylosing-spondylitis-and-juvenile-psoriatic-arthritis-100567437","NCT06668181","An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis","Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-Related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis","Inclusion Criteria:\n\n* Study participant must be 2 to \\\u003C18 years of age inclusive, at the Baseline Visit.\n* Study participants who have confirmed diagnosis of enthesitis-related arthritis (ERA; including juvenile-onset ankylosing spondylitis (JAS)) and\u002For juvenile psoriatic arthritis (JPsA) according to the juvenile-International League of Associations for Rheumatology (JIA-ILAR) classification criteria of at least 3 months duration prior to the Screening Visit.\n* Study participants who have active disease (ERA \\[including JAS\\] and\u002For JPsA) defined as having at least 3 active joints, each of which needs to be included in the joints assessed in the JADAS27, and for ERA at least 1 site of enthesitis at Baseline or documented by history.\n* Study participants with inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drug (NSAID).\n* Study participants taking concomitant methotrexate or sulfasalazine are allowed to continue the medication if it has been used for the past 12 weeks with a stable dose for the 4 weeks prior to Baseline, with no change in dose for the first 16 weeks of treatment foreseen. (Note: prior or concomitant use of methotrexate or sulfasalazine is NOT required for study participation.)\n* Study participants with no concomitant use of second line agents such as disease-modifying and\u002For immunosuppressive drugs with the exception of methotrexate or sulfasalazine.\n* Body weight of ≥10kg.\n* Male and female.\n* A female study participant will be eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:\n\n  1. Not a woman of childbearing potential (WOCBP) OR\n  2. A WOCBP who agrees to follow the contraceptive guidance during the Initial Treatment Period, the Open-label Extension (OLE) Period, and for at least 20 weeks after the final dose of investigational medicinal product (IMP; ie, the Safety Follow-up (SFU) Period)\n* Capable of giving\u002Fhaving parent(s) or legal representative provide signed informed consent\u002Fassent (where appropriate), which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and assent and in this protocol.\n\nExclusion Criteria:\n\n* Study participants fulfilling any International League of Associations for Rheumatology (ILAR) diagnostic juvenile idiopathic arthritis (JIA) category other than enthesitis-related arthritis (ERA; including juvenile-onset ankylosing spondylitis (JAS)) and\u002For juvenile psoriatic arthritis (JPsA).\n* Study participant has history of inflammatory bowel disease (IBD) or signs\u002Fsymptoms suggestive of IBD.\n* Study participant has active uncontrolled uveitis.\n* Study participant has history of active tuberculosis (TB) unless successfully treated, latent TB unless prophylactically treated.\n* Study participant has had major surgery (including joint surgery) within the 3 months prior to the Baseline Visit or has planned major surgery within 6 months after entering the study.\n* Study participant has laboratory abnormalities at Screening defined in the Protocol.\n* Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections).\n* Study participant has received drugs listed in the protocol outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments.\n* Study participant had previous therapy with bimekizumab or prior treatment with other IL-17 biologic response modifier.\n* Study participant had prior treatment with more than one biologic response modifier (other than an IL-17).\n* Presence of active suicidal ideation, or positive suicide behavior.\n* Study participant has been diagnosed with severe depression in the past 6 months.","2 Years",{"count":181,"type":20},[23],"The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.",[207,208],"Enthesitis-related Arthritis","Juvenile Psoriatic Arthritis",[210,187],"Arthritis",{"date":118,"type":35},{"date":213,"type":35},"2025-03-11",{"date":215,"type":20},"2030-07-31",{"name":41,"class":42},23,{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":16,"minAge":202,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":21,"phases":227,"briefSummary":228,"conditions":229,"keywords":232,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":217},"100540321","phase-3-a-study-to-test-the-long-term-safety-and-tolerability-of-brivaracetam-in-study-participants-with-childhood-absence-epilepsy-or-juvenile-absence-epilepsy-100540321","NCT06315322","A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy","A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE LONG-TERM SAFETY AND TOLERABILITY OF BRIVARACETAM IN STUDY PARTICIPANTS WITH CHILDHOOD ABSENCE EPILEPSY OR JUVENILE ABSENCE EPILEPSY","Inclusion Criteria:\n\n* Participants who previously participated in EP0132 (NCT05109234) and\u002For N01269 (NCT04666610) and qualify for entry into EP0224 as per the EP0132 or N01269 protocol with a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE)\n* Participants for whom a reasonable benefit from long-term administration of Brivaracetam (BRV) is expected in the opinion of the Investigator\n* Male and female A male participant must agree to use contraception during the treatment period and for at least 2 days after the final dose of investigational medicinal product (IMP) and refrain from donating sperm during this period.\n\nA female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:\n\n◦ Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the final dose of IMP.\n\n\\- Capable of and provides informed consent\u002Fassent, and the participant's parent\u002Flegal representative\u002Fcaregiver provides signed informed consent for minor participants, which includes compliance with the requirements and restrictions listed in the Informed Consent form (ICF)\u002FAssent form and in this protocol\n\nExclusion Criteria:\n\n* Participant has a history or presence of paroxysmal nonepileptic seizures\n* Participant has severe medical, neurological, or psychiatric disorders or laboratory values which could, at the discretion of the Investigator, affect safe participation in the study or would preclude appropriate study participation\n* Participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment\n* Participant has active suicidal ideation prior to study entry as indicated by a positive response (\"Yes\") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) (for participants 6 years of age or older) or clinical judgment (for participants younger than 6 years of age). The participant should be referred immediately to a Mental Healthcare Professional\n* Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study\n* Participant has known fructose intolerance or a known hypersensitivity to any components of BRV or excipients or a drug with similar chemical structure\n* Concomitant use of carbamazepine, felbamate, gabapentin, oxcarbazepine, phenobarbital, phenytoin, tiagabine, or vigabatrin\n* Participant is receiving any investigational drugs or using any experimental devices in addition to BRV\n* Participant meets a mandatory withdrawal criterion for N01269 or EP0132 or is experiencing an ongoing Serious adverse event (SAE)\n* Participant has poor compliance with the visit schedule or IMP intake in the preceding study in the opinion of the Investigator",{"count":226,"type":20},120,[23],"The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy.",[230,231],"Childhood Absence Epilepsy","Juvenile Absence Epilepsy",[230,231,29,233],"Brivaracetam",{"date":118,"type":35},{"date":236,"type":35},"2024-07-10",{"date":238,"type":20},"2030-03-01",{"name":41,"class":42},{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":21,"phases":249,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":263},"100628583","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-rozanolixizumab-in-adult-participants-with-ocular-myasthenia-gravis-100628583","NCT07463521","A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis","MyVision","Inclusion Criteria:\n\n* Participant must be a minimum of 18 years of age inclusive at the time of signing the informed consent form (ICF)\n* Participant has Myasthenia Gravis Foundation of America (MGFA) Class I with any ocular weakness at Screening through Baseline. The participant may have weakness in muscles of eye (ie, extraocular muscles that move the eyeball, including the medial rectus, lateral rectus, superior rectus, inferior rectus, superior oblique, and inferior oblique, orbicularis oculi muscles, and levator palpebrae superioris) but must have normal strength in all other facial, bulbar, and limb muscles.\n* Study participant has been diagnosed with Ocular Myasthenia Gravis (oMG) with consistent ocular clinical features at Screening and supported by:\n* Documented presence of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK), OR\n* Documented absence of autoantibodies against AChR or MuSK; in this case, documented abnormal repetitive nerve stimulation (RNS) or single fiber electromyography (SFEMG) (as defined in the adjudication manual) and at least 1 of the following should be met:\n\n  * Documented positive ice test (Ptosis recovers with the ice test \\[applied 2 minutes (min) to the ptotic lid\\] with \\>2mm improvement)\n  * History of positive edrophonium chloride (Tensilon) test (or equivalent tests used to establish oMG diagnostic as per current practice)\n  * Demonstrated objective improvement in oMG signs with acetylcholinesterase inhibitor (AChEIs), plasma exchange (PLEX), intravenous immunoglobulin (IVIg), subcutaneous immunoglobulin (SCIg) or corticosteroids (CSs)\n* Participant has an Myasthenia Gravis Impairment Index (MGII) ocular score (Patient-Reported Outcome (PRO) part) ≥6 with at least 2 ocular items with a score of ≥2 at both Screening and Baseline visits.\n* Participant reported ocular symptom(s) onset \\\u003C3 years before Screening or ≥3 years provided they have demonstrated response (ie, improvement in ptosis or diploplia) to treatment (IVIg, PLEX, SCIg, pyridostigmine, and\u002For CSs) in the past year.\n* Participant has no pupillary abnormality except those resulting from prior localized eye disease or surgical intervention.\n* Participant who:\n\n  * is currently receiving background treatment for oMG symptoms at the time of Screening and has been receiving treatment for oMG with a stable dose for at least 30 days prior to Screening, OR\n  * is not receiving any background treatment at the time of Screening\n* Participant has a body weight ≥35kg at Baseline.\n\nExclusion Criteria:\n\n* Participant has any clinically significant medical or psychiatric condition (including an alcohol or drug use disorder), recent major surgery (including thymectomy \\[within 3 months of Screening\\], solid organ, stem cell or marrow transplant), planned major surgery (including thymectomy) during study participation, and\u002For significant laboratory abnormality that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study.\n* Participant has been diagnosed with other diseases that lead to eyelid dropping, peripheral muscle weakness, or diplopia, including other autoimmune diseases that would interfere with an accurate assessment of the oMG clinical symptoms or other neurological diseases, such as congenital myasthenic syndromes, mitochondrial diseases, and muscular dystrophies.\n* Participant has a known hypersensitivity to other anti-Fc receptor (FcRn) medications, to any components of the study medication (including the excipient polysorbate 80) or has a known history of hyperprolinemia, since L-proline is a constituent of the rozanolixizumab formulation.\n* Participant has active neoplastic disease or has received treatment for neoplastic disease within 5 years of study entry (except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the uterine cervix, carcinoma in situ of the breast, or incidental histological findings of prostate cancer \\[Tumor, Node, Metastasis (TNM) stage T1a or T1b\\] that has been definitely treated with standard of care approaches).\n* Participant has a clinically relevant active infection (eg, tuberculosis (TB) infection) or a history of serious infection (resulting in hospitalization or requiring intravenous (iv) antibiotic treatment) within 6 weeks before the Baseline Visit.\n* Participant has renal impairment, defined as glomerular filtration rate less than 30milliliter\u002Fmin\u002F1.73m2 at Screening.\n* Participant has been previously treated with FcRn inhibitors.\n* Participant has been treated with any of the immunosuppressive medications, biologics, or other therapies, in the specified prohibitive timeframe.",{"count":226,"type":20},[23],"The purpose of the study is to demonstrate the efficacy, safety and tolerability of rozanolixizumab compared with placebo in the treatment of adult study participants with Ocular Myasthenia Gravis.",[252],"Ocular Myasthenia Gravis",[252,29,254],"rozanolixizumab","2026-06-12",{"date":257,"type":35},"2026-06-16",{"date":259,"type":35},"2026-05-27",{"date":261,"type":20},"2029-01-22",{"name":41,"class":42},2,{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":21,"phases":272,"briefSummary":274,"conditions":275,"keywords":277,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":287},"100611898","phase-4-phase-4-study-evaluating-efficacy-and-safety-of-rozanolixizumab-in-adult-chinese-participants-with-generalized-myasthenia-gravis-100611898","NCT07246564","Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis","An Open-label, Prospective, Single-arm Study Assessing the Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis","Inclusion Criteria:\n\n* Study participant must be ≥18 years of age at the time of signing the informed consent form (ICF)\n* Study participant has documented diagnosis of generalized myasthenia gravis (gMG) at the Screening Visit based on study participant's history and supported by previous evaluation\n* Study participant has a confirmed positive record of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) documented in the medical history at the Screening Visit\n* Study participant has Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II to IV at Screening Visit.\n* Study participant with a myasthenia gravis-activities of daily living (MG-ADL) score of at least 3 points from non-ocular symptoms and a quantitative myasthenia gravis (QMG) score of at least 11 at the Screening and Baseline visits in the first Treatment Cycle.\n* Study participant is considered for additional treatment by the investigator\n* Body weight ≥35kg at the Screening Visit\n\nExclusion Criteria:\n\n* Study participant has a known hypersensitivity to any components of the study drug or any other anti-neonatal Fc receptor (anti-FcRn) medications\n* Study participant has a clinically important active infection including unresolved or not adequately treated infection in the opinion of the investigator\n* Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current\u002Fhistory of nontuberculous mycobacterial infection (NTMBI)\n* Study participant has previously received rozanolixizumab drug product\n* Study participant has received any vaccine in the 4 weeks prior to the initiation of rozanolixizumab treatment or intends to receive any vaccine within 2 weeks after the last infusion of rozanolixizumab. Note: For participants that are on rozanolixizumab treatment, vaccination with live or live-attenuated vaccines is not recommended. During the whole study period, all other vaccines should take place at least 2 weeks after the last infusion of a Treatment Cycle and 4 weeks before initiating the next cycle\n* Study participant has been treated with prohibited immunosuppressants, biologics, and other therapies within the timeframe shorter than the treatment-free period\n* Study participant with severe (defined as Grade 3 on the MG-ADL scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis. Note: Impending Crisis is defined as bulbar or respiratory symptoms of a patient who significantly worsens in a short time (≤2 weeks) and meet MGFA IVb or score 3 in one QMG bulbar muscle item, or score 2 in respiratory muscle item, or bulbar+respiratory items score ≥4",{"count":181,"type":20},[273],"PHASE4","The purpose of the study is to assess the clinical efficacy of rozanolixizumab in adult Chinese participants with generalized myasthenia gravis (gMG) in the first Treatment Cycle.",[276],"Myasthenia Gravis",[278],"Rozanolixizumabg, gMG","2026-05-21",{"date":281,"type":35},"2026-05-22",{"date":283,"type":35},"2025-12-01",{"date":285,"type":20},"2027-10-15",{"name":41,"class":42},12,{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":16,"minAge":296,"maxAge":51,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":299,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":321},"100548788","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-bimekizumab-compared-to-ustekinumab-in-children-and-adolescents-from-6-years-to-less-than-18-years-of-age-with-moderate-to-severe-plaque-psoriasis-100548788","NCT06425549","A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis","A Multicenter, Randomized, Parallel-Group, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis","BE TOGETHER","Inclusion Criteria:\n\n* Study participant must be 6 to \\\u003C18 years of age, inclusive, at the time of signing the informed consent\u002Fassent according to local regulation\n* Study participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit\n* Study participant meets the following at both the Screening and Baseline Visits:\n\n  1. Body surface area (BSA) affected by PSO ≥10%\n  2. . Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4)\n  3. . Psoriasis Area and Severity Index (PASI) score ≥12 OR\n\nPASI score ≥10 plus at least 1 of the following:\n\ni) Clinically relevant facial involvement ii) Clinically relevant genital involvement iii) Clinically relevant hand and foot involvement\n\n* Study participant is a candidate for systemic PSO therapy and\u002For photo\u002Fchemotherapy and for treatment with ustekinumab per labeling\n* Study participant has body weight ≥15 kg and body mass index for age percentile of ≥5 at Screening\n\nExclusion Criteria:\n\n* Primary failure (no response within 12 weeks) to 1 or more interleukin-17 (IL-17) biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) OR more than 1 biologic response modifier other than an IL-17\n* Study participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO\n* Study participant has a history of inflammatory bowel disease (IBD) or symptoms suggestive of IBD\n* History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated\n* Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections)\n* Study participant has previously received bimekizumab\n* Study participant has previously received ustekinumab\n* Study participant has received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments\n* Study participant has the presence of active suicidal ideation, or positive suicide behavior\n* Study participant diagnosed with severe depression in the past 6 months (prior to Screening) should be excluded\n* Study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study","6 Years",{"count":298,"type":20},168,[23],"The primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to \\\u003C18 years of age with moderate to severe plaque psoriasis (PSO).",[302],"Moderate to Severe Plaque Psoriasis",[304,305,306,307,308,309,310,311,312,313,314],"bimekizumab","BKZ","ustekinumab","paediatric study participants","children","adolescents","Psoriasis","PSO","Plaque Psoriasis","Paediatric Psoriasis","Pediatric Psoriasis",{"date":281,"type":35},{"date":317,"type":35},"2024-06-25",{"date":319,"type":20},"2030-11-08",{"name":41,"class":42},50,{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":330,"targetDuration":4,"studyType":21,"phases":332,"briefSummary":333,"conditions":334,"keywords":336,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":351},"100520391","phase-2-a-study-to-evaluate-subcutaneous-zilucoplan-in-pediatric-participants-with-generalized-myasthenia-gravis-100520391","NCT06055959","A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis","A Multicenter Open-Label, Uncontrolled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Activity of Zilucoplan in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Acetylcholine Receptor Antibody Positive Generalized Myasthenia Gravis","ziMyG","Inclusion Criteria:\n\nUnited States of America (USA) specific inclusion criterion:\n\n\\- Participant must be 12 to \\\u003C18 years of age at the time of signing the Informed consent\u002Fassent according to local regulation\n\nRest of world (ROW) specific inclusion criterion:\n\n\\- Participant must be 2 to \\\u003C18 years of age at the time of signing the Informed consent\u002Fassent according to local regulation\n\nGlobal inclusion criteria:\n\n* Participant has a diagnosis of generalized myasthenia gravis (gMG) confirmed by a prior positive serologic test result to acetylcholine receptor (AChR) prior to Screening\n* Participant meets the criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II to IV at Screening\n* Participants with gMG, including:\n* An MG-activities of daily living (MG-ADL) total score of 6 or more in adolescents from 12 years to \\\u003C18 years of age at Screening\n* Documented weakness in at least 1 limb, neck, or bulbar muscle in children from 2 years to \\\u003C12 years of age at Screening (does not apply to US)\n* Documented vaccination against meningococcal infections within 3 years prior to study start. If not fully vaccinated, participants must receive appropriate prophylactic antibiotic treatment until at least 2 weeks after the initial dose of vaccine(s)\n\nExclusion Criteria:\n\n* Participant has known positive serology for muscle-specific kinase\n* Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study\n* Participant has had a thymectomy within 6 months prior to Baseline\n* Participant has minimal Manifestation Status of MG based on the clinical judgement of the Investigator\n* Current or recent systemic infection within 2 weeks prior to Baseline or infection requiring intravenous antibiotics within 4 weeks prior to Baseline",{"count":331,"type":20},8,[135,23],"The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, safety, tolerability, immunogenicity and activity of zilucoplan (ZLP) in pediatric study participants with generalized myasthenia gravis (gMG).",[335],"Generalized Myasthenia Gravis",[337,338,339,340,341,342],"RA101495","gMG","generalized myasthenia gravis","zilucoplan","pediatric","MG0014","2026-05-07",{"date":345,"type":35},"2026-05-08",{"date":347,"type":35},"2024-10-16",{"date":349,"type":20},"2026-12-25",{"name":41,"class":42},9,{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":360,"minAge":105,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":21,"phases":363,"briefSummary":364,"conditions":365,"keywords":366,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":287},"100584350","phase-1-a-study-to-assess-the-concentration-of-bimekizumab-in-mature-breast-milk-from-mothers-receiving-treatment-with-bimzelx-bimekizumab-100584350","NCT06888193","A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)","A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)","BE CARING","Inclusion Criteria:\n\n* Study participant must be at least 18 years of age at the time of signing the informed consent.\n* Study participant is being treated with commercial bimekizumab per locally approved prescribing information and in accordance with her treating physician.\n* Study participant is breastfeeding and intends to breastfeed throughout the Sampling Period.\n* The decision to treat with bimekizumab and to breastfeed is made independently from and prior to the study participant consenting to participate in the study.\n* Study participant must be on bimekizumab treatment for at least 12 weeks after delivery and since starting\u002Frestarting\u002Fcontinuing bimekizumab prior to sampling (prior to start of the Sampling Period).\n* A female study participant is eligible to participate if she is not pregnant and does not plan to become pregnant during the study.\n\nExclusion Criteria:\n\n* Study participant has any medical, obstetrical, or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study.\n* The infant has any abnormality noted on physical examination or medical history that, in the opinion of the Investigator, may jeopardize or compromise study participation.\n* Study participant has a history of chronic alcohol or drug abuse within the previous last year.\n* Study participant has history of breast implants, breast augmentation, or breast reduction surgery.\n* Study participant plans a surgical intervention during the Screening Period and Sampling Period or anticipates having surgery while participating in the Sampling Period (does not apply to tubal ligation).\n* Study participant or her infant has participated in another study of an investigational medicinal product (IMP) (and\u002For an investigational device) within the previous 6 months or is currently participating in another study of an IMP (and\u002For an investigational device), unless the study is UCB PS0036 or a bimekizumab registry study.\n* Study participant or her infant has previously participated (ie, entered the sampling period) in this study.","FEMALE",{"count":362,"type":20},20,[109],"Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.",[302,112,113,185],[187,367,368,311,188,369,370],"Breastfeeding mothers","Bimzelx®","AxSpa","PsA","2026-04-30",{"date":373,"type":35},"2026-05-01",{"date":375,"type":35},"2025-11-05",{"date":377,"type":20},"2027-05-03",{"name":41,"class":42},{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":386,"sex":360,"minAge":105,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":21,"phases":389,"briefSummary":390,"conditions":391,"keywords":393,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":263},"100590002","phase-1-a-study-to-assess-zilucoplan-concentration-in-breast-milk-of-healthy-lactating-women-100590002","NCT06961747","A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Women","An Open-Label, Repeated-Dose Assessment of Zilucoplan Concentration in Breast Milk of Healthy Lactating Women","Inclusion Criteria:\n\n* Study participant must be minimum 18 years at the time of signing the Informed consent form (ICF)\n* Study participant is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring\n* Study participant is lactating and will be at least 6 weeks postpartum on Day 1 of the study\n* Study participant has already planned, prior to having knowledge of this study, to cease breast milk feeding (by any means) in relation to her current period of lactation\n* Study participant agrees to cease breast milk feeding by Day 1 of the study and to not resume breast milk feeding (by any means and of any infant) or donate breast milk following study end for the remainder of her current period of lactation\n* Study participant is up to date with vaccinations against meningococcal bacteria (serogroups A, C, W, Y, and B) at least 2 weeks before the first administration of study medication according to the current (at the time of study participant consent) Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccinations in patients receiving a complement inhibitor\n* Study participant is capable of giving signed informed consent\n\nExclusion Criteria:\n\n* Study participant has a history or presence of\u002Fsignificant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study medication; or interfering with the interpretation of data\n* Study participant has any medical, obstetrical, or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study\n* Study participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) \\>1.0x upper limit of normal (ULN). Tests that result in ALT, AST, or ALP up to 25 percentage (%) above the exclusion limit may be repeated once for confirmation. This includes rescreening. If the repeat values are below the ULN, the study participant will be considered to not meet the exclusion criteria\n* Study participant has bilirubin \\>1.0xULN (isolated bilirubin \\\u003C1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C35%). For participants with a Baseline result \\>ULN for total bilirubin, a Baseline diagnosis and\u002For the cause of any clinically meaningful elevation must be understood and recorded in the eCRF\n* Study participant has a history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years\n* Study participant has current or recent systemic infection within 2 weeks before the first administration of study medication or infection requiring intravenous antibiotics within 4 weeks before the first administration of study medication. Note: Study participants with mastitis at Screening that does not meet the criteria for clinically significant infection may be rescreened after the infection is completely resolved\n* Study participant has a prior history of meningococcal disease\n* Study participant has presence of hepatitis B surface antigen at Screening or within 3 months prior to dosing\n* Study participant has a positive hepatitis C antibody test result at Screening or within 3 months prior to starting study medication\n* Study participant has a positive hepatitis C RNA test result at Screening or within 3 months prior to first dose of study medication\n* Study participant has a positive prestudy drug and\u002For alcohol screen\n* Study participant has a positive human immunodeficiency virus antibody test at the Screening Visit\n* Study participant has a positive syphilis test at the Screening Visit",true,{"count":388,"type":20},15,[109],"The purpose of this study is to assess the steady state (SS) concentrations of zilucoplan (ZLP) and its major metabolites in mature breast milk of healthy study participants following injection of repeated once-daily doses of ZLP.",[392],"Healthy Participants",[394,395,340,337],"Phase 1","Healthy lactating women","2026-03-19",{"date":398,"type":35},"2026-03-24",{"date":400,"type":35},"2025-07-09",{"date":402,"type":20},"2027-03-23",{"name":41,"class":42},{"id":405,"slug":406,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":21,"phases":413,"briefSummary":414,"conditions":415,"keywords":416,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":4},"100628718","phase-3-a-study-to-evaluate-the-long-term-safety-and-efficacy-of-rozanolixizumab-in-adult-participants-with-ocular-myasthenia-gravis-100628718","NCT07465289","A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis","A Phase 3, Open-Label, Extension Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis","Inclusion Criteria:\n\n* Participant must be a minimum of 18 years of age inclusive at the time of signing the informed consent form (ICF)\n* Participant must have received at least 1 dose of investigational medicinal product (IMP) (rozanolixizumab or placebo) in MG0038\n* Participant for whom the investigator considers a favorable benefit\u002Frisk for participation\n* Participant who, alone or with assistance of the caregiver, is considered reliable and capable of adhering to the protocol visit schedule or medication intake according to the judgement of the investigator\n* Male or female\n* A female participant is eligible to participate if she is not, not breastfeeding (including pumping breastmilk to feed a child), and at least 1 of the following conditions applies:\n\n  * Not a woman of childbearing potential (WOCBP)\n  * OR\n  * A WOCBP who agrees to follow the contraceptive guidance for the entire study period\n* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol\n\nExclusion Criteria:\n\n* Participant meets any of the withdrawal criteria defined in MG0038\n* Participant has a clinically relevant active infection (resulting in hospitalization or requiring intravenous (IV) antibiotic treatment) within 6 weeks before study entry.\n* Participant intends to have a live vaccination during the study or within 8 weeks following the final dose of rozanolixizumab\n* Participant has been administered with the prohibited immunosuppressive medications, biologics, or other therapies\n* Participant has planned use of prohibited medications",{"count":412,"type":20},100,[23],"The purpose of the study is to assess the long-term safety and efficacy of rozanolixizumab in adult study participants with ocular myasthenia gravis.",[252],[29,417,254],"oMG","2026-03-06",{"date":420,"type":35},"2026-03-11",{"date":422,"type":20},"2026-07-27",{"date":424,"type":20},"2031-01-23",{"name":41,"class":42},{"id":427,"slug":428,"hasResults":11,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":386,"sex":16,"minAge":105,"maxAge":433,"enrollmentInfo":434,"targetDuration":4,"studyType":21,"phases":436,"briefSummary":437,"conditions":438,"keywords":439,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":449},"100614983","phase-1-a-study-to-investigate-the-safety-tolerability-and-pharmacokinetics-of-ucb5285-in-healthy-study-participants-100614983","NCT07286682","A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB5285 in Healthy Study Participants","A Phase 1, Randomized, Placebo-Controlled Single Ascending Dose Participant- and Investigator-Blind Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB5285 in Healthy Study Participants","Inclusion Criteria:\n\n* For study participants of Japanese origin: study participant who is born in Japan and of Japanese descent as evidenced in appearance and verbal confirmation of familial heritage with all 4 grandparents and both parents born in Japan and has not had a significant change in lifestyle or diet since leaving Japan\n* For all study participants:\n* Study participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent\n* Study participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.\n* Body weight within 40 kilograms (kg) to 110 kg and body mass index (BMI) within the range of 18 kilograms per meter square (kg\u002Fm2) to 30 kg\u002Fm2 (inclusive)\n\nExclusion Criteria:\n\n* Study participant has a history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, electrocardiogram (ECG), or vital sign that, in the opinion of the investigator, could significantly alter the absorption, or elimination of drugs; constitute a risk when taking the study intervention; or interfere with the interpretation of data\n* Study participant has a recent history (within 6 months of Screening) or currently active clinically significant bacterial, fungal, endoparasite, or viral infection.\n* Study participant has a significant allergy to humanized monoclonal antibody (mAbs)","55 Years",{"count":435,"type":20},96,[109],"The purpose of this study is to evaluate the safety and tolerability of single ascending doses of UCB5285 in healthy study participants, including healthy Japanese study participants",[392],[440],"UCB5285","2025-12-16",{"date":443,"type":35},"2025-12-23",{"date":445,"type":35},"2025-12-08",{"date":447,"type":20},"2026-12-13",{"name":41,"class":42},1,{"id":451,"slug":452,"hasResults":11,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":11,"sex":16,"minAge":457,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":21,"phases":460,"briefSummary":461,"conditions":462,"keywords":464,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":475},"100417435","phase-3-a-study-to-test-the-safety-and-tolerability-of-brivaracetam-in-children-and-adolescents-with-seizures-100417435","NCT04715646","A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures","Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy","Inclusion Criteria:\n\nInclusion criteria for long-term follow-up (LTFU) study participants only\n\n* Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 \\[NCT01364597\\] and\u002For N01349 \\[NCT03325439\\]\n\nInclusion criteria for directly enrolled (DE) study participants in Japan only\n\n* Study participant is ≥ 4 years to \\\u003C 16 years of age\n* Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years\n* Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment with at least 1 antiepileptic drug (AED)\n* Study participant had at least 1 POS during the 4-week Screening Period\n\nExclusion Criteria:\n\nExclusion criteria for all study participants\n\n* Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant\n* Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV).\n\nExclusion criteria for long-term follow-up (LTFU) study participants only\n\n\\- Study participant ≥ 6 years of age has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months as indicated on the Columbia Suicide Severity Rating Scale (C-SSRS)\n\nExclusion criteria for directly enrolled (DE) study participants in Japan only\n\n* Study participant has a history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures\n* Study participant has a history of status epilepticus in the 30 days prior to the Screening Visit (ScrV) or during the Screening Period\n* Study participant has any clinically significant illness\n* Study participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results\n* Study participant has a clinically significant ECG abnormality\n* Study participant had major surgery within 6 months prior to the ScrV","1 Month",{"count":459,"type":20},70,[23],"The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.",[463],"Epilepsy",[463,233,465,466],"Pediatric","Child","2025-06-26",{"date":469,"type":35},"2025-06-27",{"date":471,"type":35},"2021-03-11",{"date":473,"type":20},"2030-07-08",{"name":41,"class":42},36,""]