[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-pruritus-of-unknown-origin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-pruritus-of-unknown-origin":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100054294","phase-3-a-study-to-evaluate-efficacy-safety-and-tolerability-of-remibrutinib-in-adult-participants-with-severe-chronic-pruritus-of-unknown-origin-cpuo-100054294",false,"NCT07700056","A Study to Evaluate Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)","A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)","Key Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age, at the time of signing the informed consent.\n* Participants with chronic pruritus for at least 4 months prior to screening.\n* Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (e.g., excluding chronic pruritus related to primary dermatological or systemic conditions, neuropathic or psychogenic origin or secondary to drugs or other allergen exposures).\n* Chronic pruritus must affect at least 2 of the following body areas: trunk, arms, or legs (cannot be unilateral and\u002For dermatomal in distribution).\n* Participants with ongoing, severe chronic pruritus despite the use of emollients and who are candidates for systemic therapy.\n* Participants must have severe itch defined by a WI-NRS ≥7 at screening; score scale ranges from 0 to 10; higher score indicates worse itch.\n* Participants must have an average WI-NRS ≥7 over the 7 days prior to randomization\u002Fbaseline visit.\n* The average WI-NRS score over the preceding 7 days prior to the randomization\u002Fbaseline visit will be calculated based on the daily WI-NRS scores (0-10).\n* Participants must have PGIS of pruritus scored as 3 \"severe\" at screening and baseline visits.\n\nKey Exclusion Criteria:\n\n* Any active skin conditions (e.g., atopic dermatitis, psoriasis, etc.) that may interfere with the assessment of CPUO.\n* Known systemic condition(s) or medication(s) that are considered by the investigator to be the primary cause of current pruritus.\n* Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the clinical trial as per Investigator´s assessment. These infectious diseases include but are not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and\u002For known or suspected HIV infection.\n* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.\n* Significant bleeding risk or coagulation disorders. History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAIDs), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion). Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg\u002Fd or clopidogrel up to 75 mg\u002Fd. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.\n* History or current hepatic disease, including but not limited to, acute or chronic hepatitis, cirrhosis or hepatic failure or aspartate aminotransferase (AST)\u002F alanine aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at screening.","ALL","18 Years",{"count":19,"type":20},180,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The purpose of this phase 3 study is to establish the efficacy, safety and tolerability of remibrutinib in adult participants with severe chronic pruritus of unknown origin (CPUO).",[26],"Chronic Pruritus of Unknown Origin",[28,29,30,31,32],"BTK inhibitor","chronic pruritus","chronic pruritus of unknown origin","CPUO","remibrutinib","NOT_YET_RECRUITING","2026-07-07",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":20},"2026-08-14",{"date":41,"type":20},"2030-04-15",{"name":43,"class":44},"Novartis Pharmaceuticals","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":31,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100598706","phase-2-proof-of-concept-study-to-assess-the-pharmacokineticspharmacodynamics-of-nemolizumab-in-adults-with-chronic-pruritus-of-unknown-origin-cpuo-100598706","NCT07074977","Proof of Concept Study to Assess the Pharmacokinetics\u002FPharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPUO)","An Exploratory Proof of Concept Study to Assess the Pharmacokinetics\u002FPharmacodynamics (PK\u002FPD) of Nemolizumab in Adult Participants With Chronic Pruritus of Unknown Origin (CPUO)","Inclusion Criteria:\n\n* Participants are eligible to be included in the study only if all of the following criteria apply:\n\n  1. Participant must be 18 years of age or older.\n  2. Participants with chronic pruritus on normal-appearing skin (except for dry skin or excoriations) for at least 6 months before the screening visit.\n  3. Chronic pruritus considered of unknown origin (i.e., without a clear association to another condition or medication) as assessed by the investigator at baseline.\n  4. The pruritus must affect at least 4 of the following body areas: left lower limb, right lower limb, left upper limb, right upper limb, anterior trunk, posterior trunk.\n  5. History of insufficient control of the chronic pruritus with prior treatment.\n  6. Peak Pruritus Numeric Rating Scale (PP NRS) score greater than and equal to (\\>=) 7 in the 24-hour period prior to the Screening visit.\n  7. Weekly average Peak Pruritus Numeric Rating Scale (PP NRS) score \\>= 7 in the week (7 days) immediately prior to randomization, as recorded in the patient diary.\n  8. Female of childbearing potential must agree to use at least 1 adequate and approved method of contraception throughout the study and for 12 weeks after the last study intervention injection.\n\n     Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n  9. Females of non-childbearing potential must meet 1 of the following criteria:\n* Absence of menstrual bleeding for 1 year prior to screening without any other medical reason, confirmed with follicle stimulating hormone (FSH) level in the postmenopausal range\n* Documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months before screening 10. Signed informed consent. 11. Participant is willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply :\n\nMedical Conditions\n\n1. Known dermatologic, systemic, neurologic or psychiatric condition(s), other than dry skin, that considered by the investigator to be the primary cause of current pruritus.\n2. Documented parasitic infection, including skin parasites such as scabies, within 12 weeks prior randomization.\n3. Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit.\n4. Diagnosis of chronic pruritus of neuropathic origin including but not limited to scalp dysesthesia, brachioradial pruritus, generalized neuropathic pruritus or chronic pruritus of psychogenic origin (pruritus associated with psychological disorders such as delusional parasitosis or Morgellons disease).\n5. Any medical or psychological condition or any clinically relevant laboratory abnormalities that put the participant at significant risk.\n6. History of bullous pemphigoid or positive bullous pemphigoid autoantibodies at screening.\n7. History of mastocytosis or serum total tryptase greater than (\\>) 20 nanograms per milliliter (ng\u002Fml) at screening.\n8. Active tuberculosis (TB) or non-tuberculosis mycobacterial infection, or a history of incompletely treated TB.\n9. Positive serology results Hepatitis B surface antigen or (HBsAg) or Antibody to Hepatitis B core antigen (HBcAb), Hepatitis C virus (HCV) antibody with positive confirmatory test for HCV (e.g., polymerase chain reaction \\[PCR\\]), or Human Immunodeficiency Virus \\[HIV\\] antibody) at the screening visit.\n10. Known or suspected immunodeficiency.\n11. Lymphoproliferative disease or malignancy within the last 5 years.\n12. Presence of major psychiatric diagnosis, clinically significant dementia, intellectual impairment, or any medical condition or disability which, in the investigator's opinion, may confound the assessment of nemolizumab's safety or efficacy or interfere with the participant's ability to comply with protocol mandated activities.\n13. Receipt of prohibited medications within the specified timeframe before the baseline visit\n14. Previous participation in a clinical study with nemolizumab\n15. Currently participating or participated in any other study of an investigational drug or device, within the past 8 weeks (or 5 half-lives of the investigational drug, whichever is longer) before the screening visit, or is in an exclusion period (if verifiable) from a previous study.\n16. Body weight \\\u003C 30 kg.\n17. Prior treatment with commercially available nemolizmab\n18. Hypersensitivity to the active substance (nemolizumab) or to any of the excipients of the study intervention.\n19. Requiring rescue therapy for pruritus during the screening period.\n20. Alcohol or substance abuse within 6 months of the screening visit.\n21. Planned or anticipated major surgical procedure or other activity that would interfere with the participant's ability to comply with protocol-mandated assessments.\n22. Pregnant or breastfeeding female, or female planning a pregnancy during the study.\n23. Vulnerable participant as defined by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":53,"type":20},50,[55],"PHASE2","The primary objective of this study is to assess the PK\u002FPD relationship of nemolizumab in adult participants aged 18 years or above with chronic pruritus of unknown origin (CPUO) during a 16-week treatment period.",[26],"RECRUITING","2026-05-28",{"date":61,"type":37},"2026-06-01",{"date":63,"type":37},"2025-10-20",{"date":65,"type":20},"2027-01",{"name":67,"class":44},"Galderma R&D",26]