[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Oneness Biotech Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":112},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,65,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100546666","phase-2-evaluate-efficacy-and-safety-of-repeat-subcutaneous-doses-of-fb825-in-adults-with-moderate-to-severe-atopic-dermatitis-100546666",false,"NCT06397911","Evaluate Efficacy and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Pharmacokinetics, and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be included in the study:\n\n1. The subject is male or female between 18 and 65 years of age at the time of giving informed consent.\n2. Body weight equal to or greater than 40 Kg at the time of screening.\n3. The subject has a physician-confirmed diagnosis of moderate-to-severe atopic dermatitis based on 12 months history of symptoms designated by Hanifin and Rajka criteria.\n4. Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline visits.\n5. Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3 (5-point scale) at the screening and baseline visits.\n6. ≥10 % body surface area (BSA) of AD involvement at the screening and baseline visits.\n7. Baseline pruritus numerical rating scale (NRS) average score for maximum itch intensity of ≥ 3, based on the average of daily pruritus NRS scores for maximum itch intensity reported during the 7 days prior to randomization.\n8. History of inadequate response to a stable (4 weeks) regimen of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) as treatment for AD within 6 months before the screening visit. (The TCS should belong to medium to high potency strength and has been applied for at least 4 weeks or for the maximum duration recommended by product prescribing information.)\n\n   * An inadequate response is defined as the inability to achieve and maintain remission or a low disease activity state (comparable to vIGA-AD 0=clear to 2=mild).\n   * Subjects with systemic treatment for AD in the past 6 months were also considered as inadequate responders to topical treatments.\n9. Patients must be applying stable doses of an additive-free, basic bland emollient twice-daily for at least 1 week immediately before the baseline visit.\n\n   Note: See exclusion criterion #13 for limitations regarding emollients.\n10. Female subjects must have a negative serum pregnancy test at screening. All subjects of childbearing potential and his\u002Fher sexual partner must meet 2 following condition or acceptable methods of birth control throughout the study.\n\n    * Oral, injectable, or implanted hormonal contraceptives\n    * Condom with a spermicidal form, gel, film, cream, or suppository\n    * Occlusive cap (diaphragm or cervical\u002Fvault caps) with a spermicidal foam, gel, film, cream, or suppository\n    * Intrauterine device\n    * Intrauterine system (for example, progestin-releasing coil) or be surgically sterile (i.e., hysterectomy, bilateral tubal ligation, bilateral oophorectomy, or vasectomy)\n    * Postmenopausal (defined as amenorrhea 12 consecutive months and documented serum follicle stimulating hormone level per laboratory standard) Note: The subject must utilize the method of effective contraception during study period as well as 16 weeks or 5 half-lives following the last dosing of FB825.\n11. The subject is able to provide written informed consent.\n12. The subject agrees to and is capable of adhering to scheduled visits, the treatment plan, laboratory tests, other study procedures, and all protocol requirements.\n\nExclusion Criteria:\n\n* Subjects to whom any of the following applies will be excluded from the study:\n\n  1. Female subjects who are pregnant or lactating\n  2. The subject with positive test results for HBeAg or HCV RNA should be excluded as they are indications of active hepatitis B virus and hepatitis C virus replication.\n  3. A positive human immunodeficiency virus (HIV) test (e.g., HIV Ag\u002FAb combo test) at screening or a history of HIV infection.\n  4. The subject has a history of alcohol or drug abuse within one year prior to screening that would impair or risk the patients' full participation in the study, in the opinion of the investigator.\n  5. The subject has a clinically significant, currently active or severe gastrointestinal, cardiovascular, nervous system, psychiatric, metabolic, renal, hepatic, respiratory (with the exception of uncomplicated allergic rhinitis and allergic asthma), inflammatory, immunological, endocrine, diabetes, obesity \\[BMI≥35\\] or infectious disease and is ineligible to participate in the study as judged by the investigator.\n  6. The subject has a clinically significant history, as determined by the investigator, of drug allergies or hypersensitivity such as, but not limited to, sulfonamides and penicillin, or a drug allergy witnessed in a previous study with experimental drugs.\n  7. The subject has any history of a previous anaphylactic reaction.\n  8. The subject has any condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements.\n  9. The subject has received TCS or TCI within 7 days prior to the baseline visit (Day 1).\n  10. The subject has received any immunoglobulin products or blood products within 3 months prior to baseline visit.\n  11. The subject has received a biologic product (including investigational biologic product) within 5 half-lives or 3 months, whichever is longer, before baseline visit.\n  12. The subject has received an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before baseline visit.\n  13. Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period.\n  14. Initiation of treatment of AD with sedative anti-histamine products during the screening period (patients may continue using stable doses of non-sedative anti-histamine).\n  15. The subject is a member of the professional or ancillary personnel involved in the study.\n  16. The subject regular use (≥2 visits per week) of a tanning booth\u002Fparlor within 4 weeks prior to the baseline visit.\n  17. The subject has received cell-based immunotherapy treatment within 3 months prior to baseline visit.\n  18. The subject has used any of the following classes of medication (prescription or over-the-counter) within specific time frames before the study drug treatment:\n\n      * Systemic corticosteroids within 4 weeks.\n      * Leukotriene modifiers within 4 weeks.\n      * Cyclosporine within 4 weeks, or other immunosuppressants (e.g. gold salts, methotrexate, azathioprine) within 4 weeks.\n      * IFN-γ within 12 weeks, or other immunomodulating drugs within 4 weeks.\n      * Allergen immunotherapy within 1 year.\n      * JAK inhibitor within 4 weeks.\n  19. The subject has received phototherapy within 4 weeks before the study drug treatment.\n  20. The subject has received live vaccine within 12 weeks before the study drug treatment.\n  21. The subject has presence of skin comorbidities that may interfere with study assessments.\n  22. The subject has known or suspected history of immunosuppression, including history of opportunistic infections (e.g., TB) per investigator's judgment.\n  23. The subject has active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit.\n\n      Note: Patients with resolved infection may be rescreened.\n  24. The subject has history of malignancy within 5 years before the screening period, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.\n  25. The subject has planned or anticipated the use of any prohibited medications and procedures during the entire study period.\n  26. The subject has planned or anticipated major surgical procedure during the entire study period.\n  27. High risk of parasite infection. Evidence of parasitic infection designated as having the following two items:\n\n      • Risk factors for parasitic disease include living in an endemic area, experiencing chronic gastrointestinal symptoms, traveling to regions where geohelminthic infections are endemic within the last 6 months, and\u002For having chronic immunosuppression).\n\n      AND\n\n      • Evidence of parasitic colonization or infection found during stool evaluation for ova and parasites.\n\n      Note: stool ova and parasite evaluation will only be conducted in patients with risk factors and an eosinophil count more than twice the upper limit of normal.","ALL","18 Years","65 Years",{"count":20,"type":21},114,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a randomized, placebo-controlled and double-blind study to evaluate the efficacy, pharmacokinetics, and Safety of repeat subcutaneous doses of FB825 in adults with moderate-to-severe atopic dermatitis.",[27],"Atopic Dermatitis","RECRUITING","2026-06-12",{"date":31,"type":32},"2026-06-15","ACTUAL",{"date":34,"type":32},"2024-08-08",{"date":36,"type":21},"2027-05-31",{"name":38,"class":39},"Oneness Biotech Co., Ltd.","INDUSTRY",16,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100625014","phase-1-assess-the-safety-and-tolerability-of-sns851-in-healthy-participants-100625014","NCT07417124","Assess the Safety and Tolerability of SNS851 in Healthy Participants","A First-in-Human Study to Assess the Safety and Tolerability of Single and Multiple Doses of SNS851 in Healthy Participants","Inclusion Criteria:\n\n1. Able to provide written informed consent. Willing, committed, and able to return for all clinic visits and complete all protocol specified procedures.\n2. Healthy male or female, aged between 18 and 55 years, inclusive at screening.\n3. Body mass index (BMI) of greater than or equal to 18 kg\u002Fm2 and lesser than or equal to 32 kg\u002Fm2 at Screening.\n4. Negative human immunodeficiency virus, viral hepatitis B and C serology at Screening.\n5. No major changes in diet, alcohol intake, or physical activity within 4 weeks before dosing and no intention to modify during confinement or follow-up.\n6. No acute illness in the 4 weeks prior to check-in, as established by physical examination and medical history.\n7. Participant is willing to refrain from consuming caffeine and\u002For xanthene products (e.g., coffee, tea, chocolate, and caffeine-containing sodas, colas) for 12 hours before each study visit and while being confined to the study site.\n8. All participants of reproductive potential must use a highly effective contraceptive method from consent through 90 days after last dose.\n\nExclusion Criteria:\n\n1. Weight loss of more than 10% within the last 3 months prior to screening.\n2. Has any clinical safety laboratory result considered clinically significant by the Investigator (or designee)\n3. In the opinion of the PI (or designee), has evidence of other forms of known chronic liver disease\n4. Participants with history or pre-existing renal disease\n5. Relevant history (in the opinion of the PI or designee) of cardiac arrythmias including long QT syndrome, sudden cardiac death, or Torsades de Pointes and\u002For syncope and\u002For clinically significant cardiovascular event or history of uncontrolled hypertension or orthostatic hypotension within the last 6 months prior to the Screening Visit.\n6. QTcF interval duration \\> 450 msec for male or \\> 470 msec for female at Screening or Day 0.\n7. Evidence or history of clinically significant pulmonary and respiratory diseases, including any clinically significant pulmonary disease or sequelae of COVID-19 infection that may increase risk from study participation.\n8. Use of an investigational agent or device within 30 days or 5 half-lives since last dose of prior investigational product or device of Day 1 drug administration in this trial, whichever is longer prior to dosing or current participation in an investigational study.\n9. History of having received long-duration RNA-based therapies within 12 months of Day 1.\n10. Use of any prescription medication or concomitant medications within 14 days prior to the first dose of study drug, or use of over-the-counter medication\u002Fvitamins\u002Fsupplements within 7 days prior to the first dose of study drug. Exceptions include contraception, iron supplements for participants who have ferritin between 15-30 µg\u002FL at screening, occasional paracetamol (up to a maximum of 2 grams per day).\n11. Use of any vaccinations within 14 days prior to the first study drug administration.\n12. Use of anabolic steroids and systemic treatment with glucocorticosteroids within 3 months prior to the Screening Visit.\n13. History of substance dependence (within the last 12 months) or positive urine drug screen at screening or positive alcohol breath tests at screening.\n14. Urinary cotinine levels at screening are indicative of smoking or participant has a history of regular use of tobacco- or nicotine-containing products.\n15. Any clinically significant illness, medical\u002Fsurgical procedure, or trauma within 4 weeks of the first administration of study intervention.\n16. In the opinion of the PI (or designee), has an aversion to, or has history of site reactions to Subcutaneous administrations that would make them unsuitable for inclusion in this trial.\n17. Has donated blood or blood products within 3 months prior to first dose administration.\n18. Presence or evidence of recent sunburn, scar tissue, tattoo, open sore or branding that, in the opinion of the PI or medically qualified designee, would interfere with the interpretation of skin adverse reactions at the injection site\n19. In the opinion of the PI (or designee), has any uncontrolled or serious disease, medical or surgical condition that may interfere with participation or data interpretation.\n20. Any other condition or prior therapy that in the opinion of the PI (or designee) would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.\n21. History of hypersensitivity to oligonucleotide therapeutics or injection-site reactions.",true,"55 Years",{"count":51,"type":21},52,[53],"PHASE1","This is a Phase I, randomized, double-blind study designed to evaluate the safety, tolerability and pharmacokinetics of subcutaneous administration of SNS851 in healthy participants.",[56],"Metabolic Disease","2026-06-10",{"date":29,"type":32},{"date":60,"type":32},"2026-04-01",{"date":62,"type":21},"2026-10",{"name":38,"class":39},1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100439951","phase-2-evaluate-the-efficacy-and-safety-of-fb825-in-adult-with-allergic-asthma-100439951","NCT05008965","Evaluate the Efficacy and Safety of FB825 in Adult With Allergic Asthma","A Phase II Study to Evaluate the Efficacy and Safety of FB825 in Adult Patients With Moderate-to-severe Allergic Asthma","Inclusion Criteria:\n\n1. Male or females 18-75 years old.\n2. Subjects diagnosed with moderate-to-severe allergic asthma \\[Global Initiative for Asthma \\[GINA\\]; GINA, 2021) at least 12 months prior to Visit 1.\n3. Documented reversibility from historical data of at least 12% and 200 mL in FEV1 after the administration of 200 to 400 mcg albuterol\u002Fsalbutamol (or other standard office practice) OR documented airway hyperresponsiveness (methacholine PC20 \\\u003C 8 mg\u002FmL \\[or PC20 \\\u003C 16 mg\u002FmL on ICS\\]) OR airflow variability in clinic FEV1 \\>12% and 200 mL between visits outside of respiratory infections, documented in the past 24 months prior to Visit 1 if documented reversibility and airway hyperresponsiveness data are not available.\n4. Subjects must have a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% predicted within 2 months from randomization.\n5. Subjects must have received a physician-prescribed asthma regimen with medium- or high-dose ICS plus LABA for at least 3 month prior to Visit 1 and the dose of ICS must be stable for at least 30 days prior to Visit 1 and throughout the screening period.\n\n   1. High-dose ICS is defined as total daily dose of \\>500 mcg fluticasone propionate or equivalent\n   2. Medium-dose ICS is defined as a total daily dose of 250 to 500 mcg fluticasone propionate or equivalent.\n   3. Equivalence ICS doses will be based upon the GINA guidelines (GINA, 2021)\n   4. According to the medical history, subject have no more than a maximum of 2000 mcg\u002Fday equipotent ICS daily dosage of fluticasone propionate or equivalent in 3 months before visit 1.\n6. Prior to screening, subjects must be on a stable dose of any of the following doses and formulations of ICS\u002FLABA combination therapy for at least 1 month:\n\n   1. Fluticasone\u002Fsalmeterol combination therapy\n\n      * Advair® Diskus - dry powder inhaler (DPI): 250\u002F50 μg BID or 500\u002F50 μg BID, or\n      * Advair® HFA - metered dose inhaler (MDI): 230\u002F42 μg BID or 460\u002F42 μg BID, or\n   2. Budesonide\u002Fformoterol combination therapy (Symbicort® -160\u002F4.5 μg BID or 320\u002F9 μg BID), or\n   3. Mometasone\u002Fformoterol combination therapy (Dulera® -200\u002F10 μg BID or 400\u002F10 μg BID).\n   4. Other equivalents medium to-high dose medication following the GINA guidelines (GINA, 2021)\n7. Subjects must have a documented history of protocol-defined asthma exacerbation at least 1 or more times within the 12 months.\n8. A total serum IgE ≥ 125 IU\u002FmL during screening prior to randomization.\n9. Subjects must have at least one positive in skin prick test or at least one environmental allergen-specific IgE greater than normal range.\n10. Uncontrolled asthma demonstrated both during the screening period and at the time of randomization defined as ACQ-5 (5-item Asthma Control Questionnaire) ≥ 1.5\n11. If recently treated for respiratory tract infection, the treatment must have been completed at least 4 weeks prior to screening. Subjects who have an upper respiratory tract infection during screening are allowed to be rescreened 4 weeks after resolution.\n12. Female subjects of childbearing potential must use at least two forms of birth control. One must be barrier protection (i.e., condom or female condom) and the other is one of acceptable method of birth control (ie, diaphragm, intrauterine device, hormonal contraceptives, or abstinence) throughout the study. Subjects who are surgically sterile (ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), or postmenopausal (defined as amenorrhea for 12 consecutive months and documented serum follicle stimulating hormone level \\>40 mU\u002FmL) will be considered as no childbearing potential. All female subjects of child-bearing potential must have a negative serum pregnancy test at screening.\n\n    Note: The subject must use the methods of contraception mentioned above during study period and at least 120 days after the last dosing of FB825.\n13. The subject has a body weight ≥ 40 kg at screening.\n14. The subject has a normal or non clinically significant abnormal, as determined by the investigator, 12-lead electrocardiogram (ECG).\n15. The subject is able to provide written informed consent.\n16. The subject agrees to comply with all protocol requirements.\n\nExclusion Criteria:\n\n1. Asthma exacerbation or any other reason requiring systemic steroids in the 30 days prior to randomization. Subjects are allowed to be rescreened 30 days after completion of treatment.\n2. \\>20% relative change in post-bronchodilator FEV1 between screening and randomization.\n3. Female subjects who are pregnant or lactating.\n4. A positive human immunodeficiency virus (HIV) test (e.g., HIV Ag\u002FAb combo test) at screening or subject taking antiretroviral medications, as determined by medical history.\n5. Patients with positive HBeAg or HCV RNA results should be excluded as they are indications of active Hepatitis B virus and Hepatitis C virus replication.\n6. Active lung diseases (e.g., bronchitis, chronic obstructive pulmonary disease) other than allergic asthma.\n7. Use of any experimental drug within 30 days or 5 half-lives, whichever is longer, prior to or during the screening period.\n8. Current or history of treatment with a monoclonal antibody, for example, IL-4, IL-5, IL-13 or IL-15 antibody treatment within 6 months prior to the screening.\n9. Current or history of treatment with anti-IgE antibody treatment within 6 months or 5 half-lives, whichever is longer.\n10. The subject has a history of alcohol or drug abuse that would impair or risk the patients' full participation in the study, in the opinion of the investigator.\n11. The subject has any condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements.\n12. The subject has indication of severe liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate transaminase (AST) above 3x upper limits of normal (ULN) or elevated total bilirubin \\>2x ULN as determined at screening.\n13. The subject has severe kidney disease, defined as estimated GFR \\\u003C30ml\u002Fmin\u002F1.73m2 or creatinine \\> 3x ULN.\n14. The subject has known or suspected history of immunosuppression or immunodeficiency.\n15. Known history of active tuberculosis (TB) or evidence of tuberculosis infection as defined by a positive purified protein derivative (PPD) skin test and\u002For interferon-gamma release assay. The interferon-gamma release assay should be repeated in case of an indeterminate result.\n16. The subject has history of malignancy within 5 years before the screening period. Patients with non-invasive carcinoma in-situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin may be eligible if they have undergone curative resection at least 12 months prior to screening.\n17. Current smoker with \\> 10 packs year prior to screening. A smoker is defined as a subject who has taken inhaled nicotine containing products (e.g. cigarette, cigar, pipe), including e-cigarettes prior to screening.\n18. High risk of parasite infection\n\n    • Risk factors for parasitic disease (living in an endemic area, travel within the last 6 months to regions where geohelminthic infections are endemic, and\u002For chronic immunosuppression).\n\n    AND\n\n    • Evidence of parasitic colonization or infection on stool evaluation for ova and parasites.\n\n    Note: stool ova and parasite evaluation will only be conducted in patients with risk factors and an eosinophil count more than twice the upper limit of normal.\n19. The subject has received live vaccine within 12 weeks or COVID-19 vaccination within 2 weeks prior to dosing or planned live attenuated vaccinations during the study.\n20. The subject has a history of any clinically relevant arrhythmias as determined by the investigator.\n21. The subject has a history of respiratory failure or near fatal asthma events which resulted in intensive care unit admission or intubation within five years before the screening period.\n22. History of anaphylaxis to any biologic therapy.\n23. The subject has major surgery, for example organ replacement, joint replacement, full hysterectomy, heart surgeries, within 8 weeks before the screening. The subject who has major surgery prior to 8 weeks of screening should have fully recovered from any surgical procedures.\n24. The subject has comorbid disease that might interfere with the evaluation of IMP (investigational medicinal product) or conduct of study procedures (eg, bronchodilator test).\n25. The subject requiring non-selective beta-adrenergic receptor blockers for any reason and initiation or dose change of a selective beta-1 adrenergic receptor blocker within 3 months prior to Visit 1.\n26. The subject who received bronchial thermoplasty within 3 years of Visit 1 OR patients who plan to begin therapy during the Screening Period or the Randomized Treatment Period.\n27. The subject with active autoimmune disease (excluding atopic dermatitis) or patients using immunosuppressive therapy for autoimmune disease (excluding atopic dermatitis) (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.) or patients with high titer autoantibodies at screening who are suspected of having high risk for developing autoimmune disease at the discretion of the Investigator or the Sponsor.\n28. Use of Traditional Chinese Medications, those that are listed in the Prohibited Medication, for the treatment of asthma within 3 months prior to screening.\n29. Aggravating factors that are inadequately controlled e.g., medication uncontrolled gastroesophageal reflux disease.\n30. The subject has adrenal insufficiency (ACTH-resistant) by rapid ACTH stimulation test due to known history of adrenal insufficiency or being suspected of adrenal insufficiency or long-term use of systemic corticosteroids (annual average more than 6 months in the past two years).\n\n    Adrenal insufficiency: after 30 minutes of ACTH injection, the cortisol level ≦20 mg\u002Fml in rapid ACTH stimulation test.\n31. History of prior positive SARS-CoV-2 diagnostic test (antigen or NAAT\u002FPCR) within 3 months prior to screening.","75 Years",{"count":74,"type":21},100,[24],"This is a randomized, placebo-controlled and double-blind study to evaluate the efficacy and safety of FB825 in adult patients with moderate-to-severe allergic asthma.",[78],"Allergic Asthma","2026-01-09",{"date":81,"type":32},"2026-01-12",{"date":83,"type":32},"2021-07-27",{"date":85,"type":21},"2027-12",{"name":38,"class":39},13,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100440669","phase-2-evaluate-the-efficacy-and-safety-of-fb704a-in-adult-with-severe-asthma-100440669","NCT05018299","Evaluate the Efficacy and Safety of FB704A in Adult With Severe Asthma","A Randomized, Placebo Controlled, Double Blind Phase IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Multiple Intravenous Doses of FB704A in Adults With Severe Asthma","Inclusion Criteria:\n\n1.18 to ≦75 years of age, either sex, any race. 2.Diagnosed as severe asthma based on 2020 GINA guideline. 3.An ACT score is \\\u003C20. 4.Induced sputum neutrophil count ≧50% of total sputum cells during Screening. 5.Documented diagnosis of severe asthma within past 5 years. Additionally, subjects must have at least one of the following: a) ≧12% and\u002For 200 mL improvement in Forced Expiratory Volume in 1 second (FEV1) post-bronchodilator, OR b) airway hyperresponsiveness (e.g., positive methacholine challenge \\\u003C8 mg\u002FmL), OR c) within the past 24 months, airway variability with a ≧12% and 200 mL change in FEV1 between clinic visits outside of respiratory infections, documented prior to Visit 1, OR d) within the past 24 months, average daily PEF variability \\> 10% over a 2-week period, documented prior to Visit 1.\n\n6.Nonsmoker or previous smoker with cumulative smoking history less than 10 pack-years (pack-year = 20 cigarettes smoked daily for 1 year). Previous smokers may not have smoked within 1 year prior to Screening. A smoker is defined as a subject who has taken inhaled nicotine containing products (e.g. cigarette, cigar, pipe), including e-cigarettes prior to screening.\n\n7.Must not have had a severe asthma exacerbation of asthma for 4 weeks prior to Screening and must be on a stable medication regimen for asthma at least 4 weeks prior to Screening.\n\nA Severe asthma exacerbation is defined as a deterioration of asthma leading to treatment for 3 days or more with systemic glucocorticoids or hospitalization or an emergency department visit leading to treatment with systemic glucocorticoids.\n\n8.Must be willing to give written informed consent to participate in the study. 9.Must be capable of complying with the dosing regimen, adhere to the visit schedule, and participate in all treatment procedures, including sputum induction.\n\n10.Female subject of childbearing potential must have a negative serum pregnancy test at Screening and must be using a medically acceptable, highly effective, adequate form of birth control (ie, failure rate \\\u003C1% per year when used consistently and correctly) prior to Screening and agree to continue using it while in the study (Screening and Treatment Periods). Medically acceptable, highly effective forms of birth control are hormonal implants, oral contraceptives, medically acceptable prescribed intrauterine devices (IUDs), and monogamous relationship with a male partner who has had a vasectomy. Female subject who is not of childbearing potential must have a medical record of being surgically sterile (eg, hysterectomy, tubal ligation), or be at least 1 year postmenopausal. Absence of menses for at least 1 year will indicate that a female is postmenopausal. A female subject should be encouraged to continue using a highly effective method of birth control for 30 days following the end of treatment.\n\nMale subject must agree to use an adequate form of contraception for the duration of the study and agree to have sexual relations only with women who use a highly effective birth control method.\n\nExclusion Criteria:\n\n1.Chronic Obstructive Pulmonary Disease (COPD)\u002Fother relevant lung disease (other than asthma) 2.4 weeks prior to\u002For Screening: upper\u002Flower respiratory tract infection 3.Screening: Inadequate amount or difficulty producing sputum 4.Screening: Sputum neutrophil count over 10 million\u002FmL 5.Screening: peripheral blood neutrophil (PBN) count \\\u003C2000\u002FµL 6.Clinically significant chronic infectious disease(s) (eg, Human Immunodeficiency Virus \\[HIV\\], hepatitis B or C) 7.Allergy\u002Fsensitivity to study drug\u002Fexcipients 8.Breast-feeding, pregnant\u002Fintends to become pregnant during study 9.Requiring mechanical ventilation for respiratory event within 6 months of Screening 10.Medical condition(s) (eg, hematologic, cardiovascular, renal, hepatic, neurologic, or metabolic) or medication that may interfere with effect of study medication 11.Within 30 days of Screening: any other investigational drug 12.Known history of active tuberculosis (TB) or evidence of tuberculosis infection as defined by a positive purified protein derivative (PPD) skin test and\u002For interferon-gamma release assay. The interferon-gamma release assay should be repeated in case of an indeterminate result 13.Active infection, including opportunistic infections, requiring systemic therapy within the past 2 weeks 14.A deep space infection within the past 2 years (including, but not limited to meningitis, epiglottitis, endocarditis, septic arthritis, fasciitis, abdominal or pleural abscess, or osteomyelitis) 15.History of diverticulitis, diverticulosis requiring antibiotic treatment, or other symptomatic lower gastrointestinal (GI) conditions that might predispose to perforations 16.Immunization with a live\u002Fattenuated vaccine within 4 weeks prior to treatment 17.Evidence of active malignant disease, malignancies diagnosed within the previous 5 years (including hematological malignancies and solid tumors, except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured) 18.Liver enzymes: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\> 3x upper limit of normal 19.Serum bilirubin \\> 2x upper limit of normal 20.Low platelet count (\\\u003C100,000\u002Fmm3) 21.Dyslipidemia. 22.Participation in any other clinical study. 23.Part of the staff personnel involved with the study. 24.Family member of investigational study staff.",{"count":96,"type":21},20,[24],"This is a randomized, placebo controlled and double blind study to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of FB704A in adult patients with severe asthma. The study comprised a 4-week screening period, a 8-week treatment period and a 12-week follow-up period.",[100],"Severe Asthma",[102],"Asthma","2025-12-02",{"date":105,"type":32},"2025-12-09",{"date":107,"type":32},"2021-09-30",{"date":109,"type":21},"2026-05-08",{"name":38,"class":39},9,""]