EUCTR2018-001543-30-BE进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2A STUDY TO ASSESS THE EFFICACY AND SAFETY OF REGN3500 MONOTHERAPY AND COMBINATION OF REGN3500 PLUS DUPILUMAB IN ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female, 18 to 75 years
- •2. Chronic AD, according to American Academy of Dermatology Consensus Criteria (Eichenfield, 2014), that has been present for at least 3 years before the screening visit
- •3. EASI score =16 at the screening and baseline visits
- •4. IGA score =3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at screening and baseline visits
- •5. =10% BSA of AD involvement at the screening and baseline visits
- •6. Baseline peak Pruritus NRS score for maximum itch intensity =4
- •7. Documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments are medically inadvisable (eg, intolerance, because of important side effects, or safety risks).
- •8. Have applied a stable dose of topical bland emollient (moisturizer) at least twice daily for at least the 7 consecutive days immediately before randomization
- •9. Willing and able to comply with all clinic visits and study-related procedures
- •10. Provide informed consent signed by study patient or legally acceptable representative
- •11. Able to understand and complete study-related questionnaires
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Prior participation in a REGN3500 (anti-IL-33) or dupilumab (anti-IL-4Ra) clinical study; past treatment with or current treatment with dupilumab
- •2. Body mass index <16 kg/m2
- •3. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
- •4. Having used any of the following treatments within 4 weeks before the baseline visit or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment: Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-?, Janus kinase inhibitors, azathioprine, methotrexate, etc) Phototherapy for AD
- •5. Treatment with TCS, TCI, or topical crisaborole within 1 week before the baseline visit
- •6. Treatment with biologics as follows: Any cell-depleting agents including but not limited to rituximab: within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever is longer Other biologics: within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever is longer
- •7. 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
- •8. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit
- •9. Planned or anticipated use of any prohibited medications and procedures during study treatment
- •10. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
- •11. 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
- •12. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment
- •13. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
- •14. Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCV Ab) at the screening visit
- •15. At baseline, presence of any conditions listed as criteria for study drug discontinuation
- •16. Presence of skin comorbidities that may interfere with study assessments
- •17. History of cancer, with the exceptions of: Patients with adequately treated basal cell carcinoma or carcinoma in situ of the
- •cervix. Patients with other malignancies that have been successfully treated for >10 years prior to screening where, in the judgement of both the investigator and the treating physician, appropriate follow-up has revealed no evidence of recurrence through time of screening.
- •18. Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization
- •19. History of alcohol or drug abuse within 2 years of the screening visit
- •20. Severe concomitant illness(es) that, in the investigator’s judgment, would adversely affect the patient’s participation in the study.
- •21. Any other medi
研究者
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