EUCTR2018-001544-64-ES进行中（未招募）1 期
A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY INVESTIGATING THE EFFICACY, SAFETY, AND PHARMACOKINETIC PROFILES OF REGN3500 ADMINISTERED TO ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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 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 the baseline visit (ie, baseline/randomization visit would be the eighth day; see exclusion criterion 7 regarding restrictions on the kind of emollients permitted during the study).
- •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 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Participation in a prior anti-IL-33 class medication clinical study
- •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 (including dupilumab): 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
- •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 them 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. Examples include, but are not limited to, patients with short life expectancy, patients with uncontrolled diabetes (hemoglobin A1c [HbA1c] =9%), patients with uncontrolled cerebrocardio vascular conditions (eg, myocardial infarction [MI], unstable arterial hypertension, unstable angina, c
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