A Safety and Efficacy Study in Adult Patients with Moderate to Severe Atopic Dermatitis
- Conditions
- Moderate to Severe Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-001543-30-NL
- Lead Sponsor
- Regeneron Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 280
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
1. Prior participation in an anti-IL-33 class antibody (including but not limited to REGN3500) or anti-IL-4Ra class antibody (including but not limited to dupilumab) clinical study; past treatment with or current treatment with dupilumab or another anti-IL-4Ra treatment.
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 con
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): The primary endpoint in the study is the percent change in EASI score from baseline to week 16.;Timepoint(s) of evaluation of this end point: Week 16;Main Objective: The primary objective of the study is to evaluate the efficacy of REGN3500 monotherapy compared with placebo treatment in adult patients with<br>moderate-to-severe atopic dermatitis (AD).;Secondary Objective: -To evaluate the efficacy of REGN3500 in combination with dupilumab compared with placebo treatment in adult patients with moderate-to-severe AD<br>-To assess the safety, tolerability, and immunogenicity of subcutaneous (SC) doses of REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with moderate-to-severe AD<br>-To evaluate the pharmacokinetics (PK) of REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with moderate-to-severe AD
- Secondary Outcome Measures
Name Time Method