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
Status: | Recruiting |
---|---|
Conditions: | Psoriasis, Dermatology, Dermatology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 1/13/2019 |
Start Date: | November 12, 2018 |
End Date: | August 28, 2020 |
Contact: | Clinical Trials Administration |
Email: | clinicaltrials@regeneron.com |
Phone: | 844-734-6643 |
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
The primary objective of the study is to evaluate the efficacy of REGN3500 monotherapy
compared with placebo treatment in adult patients with moderate-to-severe Atopic dermatitis
(AD).
Secondary Objectives are to:
- Evaluate the efficacy of REGN3500 in combination with dupilumab compared with placebo
treatment in adult patients with moderate-to-severe AD
- 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
- Evaluate the Pharmacokinetic (PK) of REGN3500 monotherapy and REGN3500 in combination
with dupilumab in adult patients with moderate-to-severe AD
compared with placebo treatment in adult patients with moderate-to-severe Atopic dermatitis
(AD).
Secondary Objectives are to:
- Evaluate the efficacy of REGN3500 in combination with dupilumab compared with placebo
treatment in adult patients with moderate-to-severe AD
- 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
- Evaluate the Pharmacokinetic (PK) of REGN3500 monotherapy and REGN3500 in combination
with dupilumab in adult patients with moderate-to-severe AD
Key Inclusion Criteria:
1. 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
2. Eczema Area and Severity Index (EASI) score ≥16 at the screening and baseline visits
3. ≥10% Body surface area (BSA) of AD involvement at the screening and baseline visits
4. 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
Key Exclusion Criteria:
1. Prior participation in a REGN3500 (anti-Interleukin (IL)-33) or dupilumab
(anti-IL-4Rα) clinical study; past treatment with or current treatment with dupilumab
2. Active chronic or acute infection requiring treatment with systemic antibiotics,
antivirals, antiparasitics, antiprotozoals, or antifungals 2 weeks before the baseline
visit, or superficial skin infections within 1 week before the baseline visit
3. 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
4. History of human immunodeficiency virus (HIV) infection or positive HIV serology at
screening
5. Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb),
or hepatitis C virus antibody (HCV Ab) at the screening visit
6. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
during the study
Note: Other protocol defined Inclusion/Exclusion Criteria apply
We found this trial at
3
sites
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