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

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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


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
Forest Hills, New York 11375
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Forest Hills, NY
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Fountain Valley, California 92708
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Fountain Valley, CA
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Norman, Oklahoma 73071
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Norman, OK
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