drugset / Trial / NCT03736967
Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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
Timeline
- Start
- 2018-11-12
- Primary completion
- 2020-03-13
- Completion
- 2020-07-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dupilumab | Monoclonal antibody | — | Subcutaneous |
| Subject | Itepekimab | Monoclonal antibody | — | Subcutaneous |