Atopic dermatits MedDRA version: 17.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Product Name: REGN668/SAR231893
Product Code: REGN668/SAR231893
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dupilumab
CAS Number: 1190264-60-8
Current Sponsor code: REGN668/SAR231
Sponsors
Regeneron Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients with moderate to severe atopic dermatitis whose disease cannot be adequately controlled with topical medications 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Prior treatment with REGN668 2. Recent treatment (within specific time windows before the baseline visit) with systemic corticosteroids, immunosuppressive agents, topical corticosteroids and calcineurin inhibitors, live (attenuated) vaccine, other investigational drugs 3. History of human immunodeficiency virus (HIV) infection 4. HIV or viral hepatitis seropositivity at screening 5. Known or suspected immunosuppresion 6. Recent infections requiring antiinfectious treatment 7. Recent history or high risk of clinical endoparasitoses 8. High risk populations (low life expectancy, severe concomitant diseases, etc.) 9. Pregnant or breast-feeding women 10. Female patients of reproductive potential and sexually active who are unwilling to use adequate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the efficacy of multiple REGN668 dose-regimens, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).;Secondary Objective: The secondary objectives of the study are: • To assess the safety of multiple REGN668 dose-regimens, compared to placebo, in adult patients with moderate-to-severe AD • To assess the pharmacokinetics (PK) of multiple REGN668 dose-regimens in adult patients with moderate-to-severe AD • To assess the potential immune response across multiple REGN668 dose-regimens, and to compare to placebo, in adult patients with moderate-to-severe AD ;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: Throughout the duration of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Throughout the duration of the study;Secondary end point(s): The secondary endpoints include: • Proportion of patients achieving IGA 0 (clear) or 1 (almost clear) at week 16 • Proportion of patients achieving IGA score reduction of =2 at week 16 • Absolute change in EASI scores from baseline to week 16 • Absolute and percent change in SCORAD scores from baseline to week 16 • Proportion of patients achieving EASI-50, EASI-75, and EASI-90 (50, 75, and 90% reduction from baseline in EASI score) at week 16 • Proportion of patients achieving SCORAD-50, SCORAD-75, and SCORAD-90 (50, 75, and 90% reduction from baseline in SCORAD score) at week 16 • Absolute and percent change from baseline in pruritus scores (NRS and 4-point categorical scale) • Absolute and percent change from baseline in POEM scores • Changes from baseline in GISS components (erythema, infiltration/population, excoriations, and lichenification) • Changes from baseline in GISS cumulative score • Incidence of treatment-emergent adverse events (TEAEs) from baseline through week 32 • Concentration-time profile of functional REGN668 following multiple REGN668 dose-regimens | — |
Countries
Canada, Czech Republic, Germany, Hungary, Japan, Poland, United States
Outcome results
None listed