A Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose Study of the Efficacy, Safety, Tolerability, and Pharmacodynamics of Subcutaneously-Administered REGN668 in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Atopic Dermatitis
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 109
- Primary Endpoint
- Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 12- Last Observation Carried Forward (LOCF)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The primary objective was to assess the clinical efficacy of repeated subcutaneous (SC) doses of Dupilumab in adult participants with moderate-to-severe atopic dermatitis (AD).
Investigators
Eligibility Criteria
Inclusion Criteria
- •The inclusion criteria included, but were not limited to the following:
- •Male or female, 18 years or older;
- •Chronic Atopic Dermatitis (AD) for at least 3 years;
- •History of inadequate response to a stable (\>/= 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit.
Exclusion Criteria
- •Prior treatment with REGN668;
- •Presence of certain laboratory abnormalities at the screening visit;
- •Treatment with an investigational drug within 8 weeks ;
- •Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
- •Certain treatments and medical procedures, undertaken within a particular time-frame prior to the baseline visit, preclude eligibility for participation in the study;
- •Known history of human immunodeficiency virus (HIV) infection;
- •History of malignancy within 5 years before the baseline visit, with certain exceptions;
- •Planned surgical procedure during the length of the patient's participation in this study;
- •History of clinical parasite infection;
- •Any medical or psychiatric condition which in the opinion of the investigator or the sponsor's medical monitor, would place the participant at risk, interfere with participation in the study, or interfere with the interpretation of study results;
Arms & Interventions
Placebo
Placebo (for Dupilumab) once weekly for 12 weeks by subcutaneous (SC) injection.
Intervention: Placebo
Dupilumab 300 mg
Dupilumab 300 mg once weekly for 12 weeks by SC injection.
Intervention: Dupilumab
Outcomes
Primary Outcomes
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 12- Last Observation Carried Forward (LOCF)
Time Frame: Baseline to Week 12
The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF.
Secondary Outcomes
- Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 12- LOCF(Week 12)
- Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI-50) at Week 12- LOCF(Week 12)
- Change From Baseline in EASI Score at Week 12- LOCF(Baseline to Week 12)
- Percent Change From Baseline in IGA Score at Week 12- LOCF(Baseline to Week 12)
- Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 12 - LOCF(Baseline to Week 12)
- Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 12- LOCF(Baseline to Week 12)
- Change From Baseline in Pruritus Numerical Rating Scale (NRS) to Week 12- LOCF(Baseline to Week 12)
- Change From Baseline in 5-D Pruritus Scale at Week 12(Baseline to Week 12)