Overview

This trial is active, not recruiting.

Condition atopic dermatitis
Treatments dupilumab, placebo
Phase phase 3
Sponsor Regeneron Pharmaceuticals
Collaborator Sanofi
Start date March 2015
End date July 2016
Trial size 475 participants
Trial identifier NCT02395133, 2014-003384-38, R668-AD-1415

Summary

The primary objective of the study is to assess the ability of different dupilumab dose regimens, administered as monotherapy, to maintain the treatment response achieved after 16 weeks of initial treatment with dupilumab monotherapy compared to placebo.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants who received treatment regimen 1 of SC dupilumab in the initial treatment studies will be randomized to group 1 and receive 1 of 4 treatment regimens
dupilumab REGN668/SAR231893
placebo
(Experimental)
Participants who received treatment regimen 2 of SC dupilumab in the initial treatment studies will be randomized to group 2 and receive 1 of 4 treatment regimens
dupilumab REGN668/SAR231893
placebo

Primary Outcomes

Measure
Proportion of patients with Investigator's Global Assessment (IGA) scores of 0 or 1 (clear or almost clear) at week 36
time frame: At week 36

Secondary Outcomes

Measure
Proportion of participants with EASI-75 (Eczema Area and Severity Index ≥75%) improvement) at week 36 compared to the baseline EASI in the initial treatment study [NCT02277743 (R668-AD-1334) or NCT02277769 (R668-AD-1416)]
time frame: At week 36
Percent of patients whose Pruritus NRS increased by 3 or more points from baseline to week 36
time frame: Baseline to week 36

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria: 1. Must have completed the treatment phase in 1 of the two 16-week initial treatment studies (R668-AD-1334 or R668-AD-1416). 2. Must have achieved at least 1 of the following 2 treatment success criteria: IGA = 0 or 1 (clear or almost clear) at week 16 OR EASI-75 (at least 75% reduction in EASI score from baseline to week 16) 3. Must be willing and able to comply with clinic visits and study-related procedures 4. Must provide signed informed consent 5. Must be able to understand and complete study-related questionnaires Key Exclusion Criteria: 1. Receipt of rescue medication for AD in the initial treatment study 2. Any conditions that require permanent discontinuation of study treatment in either initial treatment study 3. Planned or anticipated major surgical procedure during the patient's participation in this study 4. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during this study

Additional Information

Official title A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of Multiple Dupilumab Dose Regimens Administered as Monotherapy for Maintaining Treatment Response in Patients With Atopic Dermatitis
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Regeneron Pharmaceuticals.