A Study to Confirm the Efficacy and Safety of Different Dupilumab Dose Regimens in Adults With Atopic Dermatitis (AD)
This trial is active, not recruiting.
|Start date||March 2015|
|End date||July 2016|
|Trial size||475 participants|
|Trial identifier||NCT02395133, 2014-003384-38, R668-AD-1415|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
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
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
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
|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|
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