A study to confirm the efficacy and safety of different dupilumab dose regimens in adults with atopic dermatitis (AD)

Phase 1

Active, not recruiting

• Conditions: Atopic dermatitis; MedDRA version: 19.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-003384-38-BG
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-01
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 475

Inclusion Criteria

A patient must meet the following criteria to be eligible for inclusion in the study:
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
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 428
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 47

Exclusion Criteria

A patient who meets any of the following criteria will be excluded from the study:
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

Birth control exclusion criterion # 5is listed in protocol section 4.2.2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified