A study to see if multiple doses of REGN668 given by injections under the skin is safe to use in adult patients with moderate-to-severe atopic dermatitis when given at the same time as topical corticosteroids

• Conditions: Atopic dermatitis; MedDRA version: 14.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2012-000946-37-HU
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-23
• Last Update Posted: 4 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Male and female patients aged 18 years or older
2. Chronic Atopic Dermatitis for at least 2 years
3. Patients must be applying an additive-free, basic bland emollient twice daily for at least 7 days before the baseline visit

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 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

1. Prior treatment with REGN668
2. Hypersensitivity to corticosteroids or to any other ingredients contained by the TCS product used in the study
3. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
4. Known history of human immunodeficiency virus (HIV) infection
5. History of clinical parasite infection
6. Pregnant or breast-feeding women
7. History of alcohol or drug abuse within 2 years of the screening visit
8. Treatment with an investigational drug within 8 weeks or within 5 half-lives, if known (whichever is longer), before the baseline visit
9. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to assess the safety of repeated subcutaneous (SC) doses of REGN668 administered concomitantly with topical corticosteroids (TCS) in adult patients with moderate-to-severe atopic dermatitis (AD).;Secondary Objective: No secondary objectives have been identified for the study;Primary end point(s): The primary endpoint is the incidence and severity of adverse events (AEs).;Timepoint(s) of evaluation of this end point: Throughout the duration of the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): No secondary end points have been identified for the study;Timepoint(s) of evaluation of this end point: No secondary end points have been identified for the study