Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

A study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe atopic dermatitis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen; Celgene Corporation
• Treatments: Apremilast; Thalidomide

Criteria

Inclusion Criteria:

1. Males or females, aged ≥ 18 years (≥ 20 for Japanese subjects) at the time of consent.

2. Have a diagnosis of atopic dermatitis for ≥ 12 months.

3. Have moderate to severe atopic dermatitis which is considered inappropriate for topical therapy or which cannot be adequately controlled by topical therapy.

4. Meet the laboratory criteria as defined per protocol

5. Females of Childbearing Potential (FCBP) must have a negative pregnancy test at Screening and Baseline. Sexually active FCBP must use one of the approved contraceptive options required per protocol while on and for at least 28 days after the last dose of study medication

6. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception while on and for at least 28 days after the last dose of study medication.

Exclusion Criteria:

1. Active tuberculosis (TB) or a history of inadequately treated tuberculosis.

2. Positive for hepatitis B surface antigen or hepatitis C antibody

3. Pregnant or breast feeding

4. History of allergy to any component of the study medication.

5. Active skin infection requiring systemic antimicrobials at Baseline.