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

Amgen

Status and phase: Completed; Phase 2

Conditions: Dermatitis, Atopic Dermatitis

Treatments: Drug: Placebo; Drug: Apremilast

Study type: Interventional

Funder types: Industry

Identifiers

NCT02087943

CC-10004-AD-001

Details and patient eligibility

About

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

Enrollment: 191 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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191 participants in 5 patient groups, including a placebo group

Apremilast 40 mg

Experimental group

Description:

Apremilast 40 mg administered orally twice daily (BID) for 12 weeks (following dose titration) during the placebo controlled phase followed by 40 mg Apremilast tablets orally administered BID for an additional 12 weeks in the active treatment phase

Treatment:

Drug: Apremilast

Drug: Apremilast

Apremilast 30 mg

Experimental group

Description:

Apremilast 30 mg administered orally BID for 12 weeks (following dose titration) during the placebo controlled phase followed by 30 mg Apremilast tablets orally administered BID for an additional 12 weeks in the active treatment phase

Treatment:

Drug: Apremilast

Drug: Apremilast

Placebo + Apremilast 40 mg

Experimental group

Description:

Placebo administered orally BID for 12 weeks, during the placebo controlled phase followed by 40 mg Apremilast tablets orally BID for an additional 12 weeks in the active treatment phase

Treatment:

Drug: Apremilast

Drug: Placebo

Drug: Placebo

Drug: Apremilast

Placebo + Apremilast 30 mg

Experimental group

Description:

Placebo administered orally BID for 12 weeks, during the placebo controlled phase followed by 30 mg Apremilast tablets orally BID for an additional 12 weeks in the active treatment phase

Treatment:

Drug: Apremilast

Drug: Placebo

Drug: Placebo

Drug: Apremilast

Placebo

Placebo Comparator group

Description:

Oral Placebo tablets administered twice daily (BID) for 12 weeks during the placebo-controlled phase.

Treatment:

Drug: Placebo

Drug: Placebo