Conditions: Dermatitis, Atopic Dermatitis
Keywords: Atopic Dermatitis Atopic Eczema
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 191
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: 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 arm 2: 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 arm 3: 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 arm 4: 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 arm 5: Oral Placebo tablets administered twice daily (BID) for 12 weeks during the placebo-controlled phase.

Interventions: intervention 1: Apremilast intervention 2: Apremilast intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: Orally twice a day (BID) intervention 2: Orally twice a day (BID) intervention 3: Orally twice a day (BID) intervention 4: Orally twice a day (BID)

Protocol document: