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

Conditions

• Dermatitis, Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Apremilast — DRUG
  Orally twice a day (BID)
• Apremilast — DRUG
  Orally twice a day (BID)
• Placebo — DRUG
  Orally twice a day (BID)
• Placebo — DRUG
  Orally twice a day (BID)

Study Details

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

Key Dates

First listed

Mar 14, 2014

Start date

Jun 30, 2014

Status verified

Apr 2017

Primary completion

Oct 31, 2015

Completion

Feb 29, 2016

Study Design

Enrollment

191 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Apremilast 40 mg
  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
• Experimental: Apremilast 30 mg
  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
• Experimental: Placebo + Apremilast 40 mg
  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
• Experimental: Placebo + Apremilast 30 mg
  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
• Placebo Comparator: Placebo
  Oral Placebo tablets administered twice daily (BID) for 12 weeks during the placebo-controlled phase.

Primary Outcome Measure

Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12. [ Time Frame: Baseline to Week 12 ]

Locations (15)

Find similar trials in Phoenix, AZ