Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)

Conditions

• Plaque-type Psoriasis
• Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Apremilast 10mg — DRUG
• Apremilast 20mg — DRUG
• Apremilast 30 mg — DRUG
• Placebo — DRUG
• Apremilast 30mg — DRUG
• Apremilast 20mg — DRUG

Study Details

The purpose of this study was to test if the drug apremilast was safe, if it helped improve psoriasis, and how well the participants tolerated it.

Key Dates

First listed

Oct 16, 2008

Start date

Sep 1, 2008

Status verified

Apr 2020

Primary completion

Aug 1, 2009

Completion

May 20, 2015

Study Design

Enrollment

352 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Apremilast 10mg
  Apremilast 10 mg administered orally twice daily (BID) for 16 weeks (following dose titration) during the placebo controlled phase followed by 10 mg Apremilast tablets orally administered BID for 8 weeks in the active treatment phase
• Experimental: Apremilast 20mg
  Apremilast 20 mg administered orally twice daily (BID) for 16 weeks (following dose titration) during the placebo controlled phase followed by 20 mg Apremilast tablets orally administered BID for 8 weeks in the active treatment phase
• Experimental: Apremilast 30 mg
  Apremilast 30 mg administered orally twice daily (BID) for 16 weeks (following dose titration) during the placebo controlled phase followed by 30 mg Apremilast tablets orally administered BID for 8 weeks in the active treatment phase
• Placebo Comparator: Placebo
  Oral Placebo tablets administered twice daily (BID) for 16 weeks during the placebo-controlled phase.
• Experimental: Placebo/Apremilast 20 mg
  Participants initially randomized to receive placebo twice daily during the 16 week placebo controlled phase are re-randomized to 20 mg apremilast BID during the 8 week active treatment phase
• Experimental: Placebo/Apremilast 30mg
  Participants initially randomized to receive placebo twice daily during the 16 week placebo controlled phase are re-randomized to 30 mg apremilast BID during the 8 week active treatment phase

Primary Outcome Measure

Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in Psoriasis Area and Severity Index (PASI) at Week 16 [ Time Frame: Week 0 and Week 16 ]

Locations (20)

Find similar trials in Fresno, CA

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