A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp

Conditions

• Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Apremilast — DRUG
  Apremilast 30 mg tablets BID from weeks 0 to 32.
• Placebo — OTHER
  Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.

Study Details

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp. Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first 16 weeks.

Key Dates

First listed

Apr 21, 2017

Start date

May 16, 2017

Status verified

Apr 2020

Primary completion

Aug 13, 2018

Completion

Jan 9, 2019

Study Design

Enrollment

303 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Apremilast 30 mg BID
  Apremilast 30 mg tablets orally twice daily (BID) during Weeks 0 to 32
• Placebo Comparator: Placebo
  Placebo tablets BID during weeks 0 to 16; at week 16, placebo participants were switched to apremilast 30 mg tablets BID for 16 weeks (from Week 16 to Week 32)

Primary Outcome Measure

Percentage of Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From Baseline [ Time Frame: Baseline to Week 16 ]

Locations (32)

Find similar trials in Rogers, AR

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