A Phase 3B, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy

Sponsor
Amgen
Study ID
NCT03930186
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apremilast — DRUG
    Tablets for oral administration
  • Topical Therapy — DRUG
    Participants continued to use their existing topical treatment for psoriasis for the first 16 weeks. After 16 weeks, participants could decrease the use of topical therapy at their discretion under the direction of their physician.

Study Details

The primary objective of the study is to assess the efficacy and safety of the combination of apremilast plus topical therapies for the treatment of adults with plaque psoriasis who have not achieved an adequate response with topicals alone.

Key Dates

First listed
Apr 29, 2019
Start date
Jun 17, 2019
Status verified
Dec 2021
Primary completion
May 8, 2020
Completion
Sep 25, 2020

Study Design

Enrollment
152 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apremilast
    After a 5-day titration, participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16 participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.

Primary Outcome Measure

Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 16 [ Time Frame: Week 16 ]

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