Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy

Conditions

• Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Apremilast — DRUG
  Apremilast, oral, twice daily
• Placebo — OTHER
  Placebo, oral, twice daily

Study Details

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis. Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.

Key Dates

First listed

Oct 26, 2018

Start date

Mar 11, 2019

Status verified

May 2024

Primary completion

Mar 6, 2020

Completion

Jul 24, 2020

Study Design

Enrollment

595 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Placebo-controlled Phase:
  Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16).
• Experimental: Placebo-controlled Phase: Apremilast 30 mg
  Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
• Experimental: Extension Phase: Apremilast 30 mg
  Eligible participants who completed the placebocontrolled phase entered the extension phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).

Primary Outcome Measure

Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase [ Time Frame: Baseline and Week 16 of the placebo-controlled phase ]

Locations (43)

Find similar trials in Birmingham, AL

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