A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis.

Conditions

• Parapsoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Apremilast — DRUG
  Apremilast 30 mg tablets orally twice daily (BID) weeks 0 to 52.
• Placebo — DRUG
  Participants randomized to the placebo treatment group received placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally BID for from weeks 0-16.
• Placebo-Apremilast — DRUG
  At Week 16, those randomized to placebo were switched to apremilast 30mg BID for an additional 36 weeks (52 weeks total)

Study Details

This study will evaluate the clinical efficacy, the patients quality of life, and safety of oral apremilast 30 mg twice daily (BID) compared to placebo, in adult patients with moderate plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year in the Extension Phase of the trial.

Key Dates

First listed

Apr 24, 2015

Start date

Apr 20, 2015

Status verified

Apr 2020

Primary completion

Feb 12, 2016

Completion

Nov 22, 2016

Study Design

Enrollment

221 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Apremilast
  Apremilast 30 mg tablets orally twice daily (BID) weeks 0 to 52.
• 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 36 weeks (from week 16 to week 52)

Primary Outcome Measure

Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16 [ Time Frame: Baseline to Week 16 (end of phase) ]

Locations (26)

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