CompletedPhase 3

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

United States595 participantsStarted 2019-03-11

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subject must be male or female, ≥18 years of age at the time of signing the informed consent form (ICF).
✓. Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF.
✓. Subject must have a diagnosis of mild to moderate plaque psoriasis at both Screening and Baseline.
✓. Subject must be inadequately controlled with or intolerant of at least one topical therapy at both Screening and Baseline.
✓. Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.
✓. Subject must meet laboratory criteria.
✓. Subject has not had prior exposure to biologics for the treatment of psoriatic arthritis or psoriasis, or any other condition that could impact the assessment of psoriasis.

Exclusion criteria

✕. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
✕. Subjects has any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.

What they're measuring

Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase

Timeframe: Baseline and Week 16 of the placebo-controlled phase

Trial details

NCT IDNCT03721172

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-03-06

Results submitted2021-04-26

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