Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis (POETYK-PSO-1)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Other: Placebo; Drug: Apremilast; Drug: BMS-986165

Study type: Interventional

Funder types: Industry

Identifiers

NCT03624127

2018-001926-25 (EudraCT Number)

IM011-046

Details and patient eligibility

About

The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.

Enrollment: 666 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Plaque psoriasis for at least 6 months
• Moderate to severe disease
• Candidate for phototherapy or systemic therapy

Exclusion Criteria:

• Other forms of psoriasis
• History of recent infection
• Prior exposure to BMS-986165 or active comparator

Other protocol defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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666 participants in 3 patient groups, including a placebo group

BMS-986165

Experimental group

Treatment:

Drug: BMS-986165

Placebo

Placebo Comparator group

Treatment:

Other: Placebo

Apremilast

Active Comparator group

Treatment:

Drug: Apremilast