An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis (POETYK-PSO-2)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Psoriasis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03611751

IM011-047

2018-001925-24 (EudraCT Number)

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: 1,020 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 could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,020 participants in 3 patient groups, including a placebo group

BMS-986165

Experimental group

Description:

BMS-986165 oral administration

Treatment:

Drug: BMS-986165

Placebo

Placebo Comparator group

Description:

Placebo oral administration

Treatment:

Other: Placebo

Active comparator

Active Comparator group

Description:

Active comparator oral administration

Treatment:

Drug: Apremilast