Safety Study of BMS-986202 in Healthy Subjects and to Treat Psoriasis

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Psoriasis

Treatments: Drug: Ustekinumab; Drug: Interferon alpha-2a recombinant; Drug: Famotidine; Drug: BMS-986202; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02763969

IM016-006

Details and patient eligibility

About

The purpose of this study is to establish if BMS-986202 is safe and effective at treating autoimmune diseases such as psoriasis. BMS-986202 which has shown some promise in preclinical studies for inhibiting autoimmune conditions such as psoriasis. This study will be the first time this drug is given to humans.

Enrollment: 357 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Inclusion Criteria:

• Healthy Male and Female participants
• 18 to 50 years of age (Parts A-D)
• 18 to 70 years of age (Part E)
• Diagnosed with plaque psoriasis (Part E)

Exclusion Criteria:

• Participants that had recent infections
• Participants with Low Blood Pressure
• Participants with any heart related problems
• Participants with cancer
• Participants with any other major medical illness

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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357 participants in 5 patient groups

Part A: Single Ascending Dose

Experimental group

Description:

BMS-986202 or Placebo specified dose on specified days

Treatment:

Drug: BMS-986202

Drug: Placebo

Part B: Multiple Ascending Dose

Experimental group

Description:

BMS-986202 or Placebo + Interferon alpha-2a recombinant specified dose on specified days

Treatment:

Drug: BMS-986202

Drug: Placebo

Drug: Interferon alpha-2a recombinant

Part C: Multiple Ascending Dose-Japanese descent

Experimental group

Description:

BMS-986202 or Placebo specified dose on specified days in patients of Japanese descent

Treatment:

Drug: BMS-986202

Drug: Placebo

Part D: Relative Bioavailability

Experimental group

Description:

BMS-986202 (Liquid) or BMS-986202 (Capsule) + Famotidine specified dose on specified days

Treatment:

Drug: Famotidine

Drug: BMS-986202

Part E: Proof of Mechanism

Experimental group

Description:

BMS-986202 or Placebo + Ustekinumab specified dose on specified days

Treatment:

Drug: BMS-986202

Drug: Placebo

Drug: Ustekinumab