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

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Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 1

Conditions

Psoriasis

Treatments

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

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

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: Interferon alpha-2a recombinant
Drug: Placebo
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: BMS-986202
Drug: Famotidine
Part E: Proof of Mechanism
Experimental group
Description:
BMS-986202 or Placebo + Ustekinumab specified dose on specified days
Treatment:
Drug: BMS-986202
Drug: Ustekinumab
Drug: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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