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

NCT ID: NCT02763969

Last Updated: 2017-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

357 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-18

Study Completion Date

2016-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A: Single Ascending Dose

BMS-986202 or Placebo specified dose on specified days

Group Type EXPERIMENTAL

BMS-986202

Intervention Type DRUG

Placebo

Intervention Type DRUG

Part B: Multiple Ascending Dose

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

Group Type EXPERIMENTAL

BMS-986202

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interferon alpha-2a recombinant

Intervention Type DRUG

Part C: Multiple Ascending Dose-Japanese descent

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

Group Type EXPERIMENTAL

BMS-986202

Intervention Type DRUG

Placebo

Intervention Type DRUG

Part D: Relative Bioavailability

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

Group Type EXPERIMENTAL

BMS-986202

Intervention Type DRUG

Famotidine

Intervention Type DRUG

Part E: Proof of Mechanism

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

Group Type EXPERIMENTAL

BMS-986202

Intervention Type DRUG

Placebo

Intervention Type DRUG

Ustekinumab

Intervention Type DRUG

Interventions

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BMS-986202

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interferon alpha-2a recombinant

Intervention Type DRUG

Famotidine

Intervention Type DRUG

Ustekinumab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Melbourne, Victoria, Australia

Site Status

Local Institution

Melbourne, , Australia

Site Status

Countries

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Australia

Related Links

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http://bms.com/studyconnect/Pages/home.aspx

BMS Clinical Trial Patient Recruiting

http://www.bms.com/clinical_trials/Pages/Investigator_inquiry_form.aspx

Investigator Inquiry Form

Other Identifiers

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IM016-006

Identifier Type: -

Identifier Source: org_study_id

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