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

August 2, 2017 updated by: Bristol-Myers Squibb

Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986202 in Healthy Subjects and to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of BMS-986202 in Subjects With Moderate to Severe Psoriasis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

357

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia, 3004
        • Local Institution
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Single Ascending Dose
BMS-986202 or Placebo specified dose on specified days
Drug: Placebo
Drug: BMS-986202
Experimental: Part B: Multiple Ascending Dose
BMS-986202 or Placebo + Interferon alpha-2a recombinant specified dose on specified days
Drug: Placebo
Drug: Interferon alpha-2a recombinant
Drug: BMS-986202
Experimental: Part C: Multiple Ascending Dose-Japanese descent
BMS-986202 or Placebo specified dose on specified days in patients of Japanese descent
Drug: Placebo
Drug: BMS-986202
Experimental: Part D: Relative Bioavailability
BMS-986202 (Liquid) or BMS-986202 (Capsule) + Famotidine specified dose on specified days
Drug: Famotidine
Drug: BMS-986202
Experimental: Part E: Proof of Mechanism
BMS-986202 or Placebo + Ustekinumab specified dose on specified days
Drug: Placebo
Drug: Ustekinumab
Drug: BMS-986202

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of a single oral dose of BMS-986202 based on number of incidence of AEs, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Time Frame: 4 weeks after the start of treatment
4 weeks after the start of treatment
Safety of a multiple oral dose of BMS-986202 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Time Frame: 4 weeks after the start of treatment
4 weeks after the start of treatment
Change from baseline in the psoriasis area
Time Frame: 4 weeks after the start of treatment
4 weeks after the start of treatment
Severity index (PASI) score
Time Frame: 4 weeks after the start of treatment
4 weeks after the start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as heart rate in healthy subjects of any ethnic background (Parts A, B, C, D)
Time Frame: Approximately 3 months
Approximately 3 months
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as PR interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Time Frame: Approximately 3 months
The interval from the beginning of the P wave to the beginning of the QRS complex (PR interval)
Approximately 3 months
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QRS interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Time Frame: Approximately 3 months
The interval from the beginning of the Q wave and the end of the S wave (QRS interval)
Approximately 3 months
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QTc interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Time Frame: Approximately 3 months

The interval from the beginning of the Q wave to the end of the T wave (QT interval).

The QT interval corrected for heart rate (QTc interval)
Approximately 3 months
Safety of multiple oral doses of BMS-986202 in subjects with moderate to severe psoriasis (Part E)
Time Frame: Approximately 3 months
Safety of multiple oral doses of BMS-986202 in subjects with moderate to severe psoriasis (Part E) based on number of incidence of adverse events(AEs), serious adverse events(SAEs), AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Approximately 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2016

Primary Completion (Actual)

December 15, 2016

Study Completion (Actual)

December 15, 2016

Study Registration Dates

First Submitted

May 4, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Actual)

August 3, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM016-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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