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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
BMS-986202
Placebo
Interferon alpha-2a recombinant
Famotidine
Ustekinumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Part A: Single Ascending Dose

Part B: Multiple Ascending Dose

Part C: Multiple Ascending Dose-Japanese descent

Part D: Relative Bioavailability

Part E: Proof of Mechanism

Arm Description

BMS-986202 or Placebo specified dose on specified days

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

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

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

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

Outcomes

Primary Outcome Measures

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
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
Change from baseline in the psoriasis area
Severity index (PASI) score

Secondary Outcome Measures

Effect of BMS-986202 on electrocardiographic (ECG) parameters such as heart rate in healthy subjects of any ethnic background (Parts A, B, C, D)
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as PR interval in healthy subjects of any ethnic background (Parts A, B, C, D)
The interval from the beginning of the P wave to the beginning of the QRS complex (PR interval)
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QRS interval in healthy subjects of any ethnic background (Parts A, B, C, D)
The interval from the beginning of the Q wave and the end of the S wave (QRS interval)
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QTc interval in healthy subjects of any ethnic background (Parts A, B, C, D)
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)
Safety of multiple oral doses of BMS-986202 in subjects with moderate to severe psoriasis (Part E)
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

Full Information

First Posted
May 4, 2016
Last Updated
August 2, 2017
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02763969
Brief Title
Safety Study of BMS-986202 in Healthy Subjects and to Treat Psoriasis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 18, 2016 (Actual)
Primary Completion Date
December 15, 2016 (Actual)
Study Completion Date
December 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
357 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: Single Ascending Dose
Arm Type
Experimental
Arm Description
BMS-986202 or Placebo specified dose on specified days
Arm Title
Part B: Multiple Ascending Dose
Arm Type
Experimental
Arm Description
BMS-986202 or Placebo + Interferon alpha-2a recombinant specified dose on specified days
Arm Title
Part C: Multiple Ascending Dose-Japanese descent
Arm Type
Experimental
Arm Description
BMS-986202 or Placebo specified dose on specified days in patients of Japanese descent
Arm Title
Part D: Relative Bioavailability
Arm Type
Experimental
Arm Description
BMS-986202 (Liquid) or BMS-986202 (Capsule) + Famotidine specified dose on specified days
Arm Title
Part E: Proof of Mechanism
Arm Type
Experimental
Arm Description
BMS-986202 or Placebo + Ustekinumab specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
BMS-986202
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Interferon alpha-2a recombinant
Intervention Type
Drug
Intervention Name(s)
Famotidine
Intervention Type
Drug
Intervention Name(s)
Ustekinumab
Primary Outcome Measure Information:
Title
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
Title
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
Title
Change from baseline in the psoriasis area
Time Frame
4 weeks after the start of treatment
Title
Severity index (PASI) score
Time Frame
4 weeks after the start of treatment
Secondary Outcome Measure Information:
Title
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
Title
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as PR interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Description
The interval from the beginning of the P wave to the beginning of the QRS complex (PR interval)
Time Frame
Approximately 3 months
Title
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QRS interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Description
The interval from the beginning of the Q wave and the end of the S wave (QRS interval)
Time Frame
Approximately 3 months
Title
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QTc interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Description
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)
Time Frame
Approximately 3 months
Title
Safety of multiple oral doses of BMS-986202 in subjects with moderate to severe psoriasis (Part E)
Description
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
Time Frame
Approximately 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Local Institution
City
Melbourne
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

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

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