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

NCT02763969 | Completed Phase 1 DMC

• 1 other identifier: IM016-006
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 2

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (4)

• 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

  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

  4 weeks after the start of treatment

• Change from baseline in the psoriasis area

  4 weeks after the start of treatment

• Severity index (PASI) score

  4 weeks after the start of treatment

Secondary Outcomes (5)

• Effect of BMS-986202 on electrocardiographic (ECG) parameters such as heart rate in healthy subjects of any ethnic background (Parts A, B, C, D)

  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)

  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)

  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)

  Approximately 3 months

• Safety of multiple oral doses of BMS-986202 in subjects with moderate to severe psoriasis (Part E)

  Approximately 3 months

Study Arms (5)

Part A: Single Ascending Dose

EXPERIMENTAL

BMS-986202 or Placebo specified dose on specified days

Drug: BMS-986202; Drug: Placebo

Part B: Multiple Ascending Dose

EXPERIMENTAL

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

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

Part C: Multiple Ascending Dose-Japanese descent

EXPERIMENTAL

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

Drug: BMS-986202; Drug: Placebo

Part D: Relative Bioavailability

EXPERIMENTAL

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

Drug: BMS-986202; Drug: Famotidine

Part E: Proof of Mechanism

EXPERIMENTAL

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

Drug: BMS-986202; Drug: Placebo; Drug: Ustekinumab

Interventions

BMS-986202 DRUG

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

Placebo DRUG

Part A: Single Ascending Dose; Part B: Multiple Ascending Dose; Part C: Multiple Ascending Dose-Japanese descent; Part E: Proof of Mechanism

Interferon alpha-2a recombinant DRUG

Part B: Multiple Ascending Dose

Famotidine DRUG

Part D: Relative Bioavailability

Ustekinumab DRUG

Part E: Proof of Mechanism

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution

Melbourne, Victoria, 3004, Australia

Location

Local Institution

Melbourne, 3004, Australia

Location

Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

MeSH Terms

Conditions

Psoriasis

Interventions

BMS-986202; Interferon alpha-2; Famotidine; Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 5, 2016
• Study Start: May 18, 2016
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2016
• Last Updated: August 3, 2017

Record last verified: 2017-07

Locations

AU (2)