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Completed

NCT Number: NCT02763969

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

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986202

Drug

Placebo

Drug

Interferon alpha-2a recombinant

Drug

Famotidine

Drug

Ustekinumab

Drug

Primary outcomes

  1. 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

  2. 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

  3. Change from baseline in the psoriasis area

    Time frame: 4 weeks after the start of treatment

  4. Severity index (PASI) score

    Time frame: 4 weeks after the start of treatment

Secondary outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 5, 2016
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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