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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763969
• Other study ID #: IM016-006
• Status: Completed
• Phase: Phase 1
• First received: May 4, 2016
• Last updated: August 2, 2017
• Start date: May 18, 2016
• Est. completion date: December 15, 2016

Study information

• Verified date: July 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: December 15, 2016
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• BMS-986202

• Placebo

• Interferon alpha-2a recombinant

• Famotidine

• Ustekinumab

Locations

Country	Name	City	State
Australia	Local Institution	Melbourne	Victoria
Australia	Local Institution	Melbourne

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change from baseline in the psoriasis area		4 weeks after the start of treatment
Primary	Severity index (PASI) score		4 weeks after the start of treatment
Secondary	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
Secondary	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)	Approximately 3 months
Secondary	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)	Approximately 3 months
Secondary	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)	Approximately 3 months
Secondary	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	Approximately 3 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form