Clinical trial NCT02763969: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-05-05
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: 4 weeks after the start of treatment
measure: 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
timeFrame: 4 weeks after the start of treatment
measure: Change from baseline in the psoriasis area
timeFrame: 4 weeks after the start of treatment
measure: Severity index (PASI) score
timeFrame: 4 weeks after the start of treatment
Secondary outcomes:
measure: Effect of BMS-986202 on electrocardiographic (ECG) parameters such as heart rate in healthy subjects of any ethnic background (Parts A, B, C, D)
timeFrame: Approximately 3 months
measure: Effect of BMS-986202 on electrocardiographic (ECG) parameters such as PR interval in healthy subjects of any ethnic background (Parts A, B, C, D)
timeFrame: Approximately 3 months
measure: Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QRS interval in healthy subjects of any ethnic background (Parts A, B, C, D)
timeFrame: Approximately 3 months
measure: Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QTc interval in healthy subjects of any ethnic background (Parts A, B, C, D)
timeFrame: Approximately 3 months
measure: Safety of multiple oral doses of BMS-986202 in subjects with moderate to severe psoriasis (Part E)
timeFrame: Approximately 3 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: