Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis

Double-Blind, Randomized, Placebo-Controlled, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Target Engagement of BMS-986184 in Healthy Subjects and to Evaluate the Safety, Efficacy, Pharmacokinetics, Target Engagement, and Pharmacodynamics of BMS-986184 in Patients With Moderate to Severe Ulcerative Colitis

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02864264

Enrollment

Registered

2016-08-11

Start date

2016-09-14

Completion date

2017-09-27

Last updated

2017-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers, Ulcerative Colitis

Brief summary

The primary purpose of this study is to determine if single and multiple doses of BMS-986184 are safe and well tolerated in healthy male and female subjects. The primary purpose of the proof of mechanism study is to determine safety and efficacy in patients with ulcerative colitis.

Interventions

DRUGBMS-986184

DRUGPlacebo matching BMS-986184

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Women of childbearing potential must have a negative serum pregnancy test within 24 hours prior to the start of study drug * Diagnosis of ulcerative colitis confirmed by endoscopic and histologic evidence (if no previous confirmation of diagnosis is available or if diagnosis is not conclusive, at time of baseline endoscopy, histology must be performed and read locally to confirm diagnosis)

Exclusion criteria

* Any bacterial, fungal or viral infection, including tuberculosis, HIV, hepatitis B or hepatitis C * Subjects with history of cancer, lymphoproliferative disease, class III or IV congestive heart failure, myocardial infarction, unstable angina pectoris, or any history of significant ocular disease such as glaucoma or retinal disease Other protocol defined inclusion/

Design outcomes

Primary

Measure	Time frame
Composite of safety and tolerability of BMS-986184 as assessed by vital sign measurements	Up to 183 days
Composite of safety and tolerability of BMS-986184 as assessed by physical examination findings	Up to 183 days
Composite of safety and tolerability of BMS-986184 as assessed by clinical laboratory test results	Up to 183 days
Composite of safety and tolerability of BMS-986184 as assessed by Electrocardiogram (ECG) assessments	Up to 183 days
Composite of incidence, severity and outcome of all Adverse Events (AEs)	Up to 183 days

Countries

Australia, Georgia, Moldova

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026