TerminatedNCT02864264Updated Oct 20, 2017

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

A Phase 1 interventional study of BMS-986184 and Placebo matching BMS-986184 in Healthy Volunteers and Ulcerative Colitis, sponsored by Bristol-Myers Squibb. Terminated at 3 sites in 3 countries. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-20.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Screening

Why this study was terminated

Adverse change in the risk/benefit

From the registry’s dates

Primary completion was Sep 2017, 9 years ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 7
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Conditions studied

Healthy Volunteers
Ulcerative Colitis

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In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 7 is below the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

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

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/exclusion criteria could apply

Study design

Phase: Phase 1
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 7 participants (actual)

Study arms

Experimental
Single Ascending Dose (SAD) - IV Panel
Single intravenous (IV) dose of BMS-986184 or placebo matching BMS-986184
Drug: BMS-986184 · Drug: Placebo matching BMS-986184
Experimental
Single Ascending Dose (SAD) - SC Panel
Single subcutaneous (SC) dose of BMS-986184 or placebo matching BMS-986184
Drug: BMS-986184 · Drug: Placebo matching BMS-986184
Experimental
Multiple Ascending Dose (MAD) - IV Panel
Multiple IV doses of BMS-986184 or placebo matching BMS-986184
Drug: BMS-986184 · Drug: Placebo matching BMS-986184
Experimental
Proof of Mechanism (POM) - IV Panel
Multiple IV doses of BMS-986184 or placebo matching BMS-986184
Drug: BMS-986184 · Drug: Placebo matching BMS-986184

Interventions

DrugBMS-986184
Also known as: anti - interferon gamma-induced protein 10(IP-10) antibody
DrugPlacebo matching BMS-986184

What researchers measure

Primary outcomes

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

Study locations

3 sites

Local Institution
Melbourne, Victoria 3004, Australia
Local Institution
Tbilisi, 0112, Georgia
Local Institution
Chisinau, MD-2025, Moldova, Republic of

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02864264
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Aug 11, 2016
Start date: Sep 14, 2016
Primary completion: Sep 27, 2017
Completion: Sep 27, 2017
Last update: Oct 20, 2017

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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