Back to resultsSingle Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis
Primary Purpose
Healthy Volunteers, Ulcerative Colitis
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BMS-986184
Placebo matching BMS-986184
Sponsored by
About this trial
This is an interventional screening trial for Healthy Volunteers
Eligibility 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/exclusion criteria could apply
Sites / Locations
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Single Ascending Dose (SAD) - IV Panel
Single Ascending Dose (SAD) - SC Panel
Multiple Ascending Dose (MAD) - IV Panel
Proof of Mechanism (POM) - IV Panel
Arm Description
Single intravenous (IV) dose of BMS-986184 or placebo matching BMS-986184
Single subcutaneous (SC) dose of BMS-986184 or placebo matching BMS-986184
Multiple IV doses of BMS-986184 or placebo matching BMS-986184
Multiple IV doses of BMS-986184 or placebo matching BMS-986184
Outcomes
Primary Outcome Measures
Composite of safety and tolerability of BMS-986184 as assessed by vital sign measurements
Composite of safety and tolerability of BMS-986184 as assessed by physical examination findings
Composite of safety and tolerability of BMS-986184 as assessed by clinical laboratory test results
Composite of safety and tolerability of BMS-986184 as assessed by Electrocardiogram (ECG) assessments
Composite of incidence, severity and outcome of all Adverse Events (AEs)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02864264
Brief Title
Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Adverse change in the risk/benefit
Study Start Date
September 14, 2016 (Actual)
Primary Completion Date
September 27, 2017 (Actual)
Study Completion Date
September 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Ulcerative Colitis
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Ascending Dose (SAD) - IV Panel
Arm Type
Experimental
Arm Description
Single intravenous (IV) dose of BMS-986184 or placebo matching BMS-986184
Arm Title
Single Ascending Dose (SAD) - SC Panel
Arm Type
Experimental
Arm Description
Single subcutaneous (SC) dose of BMS-986184 or placebo matching BMS-986184
Arm Title
Multiple Ascending Dose (MAD) - IV Panel
Arm Type
Experimental
Arm Description
Multiple IV doses of BMS-986184 or placebo matching BMS-986184
Arm Title
Proof of Mechanism (POM) - IV Panel
Arm Type
Experimental
Arm Description
Multiple IV doses of BMS-986184 or placebo matching BMS-986184
Intervention Type
Drug
Intervention Name(s)
BMS-986184
Other Intervention Name(s)
anti - interferon gamma-induced protein 10(IP-10) antibody
Intervention Type
Drug
Intervention Name(s)
Placebo matching BMS-986184
Primary Outcome Measure Information:
Title
Composite of safety and tolerability of BMS-986184 as assessed by vital sign measurements
Time Frame
Up to 183 days
Title
Composite of safety and tolerability of BMS-986184 as assessed by physical examination findings
Time Frame
Up to 183 days
Title
Composite of safety and tolerability of BMS-986184 as assessed by clinical laboratory test results
Time Frame
Up to 183 days
Title
Composite of safety and tolerability of BMS-986184 as assessed by Electrocardiogram (ECG) assessments
Time Frame
Up to 183 days
Title
Composite of incidence, severity and outcome of all Adverse Events (AEs)
Time Frame
Up to 183 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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/exclusion criteria could apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Local Institution
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Local Institution
City
Chisinau
ZIP/Postal Code
MD-2025
Country
Moldova, Republic of
12. IPD Sharing Statement
Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis
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