Healthy VolunteersPhase 1NCT02864264
Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis
A Phase 1 study testing BMS-986184 in people with Healthy Volunteers and Ulcerative Colitis, run by Bristol-Myers Squibb at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Ulcerative Colitis
- What is being tested?
- BMS-986184
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 14 Sep 2016to 27 Sep 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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
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
- Healthy Volunteers, Ulcerative Colitis
- Being tested
- BMS-986184, Placebo matching BMS-986184
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986184Drug
Also called anti - interferon gamma-induced protein 10(IP-10) antibody
Placebo matching BMS-986184Drug
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose (SAD) - IV Panel | Experimental | Single intravenous (IV) dose of BMS-986184 or placebo matching BMS-986184 Receives: Drug: BMS-986184; Drug: Placebo matching BMS-986184 |
| Single Ascending Dose (SAD) - SC Panel | Experimental | Single subcutaneous (SC) dose of BMS-986184 or placebo matching BMS-986184 Receives: Drug: BMS-986184; Drug: Placebo matching BMS-986184 |
| Multiple Ascending Dose (MAD) - IV Panel | Experimental | Multiple IV doses of BMS-986184 or placebo matching BMS-986184 Receives: Drug: BMS-986184; Drug: Placebo matching BMS-986184 |
| Proof of Mechanism (POM) - IV Panel | Experimental | Multiple IV doses of BMS-986184 or placebo matching BMS-986184 Receives: Drug: BMS-986184; Drug: Placebo matching BMS-986184 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of safety and tolerability of BMS-986184 as assessed by vital sign measurements
Measured: Up to 183 days
Composite of safety and tolerability of BMS-986184 as assessed by physical examination findings
Measured: Up to 183 days
Composite of safety and tolerability of BMS-986184 as assessed by clinical laboratory test results
Measured: Up to 183 days
Composite of safety and tolerability of BMS-986184 as assessed by Electrocardiogram (ECG) assessments
Measured: Up to 183 days
Composite of incidence, severity and outcome of all Adverse Events (AEs)
Measured: Up to 183 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start14 Sep 2016
- Primary completion27 Sep 2017
- Study completion27 Sep 2017
Why it stopped: Adverse change in the risk/benefit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864264
- Sponsor's protocol ID
- IM012-004
- Other IDs
- 2016-000895-72, 2016
- Status last verified
- Oct 2017
- First submitted
- 9 Aug 2016
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02864264
- Acronym / sponsor ID
- IM012-004
- Conditions
- Healthy Volunteers, Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adverse change in the risk/benefit
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2016 (actual)
- Primary completion
- 27 Sep 2017 (actual)
- Study completion
- 27 Sep 2017 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (SAD) - IV Panel | Experimental | Drug: BMS-986184, Drug: Placebo matching BMS-986184Single intravenous (IV) dose of BMS-986184 or placebo matching BMS-986184 |
| Single Ascending Dose (SAD) - SC Panel | Experimental | Drug: BMS-986184, Drug: Placebo matching BMS-986184Single subcutaneous (SC) dose of BMS-986184 or placebo matching BMS-986184 |
| Multiple Ascending Dose (MAD) - IV Panel | Experimental | Drug: BMS-986184, Drug: Placebo matching BMS-986184Multiple IV doses of BMS-986184 or placebo matching BMS-986184 |
| Proof of Mechanism (POM) - IV Panel | Experimental | Drug: BMS-986184, Drug: Placebo matching BMS-986184Multiple IV doses of BMS-986184 or placebo matching BMS-986184 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986184Also: anti - interferon gamma-induced protein 10(IP-10) antibody | Drug | Multiple Ascending Dose (MAD) - IV Panel, Proof of Mechanism (POM) - IV Panel, Single Ascending Dose (SAD) - IV Panel, Single Ascending Dose (SAD) - SC Panel |
| Placebo matching BMS-986184 | Drug | Multiple Ascending Dose (MAD) - IV Panel, Proof of Mechanism (POM) - IV Panel, Single Ascending Dose (SAD) - IV Panel, Single Ascending Dose (SAD) - SC Panel |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Adverse change in the risk/benefit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986184 in people with Healthy Volunteers and Ulcerative Colitis, run by Bristol-Myers Squibb at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Georgia, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Adverse change in the risk/benefit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of safety and tolerability of BMS-986184 as assessed by vital sign measurements (time frame: Up to 183 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.