Colitis, UlcerativePhase 2NCT04613518
A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis
A Phase 2 study testing BMS-986165 in people with Colitis, Ulcerative, run by Bristol-Myers Squibb at 26 sites in 8 countries.
Trial summary
The purpose of this study is to assess the safety and tolerability, efficacy, and biomarker response of BMS-986165 administered orally in participants with moderate to severe ulcerative colitis. The study was originally designed to test deucravacitinib at two doses for 12 weeks compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- BMS-986165
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 26 sitesin 8 countries
- Study dates
- 15 Mar 2021to 29 Nov 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of ulcerative colitis (UC) at least 3 months' duration prior to screening
- Moderately to severely active UC as assessed by the modified Mayo score
- Documentation of an inadequate response, loss of response, or intolerance to a treatment course of 1 or more of the following standard of care medications: oral 5-aminosalicylic acids, corticosteroids, immunomodulators, anti-tumor necrosis factor (TNF) agents, integrin inhibitors[SA1]
- Documentation of prior treatment with corticosteroids for ≥ 4 weeks
- Males and females must agree to follow specific methods of contraception, if applicable
Who cannot join
- Current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC), ischemic colitis, or pseudomembranous colitis
- Current evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation
- History or evidence of any extensive colonic resection, or subtotal or total colectomy
- Women who are pregnant or breastfeeding
- Prior exposure to BMS-986165 or a tyrosine kinase 2 (TYK2) inhibitor
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
26 sites in 8 countries.
26 sites in 8 countries
United States10 sites
Local Institution - 0036
Arlington Heights, Illinois, 60005
Local Institution - 0026
Chapel Hill, North Carolina, 27599-7080
Local Institution - 0013
Cleveland, Ohio, 44195
Local Institution - 0032
Garland, Texas, 75044
Local Institution - 0039
Lubbock, Texas, 74910
Local Institution - 0015
New York, New York, 10029
Local Institution - 0020
Oklahoma City, Oklahoma, 73112
Local Institution - 0014
San Diego, California, 92123
Local Institution - 0016
Shreveport, Louisiana, 71105
Local Institution - 0033
Southlake, Texas, 76092
Poland4 sites
Local Institution - 0029
Bydgoszcz, 85-231
Local Institution - 0028
Bydgoszcz, 85-794
Local Institution - 0031
Warsaw, Masovian Voivodeship, 02-798
Local Institution - 0030
Warsaw, Masovian Voivodeship, 04-501
Canada3 sites
Local Institution - 0007
Edmonton, Alberta, T6K4B2
Local Institution - 0025
London, Ontario, N6A 5A5
Local Institution - 0008
Vaughan, Ontario, L4L 4Y7
Germany3 sites
Local Institution - 0003
Berlin, 12200
Local Institution - 0019
Dresden, 01307
Local Institution - 0006
Kiel, 24105
Australia2 sites
Local Institution - 0002
Camberwell, Victoria, 3142
Local Institution - 0005
Sydney, New South Wales, 2010
United Kingdom2 sites
Local Institution - 0027
Cambridge, CB2 0QQ
Local Institution - 0023
London, England, E11 1NR
Netherlands1 site
Local Institution - 0009
Amsterdam, North Holland, 1081 HZ
About this study
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis
The purpose of this study is to assess the safety and tolerability, efficacy, and biomarker response of BMS-986165 administered orally in participants with moderate to severe ulcerative colitis. The study was originally designed to test deucravacitinib at two doses for 12 weeks compared to placebo. After the initial 12-Week period, all subjects receive active therapy (open-label extension). With protocol amendment 2, one of the dose treatment arms is being removed from the 12-week double blind period with no change to the open-label extension.
- Conditions
- Colitis, Ulcerative
- Being tested
- BMS-986165, Placebo Comparator
- 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-986165Drug
Specified Dose on Specified Days
Placebo ComparatorOther
Specified Dose on Specified Days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986165 | Experimental | Not described Receives: Drug: BMS-986165 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo Comparator |
| Open label Extension, BMS-986165 | Experimental | Not described Receives: Drug: BMS-986165 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants in Clinical Response at Week 12
Clinical response is defined as achieving the following changes in the modified Mayo score (excludes the physicians' global assessment)
- A decrease from baseline in the modified Mayo score of ≥ 2 points, and
- A decrease from baseline in the modified Mayo score ≥ 30%, and
- A decrease in rectal bleeding (RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1
Note: The modified Mayo score calculated to determine eligibility will also be used as the baseline disease activity score.
The modified Mayo score is a 9-point scale (a score of 5 to 9 points denotes moderate to severe disease). The modified Mayo score is a sum of the following 3 components:
- Stool frequency (SF) subscore (0 to 3)
- Rectal bleeding (RB) subscore (0 to 3)
- Endoscopic (ES) subscore (0 to 3)
Measured: At week 12
Number of Participants Experiencing Adverse Events (AEs)
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.
Measured: From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)
Number of Participants Experiencing Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.
Measured: From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.
Measured: From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)
Number of Participants Experiencing Adverse Events of Special Interest (AEIs)
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. AEs of special interest include: skin events, influenza, herpes viral infections, opportunistic infections, tuberculosis, cardiovascular events, malignancy, and COVID-19.
Measured: From first dose to 52 weeks after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start15 Mar 2021
- Primary completion31 May 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colitis, UlcerativeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 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
- NCT04613518
- Sponsor's protocol ID
- IM011-127
- Other IDs
- 2019-004878-26, U1111-1245-2970, 2019
- Status last verified
- Jul 2024
- First submitted
- 28 Oct 2020
- Last updated
- 12 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Shin E, Bhat AG, Ramanathan M. Large Language Models for Clinical Trial Protocol Assessments. Clin Pharmacol Ther. 2026 Feb;119(2):393-402. doi: 10.1002/cpt.70096. Epub 2025 Oct 21.
PubMed 41121745
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04613518
- Acronym / sponsor ID
- IM011-127
- Conditions
- Colitis, Ulcerative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Posted 12 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability, efficacy, and biomarker response of BMS-986165 administered orally in participants with moderate to severe ulcerative colitis. The study was originally designed to test deucravacitinib at two doses for 12 weeks compared to placebo. After the initial 12-Week period, all subjects receive active therapy (open-label extension). With protocol amendment 2, one of the dose treatment arms is being removed from the 12-week double blind period with no change to the open-label extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BMS-986165 | Experimental | Drug: BMS-986165 |
| Placebo | Placebo comparator | Other: Placebo Comparator |
| Open label Extension, BMS-986165 | Experimental | Drug: BMS-986165 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of ulcerative colitis (UC) at least 3 months' duration prior to screening
- Moderately to severely active UC as assessed by the modified Mayo score
- Documentation of an inadequate response, loss of response, or intolerance to a treatment course of 1 or more of the following standard of care medications: oral 5-aminosalicylic acids, corticosteroids, immunomodulators, anti-tumor necrosis factor (TNF) agents, integrin inhibitors[SA1]
- Documentation of prior treatment with corticosteroids for ≥ 4 weeks
- Males and females must agree to follow specific methods of contraception, if applicable
Key exclusion criteria (6 listed)
- Current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC), ischemic colitis, or pseudomembranous colitis
- Current evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation
- History or evidence of any extensive colonic resection, or subtotal or total colectomy
- Women who are pregnant or breastfeeding
- Prior exposure to BMS-986165 or a tyrosine kinase 2 (TYK2) inhibitor
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-986165Specified Dose on Specified Days | Drug | BMS-986165, Open label Extension, BMS-986165 |
| Placebo ComparatorSpecified Dose on Specified Days | Other | Placebo |
Primary outcome
Percentage of Participants in Clinical Response at Week 12
Time frame: At week 12
Clinical response is defined as achieving the following changes in the modified Mayo score (excludes the physicians' global assessment) * A decrease from baseline in the modified Mayo score of ≥ 2 points, and * A decrease from baseline in the modified Mayo score ≥ 30%, and * A decrease in rectal bleeding (RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1 Note: The modified Mayo score calculated to determine eligibility will also be used as the baseline disease activity score. The modified Mayo score is a 9-point scale (a score of 5 to 9 points denotes moderate to severe disease). The modified Mayo score is a sum of the following 3 components: * Stool frequency (SF) subscore (0 to 3) * Rectal bleeding (RB) subscore (0 to 3) * Endoscopic (ES) subscore (0 to 3)
Number of Participants Experiencing Adverse Events (AEs)
Time frame: From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.
Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)
An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
Time frame: From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.
Number of Participants Experiencing Adverse Events of Special Interest (AEIs)
Time frame: From first dose to 52 weeks after first dose
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. AEs of special interest include: skin events, influenza, herpes viral infections, opportunistic infections, tuberculosis, cardiovascular events, malignancy, and COVID-19.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41121745Shin E, Bhat AG, Ramanathan M. Large Language Models for Clinical Trial Protocol Assessments. Clin Pharmacol Ther. 2026 Feb;119(2):393-402. doi: 10.1002/cpt.70096. Epub 2025 Oct 21.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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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
26 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-986165 in people with Colitis, Ulcerative, run by Bristol-Myers Squibb at 26 sites in 8 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Poland, Canada, Germany, Australia and 3 more countries. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants in Clinical Response at Week 12 (time frame: At week 12). 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?
On the ClinicalTrials.gov record for NCT04613518, which also lists 1 linked publication.
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 12 Jul 2024.