Ulcerative ColitisPhase 2NCT03934216

Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis

A Phase 2 study testing BMS-986165 in people with Ulcerative Colitis, run by Bristol-Myers Squibb at 107 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC). Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Ulcerative Colitis
What is being tested?: BMS-986165
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 131 participants
Where: 107 sitesin 13 countries
Study dates: 1 Jul 2019to 4 Apr 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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must have active ulcerative colitis (UC) extending ≥ 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit
Must have documented diagnosis of UC of at least 3 months' duration prior to screening
Must have active moderate to severe UC, as defined by a modified Mayo score of 5 to 9 points, inclusive, which includes a stool frequency (SF) subscore of ≥ 2, and a rectal bleeding (RB) subscore ≥ 1, and a screening endoscopic (ES) subscore of ≥ 2

Who cannot join

Previous/current documented diagnosis of CD, indeterminate colitis, ischemic colitis, or pseudomembranous colitis (other than associated with Clostridium difficile [C. difficile])
Stool positive for C. difficile toxin at screening visit
Current or recent (within 12 weeks prior to the randomization visit) evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation
Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

107 sites in 13 countries.

Country

City, postcode or hospital

107 sites in 13 countries

United States31 sites

Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge
Baton Rouge, Louisiana, 70809
Connecticut Clinical Research Foundation
Bristol, Connecticut, 06010
Local Institution - 0074
Charleston, South Carolina, 29425
Local Institution - 0047
Chevy Chase, Maryland, 20815
Consultants for Clinical Research
Cincinnati, Ohio, 45218
University of Florida
Gainesville, Florida, 32610-0316
University of Florida
Gainesville, Florida, 32611
Local Institution - 0097
Garland, Texas, 75044
Gastro One
Germantown, Tennessee, 38138
Local Institution - 0121
Glenview, Illinois, 60026
Infusion Associates
Grand Rapids, Michigan, 49525
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Local Institution - 0008
Houston, Texas, 77090
Local Institution - 0049
Lake Success, New York, 11042
Local Institution - 0002
Las Vegas, Nevada, 89123
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Local Institution - 0048
New Port Richey, Florida, 34653
New York University Langone Medical Center
New York, New York, 10016
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Rapid City Medical Center
Rapid City, South Dakota, 57701
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229
Local Institution - 0106
San Antonio, Texas, 78229
Local Institution - 0096
Seattle, Washington, 98101
Swedish First Hill Campus
Seattle, Washington, 98104
Local Institution - 0018
Shreveport, Louisiana, 71103
Texas Digestive Disease Consultants - Southlake
Southlake, Texas, 76092
Local Institution - 0011
Suwanee, Georgia, 30024
Local Institution - 0044
Sweetwater, Florida, 33172
Local Institution - 0116
Tyler, Texas, 75701
Local Institution - 0122
Vancouver, Washington, 98664

Other trials in United States

Poland16 sites

Local Institution - 0091
Bydgoszcz, 85-231
Local Institution - 0013
Bydgoszcz, 85-794
Local Institution - 0100
Lodz, 90-153
Local Institution - 0045
Lodz, 90-302
Local Institution - 0098
Nowy Targ, 34-400
Local Institution - 0094
Piotrkow Trybunalski, 97-300
Local Institution - 0040
Sopot, 81-756
Local Institution - 0053
Szczecin, 71-434
Local Institution - 0014
Tychy, 43 100
Centrum Zdrowia Matki Dziecka i Mlodziezy
Warsaw, 00-635
Local Institution - 0088
Warsaw, 00-728
Local Institution - 0095
Warsaw, 02-798
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz
Warsaw, 03-580
Local Institution - 0030
Warsaw, 03-712
Local Institution - 0037
Wroclaw, 53-114
Centrum Medyczne Oporow
Wroclaw, 54-416

Other trials in Poland

Japan10 sites

Local Institution - 0066
Bunkyo-ku, Tokyo, 113-8519
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, 818-8502
National Hospital Organization Hirosaki National Hospital
Hirosaki, Aomori, 036-8545
Local Institution - 0078
Kurume, Fukuoka, 830-0011
Local Institution - 0080
Minato-ku, Tokyo, 105-8471
Hyogo College of Medicine Hospital
Nishinomiya, Hyōgo, 663-8501
Shiga University of Medical Science Hospital
Ōtsu, Shiga, 520-2192
Local Institution - 0069
Saga, 849-8501
Local Institution - 0081
Sagamihara-shi, Kanagawa, 2520375
National Hospital Organization Takasaki General Medical Center
Takasaki, Gunma, 3700829

Other trials in Japan

Italy9 sites

Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi
Bologna, 40126
Local Institution - 0005
Catanzaro, 88100
Clinica Medica Azienda Ospedaliera Universitaria
Messina, 98125
Azienda Ospedaliera di Padova
Padova, 35128
Local Institution - 0027
Pavia, 27100
Policlinico Universitario Campus Bio-Medico
Roma, 00128
Local Institution - 0046
Roma, 00133
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
Local Institution - 0033
Rozzano, Milano, 20089

Other trials in Italy

Germany6 sites

Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum
Berlin, 13353
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Medizinische Hochschule Hannover
Hanover, 30625
Local Institution - 0070
Kiel, 24105
Local Institution - 0062
Leipzig, 04103
Universitatsklinik Ulm
Ulm, 89081

Other trials in Germany

Russia6 sites

Nizhniy Novgorod Regional Clinical Hospital N.A. Semashko
Nizhny Novgorod, 603126
Local Institution - 0020
Novosibirsk, 630005
Novosibirsk State Regional Clinical Hospital
Novosibirsk, 630087
Local Institution - 0092
Novosibirsk, 630099
Local Institution - 0015
Saratov, 410053
Multidisciplinary Consultative and Diagnostic Center
Tyumen, 625026

Other trials in Russia

South Korea6 sites

Local Institution - 0064
Daegu, 42415
Local Institution
Daegu, 700-712
Local Institution
Daegu, 700-721
Local Institution
Incheon, 22332
Local Institution
Seoul, 137-701
Local Institution
Seoul, 156-755

Other trials in South Korea

Hungary5 sites

Magyar Honvedseg-Egeszsegugyi Kozpont
Budapest, 1062
Local Institution - 0042
Budapest, 1088
Local Institution - 0024
Budapest, 1097
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Bugat Pal Korhaz
Gyöngyös, 3200

Other trials in Hungary

United Kingdom5 sites

Barnsley Hospital NHS Foundation Trust
Barnsley, S75 2EP
Local Institution - 0031
Cambridge, CB2 2QQ
NHS Greater Glasgow and Clyde
Glasgow, G51 4TF
Imperial College Healthcare NHS Trust
London, W2 1NY
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF

Other trials in United Kingdom

Australia4 sites

Local Institution - 0071
Bedford Park, South Australia, 5042
Local Institution - 0108
Melbourne, Victoria, 3181
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102

Other trials in Australia

France4 sites

Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord
Saint-Etienne, 42055
Local Institution
Toulouse, 31059

Other trials in France

Belgium3 sites

Local Institution - 0039
Antwerp, 2018
Local Institution - 0065
Brussels, 1000
Clinique du MontLegia - CHC
Liège, 4000

Other trials in Belgium

Czechia2 sites

Hepato-Gastroenterology HK
Hradec Králové, 500 12
Nemocnice Slany
Slaný, 274 01

Other trials in Czechia

About this study

Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis

The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).

Conditions: Ulcerative Colitis
Being tested: BMS-986165, Placebo
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
Also called Deucravacitinib
Specified Dose on Specified Days
PlaceboOther
Specified Dose on Specified Days

Study groups in NCT03934216
Study group	Role	What they receive
BMS-986165	Experimental	Not described Receives: Drug: BMS-986165
Placebo	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Remission Response Rate at Week 12
Clinical remission response rate is the percentage of participants achieving clinical remission, defined as absolute total Mayo Score and absolute Mayo endoscopy, stool frequency, rectal bleeding.
Will be calculated using a modified Mayo score with the following:
Stool Frequency (SF) sub score ≤ 1, with ≥ 1 point decrease from baseline, and Rectal Bleeding (RB) sub score = 0, and Endoscopic (ES) sub score ≤ 1 (modified, excludes friability)
The modified Mayo score (0 to 9 points) is the sum of 3 components: the SF, RB, and ES sub scores
Modified Mayo Score: The modified Mayo score is a 9-point scale; a score of 5 to 9 points (inclusive), which is required for randomization, denotes moderate to severe disease (by protocol definition). considered in clinical remission if a Mayo Score of less than or equal to 2 with no individual sub score greater than 1
Measured: From first dose to 12 weeks.

Secondary outcomes (3)

Clinical Response Rate at 12 Weeks
Clinical response is defined as percentage of participants with a reduction in total Mayo Score and reduction in rectal bleeding subscore
Will be defined as the following:
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
Measured: From first dose to 12 weeks
Endoscopic Response at Week 12
Endoscopic response will be defined as percentage of participants with a reduction in the total Ulcerative Colitis Endoscopic Index of Severity score.
The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scale:
Vascular Pattern:
- Normal (score 0)
- patchy obliteration (score 1)
- Obliterated (score 2)
Bleeding
- None (score 0)
- Mucosal (score 1)
- Luminal mild (score 2)
- Luminal Moderate or severe (score 3)
Erosions and Ulcers
- None (score 0)
- Erosions ( score 1)
- Superficial Ulcer (2)
- Deep Ulcer (score 3)
A total score represents the following: remission (0-1); mild (2-4); moderate (5-6); and severe (7-8).
Measured: up to 12 Weeks
Histological Improvement Response Rate at 12 Weeks
Histologic improvement is defined as percentage of participants with a Geboes score of ≤ 3.1
Neutrophils <5% of crypts, with no crypt destruction, erosions, ulcerations, and granulation tissue.
Achieving the following scores for the corresponding grades of the Geboes score:
- Score of 0 or 1 for Grade 3 (neutrophils in the epithelium: none or < 5% crypts involved), and
- Score of 0 for Grade 4 (crypt destruction: none), and
- Score of 0 Grade 5 (erosion or ulceration: no erosions, ulcerations, or granulation tissue) grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher score indicates more severe disease
Measured: up to 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20194 Apr 2023

First posted1 May 2019
Study start1 Jul 2019
Primary completion13 Jun 2021
Study completion4 Apr 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.
Other trials for Ulcerative ColitisStudies 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: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03934216
Sponsor's protocol ID: IM011-024
Other IDs: 2018-004694-27, 2018
Status last verified: Feb 2024
First submitted: 30 Apr 2019
Last updated: 6 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 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 and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis
ClinicalTrials.gov ID: NCT03934216
Acronym / sponsor ID: IM011-024
Conditions: Ulcerative Colitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 131 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 1 Jul 2019 (actual)
Primary completion: 13 Jun 2021 (actual)
Study completion: 4 Apr 2023 (actual)
First posted: 1 May 2019 (actual)
Results: Posted 6 Jul 2022

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 efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
BMS-986165	Experimental	Drug: BMS-986165
Placebo	Placebo comparator	Other: Placebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Must have active ulcerative colitis (UC) extending ≥ 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit
Must have documented diagnosis of UC of at least 3 months' duration prior to screening
Must have active moderate to severe UC, as defined by a modified Mayo score of 5 to 9 points, inclusive, which includes a stool frequency (SF) subscore of ≥ 2, and a rectal bleeding (RB) subscore ≥ 1, and a screening endoscopic (ES) subscore of ≥ 2

Key exclusion criteria (4 listed)

Previous/current documented diagnosis of CD, indeterminate colitis, ischemic colitis, or pseudomembranous colitis (other than associated with Clostridium difficile [C. difficile])
Stool positive for C. difficile toxin at screening visit
Current or recent (within 12 weeks prior to the randomization visit) evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation
Other protocol-defined inclusion/exclusion criteria 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-986165Also: DeucravacitinibSpecified Dose on Specified Days	Drug	BMS-986165
PlaceboSpecified Dose on Specified Days	Other	Placebo

Primary outcome

Clinical Remission Response Rate at Week 12
Time frame: From first dose to 12 weeks.
Clinical remission response rate is the percentage of participants achieving clinical remission, defined as absolute total Mayo Score and absolute Mayo endoscopy, stool frequency, rectal bleeding. Will be calculated using a modified Mayo score with the following: Stool Frequency (SF) sub score ≤ 1, with ≥ 1 point decrease from baseline, and Rectal Bleeding (RB) sub score = 0, and Endoscopic (ES) sub score ≤ 1 (modified, excludes friability) The modified Mayo score (0 to 9 points) is the sum of 3 components: the SF, RB, and ES sub scores Modified Mayo Score: The modified Mayo score is a 9-point scale; a score of 5 to 9 points (inclusive), which is required for randomization, denotes moderate to severe disease (by protocol definition). considered in clinical remission if a Mayo Score of less than or equal to 2 with no individual sub score greater than 1

3 secondary outcomes

Clinical Response Rate at 12 Weeks
Time frame: From first dose to 12 weeks
Endoscopic Response at Week 12
Time frame: up to 12 Weeks
Histological Improvement Response Rate at 12 Weeks
Time frame: up to 12 Weeks

Results and safety

Results posted to the registry on 6 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	88	30
Placebo	43	12

Primary outcome: Clinical Remission Response Rate at Week 12

Time frame: From first dose to 12 weeks.. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Treatment n = 88	Placebo n = 43
Value	14.8 (7.4 to 22.2)	16.3 (5.2 to 27.3)

Treatment vs Placebo: Odds Ratio (OR): 0.9 (95% CI 0.3 to 2.4), p = 0.5935, Stratified Cochran-Mantel-Haenszel

Population analysed: All Randomized Participants

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	19 of 87 (21.8%)	64 of 87 (73.6%)	2 of 87
Placebo	2 of 10 (20%)	6 of 10 (60%)	0 of 10
BMS-986165 6mg BID During OL Period After Receiving Placebo in Induction Period	4 of 32 (12.5%)	22 of 32 (68.8%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Ulcerative Colitis

Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
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RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
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RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
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Enrolling by invitationPhase 4
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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

107 sites in 13 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 Ulcerative Colitis, run by Bristol-Myers Squibb at 107 sites in 13 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 3 inclusion and 4 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 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States, Poland, Japan, Italy, Germany and 8 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 6 Jul 2022). 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?

Clinical Remission Response Rate at Week 12 (time frame: From first dose to 12 weeks.). 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 NCT03934216.

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 6 Mar 2024.