Crohn DiseasePhase 2NCT04877990

A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis

A Phase 2 study testing Deucravacitinib in people with Crohn Disease and Ulcerative Colitis, run by Bristol-Myers Squibb at 43 sites in 16 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 evaluate the long-term safety and efficacy of Deucravacitinib in participants who have previously been enrolled in a Deucravacitinib Phase 2 study for moderate to severe Crohn's disease or moderate to severe Ulcerative Colitis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Crohn Disease, Ulcerative Colitis
What is being tested?: Deucravacitinib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 43 sitesin 16 countries
Study dates: 7 May 2021to 29 Aug 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Previously completed open-label extension treatment in one of the parent Crohn's disease or ulcerative colitis studies

Who cannot join

Women who are pregnant or breastfeeding
Current colonic adenomas or dysplasia diagnosed at the endoscopy performed at the end of treatment visit of the parent study or past confirmed colonic dysplasia in the parent study that has not been eradicated
Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

43 sites in 16 countries.

Country

City, postcode or hospital

43 sites in 16 countries

Poland11 sites

Local Institution - 0022
Bydgoszcz, 85-231
Local Institution - 0003
Bydgoszcz, 85-794
Local Institution - 0001
Krakow, 31-501
Local Institution - 0046
Nowy Targ, Lesser Poland Voivodeship, 34-400
Local Institution - 0028
Sopot, 81-756
Local Institution - 0025
Szczecin, 71-434
Local Institution - 0061
Tychy, Silesian Voivodeship, 43-100
Local Institution - 0035
Warsaw, 00-728
Local Institution - 0048
Warsaw, 02-798
Local Institution - 0004
Warsaw, 03-712
Local Institution - 0018
Wroclaw, 53-114

Other trials in Poland

United States10 sites

Local Institution - 0066
Charleston, South Carolina, 29425
Local Institution - 0041
Cleveland, Ohio, 44195
Local Institution - 0053
Garland, Texas, 75044
Local Institution - 0037
Jackson, Mississippi, 39216
Local Institution - 0038
Pittsburgh, Pennsylvania, 15213
Local Institution - 0055
Richmond, Virginia, 23249
Local Institution - 0056
San Antonio, Texas, 78229
Local Institution - 0036
Shreveport, Louisiana, 71105
Local Institution - 0049
Tyler, Texas, 75701
Local Institution - 0002
Wyoming, Michigan, 49519

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Japan5 sites

Local Institution - 0026
Bunkyo-ku, Tokyo, 1138519
Local Institution - 0063
Hirosaki, Aomori, 036-8545
Local Institution - 0044
Minato-ku, Tokyo, 105-8471
Local Institution - 0027
Saga, Saga-ken, 8498501
Local Institution - 0047
Sagamihara, Kanagawa, 252-0375

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China2 sites

Local Institution - 0030
Guangzhou, Guangdong, 510080
Local Institution - 0029
Guangzhou, Guangdong, 510655

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Hungary2 sites

Local Institution - 0062
Budapest, 1083
Local Institution - 0023
Budapest, 1088

Other trials in Hungary

Italy2 sites

Fondazione Irccs - Policlinico San Matteo
Pavia, 27100
Humanitas
Rozzano, Lombardy, 20089

Other trials in Italy

Russia2 sites

Local Institution
Irkutsk, 664033
Local Institution
Saint Petersburg, 195257

Other trials in Russia

Australia1 site

Local Institution - 0013
Ballarat, Victoria, 3350

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Canada1 site

Local Institution - 0050
Vaughan, Ontario, L4L 4Y7

Other trials in Canada

Germany1 site

Local Institution - 0012
Kiel, 24105

Other trials in Germany

Netherlands1 site

Local Institution - 0060
Amsterdam, North Holland, 1105 AZ

Other trials in Netherlands

Portugal1 site

Local Institution - 0054
Santa Maria da Feira, 4520-211

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Romania1 site

Local Institution
Bucharest, 020125

Other trials in Romania

Spain1 site

Local Institution - 0045
Fuenlabrada, Madrid, 28942

Other trials in Spain

Taiwan1 site

Local Institution - 0064
Taipei, 10002

Other trials in Taiwan

United Kingdom1 site

Local Institution - 0034
Morriston, SA6 6NL

Other trials in United Kingdom

About this study

Official title: An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis

Conditions: Crohn Disease, Ulcerative Colitis
Being tested: Deucravacitinib
Keywords: BMS-986165, Crohn Colitis, Crohn Disease, Crohn Iliocolitis, Inflammatory Bowel Disease, Ulcerative Colitis, Deucravacitinib
Medical subject headings: Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DeucravacitinibDrug
Specified dose on specified days

Study groups in NCT04877990
Study group	Role	What they receive
Long-Term Extension Rollover Study: Deucravacitinib	Experimental	Not described Receives: Drug: Deucravacitinib

What is being measured

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

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Number of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEs of interest (AEIs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect. TEAEs are defined as AEs with an onset date on or after the first dose of study treatment up to 30 days after the last dose of study treatment in the study, or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment
Measured: From first dose to 30 days post last dose (Up to 110 weeks)
Number of Participants With Laboratory Abnormalities
Number of participants experiencing abnormalities in laboratory testing including chemistry, hematology, and renal.
Measured: From first dose to 30 days post last dose (Up to 110 weeks)
Number of Participants With Electrocardiogram (ECG) Abnormalities
Measured: From first dose to 30 days post last dose (Up to 110 weeks)
Number of Participants With Vital Signs Abnormalities
Measured: From first dose to 30 days post last dose (Up to 110 weeks)
Change From Baseline in Laboratory Parameters
Change from baseline in laboratory parameters including lipid profile, chemistry liver function, chemistry (other), and chemistry renal function
Measured: Baseline, Week 12, Week 108
Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate
Changes from IM011077 study baseline in electrocardiogram (ECG) parameters - ECG mean heart rate
Measured: Baseline, Week 48, Week 96
Change From Baseline in Electrocardiogram (ECG) Parameters
Changes from IM011077 study baseline in electrocardiogram (ECG) parameters
Measured: Baseline, Week 48, Week 96
Change From Baseline in Vital Signs Parameters - Heart Rate
Changes from IM011077 study baseline in vital signs parameters - heart rate
Measured: Baseline, Week 12, Week 108
Change From Baseline in Vital Signs Parameters
Changes from IM011077 study baseline in vital signs parameters
Measured: Baseline, Week 12, Week 108

Timeline

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

7 May 202129 Aug 2023

First posted7 May 2021
Study start7 May 2021
Primary completion29 Aug 2023
Study completion29 Aug 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 Crohn DiseaseStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04877990
Sponsor's protocol ID: IM011-077
Other IDs: 2020-004461-40, U1111-1258-3838
Status last verified: Aug 2024
First submitted: 4 May 2021
Last updated: 24 Sep 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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A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis
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Active, not recruitingPhase 2
Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy
Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
Not yet recruitingPhase 1
Study of Single and Multiple Ascending Doses of CM551 in Healthy Participants
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RecruitingPhase 4
A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting
Ulcerative Colitis, Crohn's Disease

All Crohn Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis
ClinicalTrials.gov ID: NCT04877990
Acronym / sponsor ID: IM011-077
Conditions: Crohn Disease, Ulcerative Colitis
Keywords: BMS-986165, Crohn Colitis, Crohn Disease, Crohn Iliocolitis, Inflammatory Bowel Disease, Ulcerative Colitis, Deucravacitinib
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 7 May 2021 (actual)
Primary completion: 29 Aug 2023 (actual)
Study completion: 29 Aug 2023 (actual)
First posted: 7 May 2021 (actual)
Results: Posted 24 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Long-Term Extension Rollover Study: Deucravacitinib	Experimental	Drug: Deucravacitinib

Who may qualify

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

Key inclusion criteria (1 listed)

Previously completed open-label extension treatment in one of the parent Crohn's disease or ulcerative colitis studies

Key exclusion criteria (3 listed)

Women who are pregnant or breastfeeding
Current colonic adenomas or dysplasia diagnosed at the endoscopy performed at the end of treatment visit of the parent study or past confirmed colonic dysplasia in the parent study that has not been eradicated
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
DeucravacitinibSpecified dose on specified days	Drug	Long-Term Extension Rollover Study: Deucravacitinib

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: From first dose to 30 days post last dose (Up to 110 weeks)
Number of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEs of interest (AEIs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect. TEAEs are defined as AEs with an onset date on or after the first dose of study treatment up to 30 days after the last dose of study treatment in the study, or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment
Number of Participants With Laboratory Abnormalities
Time frame: From first dose to 30 days post last dose (Up to 110 weeks)
Number of participants experiencing abnormalities in laboratory testing including chemistry, hematology, and renal.
Number of Participants With Electrocardiogram (ECG) Abnormalities
Time frame: From first dose to 30 days post last dose (Up to 110 weeks)
Number of Participants With Vital Signs Abnormalities
Time frame: From first dose to 30 days post last dose (Up to 110 weeks)
Change From Baseline in Laboratory Parameters
Time frame: Baseline, Week 12, Week 108
Change from baseline in laboratory parameters including lipid profile, chemistry liver function, chemistry (other), and chemistry renal function
Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate
Time frame: Baseline, Week 48, Week 96
Changes from IM011077 study baseline in electrocardiogram (ECG) parameters - ECG mean heart rate
Change From Baseline in Electrocardiogram (ECG) Parameters
Time frame: Baseline, Week 48, Week 96
Changes from IM011077 study baseline in electrocardiogram (ECG) parameters
Change From Baseline in Vital Signs Parameters - Heart Rate
Time frame: Baseline, Week 12, Week 108
Changes from IM011077 study baseline in vital signs parameters - heart rate
Change From Baseline in Vital Signs Parameters
Time frame: Baseline, Week 12, Week 108
Changes from IM011077 study baseline in vital signs parameters

Results and safety

Results posted to the registry on 24 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Crohn's Disease	26	24
Ulcerative Colitis	41	41

Primary outcome: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Time frame: From first dose to 30 days post last dose (Up to 110 weeks). Count of participants. Unit: Participants

Measure	Crohn's Disease n = 24	Ulcerative Colitis n = 41
TEAEs	18	19
TESAEs	2	2
TEAEs leading to study discontinuation	1	1
AEs of Interest - Skin-related events	0	2
AEs of Interest - Creatine Kinase events	2	3

Population analysed: All treated participants

Primary outcome: Number of Participants With Laboratory Abnormalities

Time frame: From first dose to 30 days post last dose (Up to 110 weeks). Count of participants. Unit: Participants

Measure	Crohn's Disease n = 23	Ulcerative Colitis n = 41
Sodium < 130 or > 150 MEQ/L (MMOL/L)	0	0
Potassium < 3 or > 5.5 MEQ/L (MMOL/L)	0	1
Calcium > 12.5 MG/DL	0	0
Fasting Serum Glucose < 50 MG/DL or > 250 MG/DL	0	0
Albumin < 2.0 G/DL	0	0
Creatine Kinase > 10xupper limit of normal	0	0
Hemoglobin < 7.0 G/DL or > 30% reduction from baseline	0	0
Hematocrit < 20% or 30% reduction from baseline	0	0

Population analysed: All treated participants with laboratory measurements

Primary outcome: Number of Participants With Electrocardiogram (ECG) Abnormalities

Time frame: From first dose to 30 days post last dose (Up to 110 weeks). Count of participants. Unit: Participants

Measure	Crohn's Disease n = 24	Ulcerative Colitis n = 41
QTCF (MSEC) 450 - < 480	1	0
QTCF (MSEC) 480 - < 500	0	1
QTCF (MSEC) >= 500	0	0
30 < CHANGE FROM IM011077 STUDY BASELINE <= 60 MSEC	3	0
CHANGE FROM IM011077 STUDY BASELINE > 60 MSEC	3	5
PRAG (MSEC) P WAVE AND R WAVE (PR) INTERVAL >= 240 MSEC	0	0
QRSAG(MSEC) QRS INTERVAL >= 200 MSEC	0	0

Population analysed: All treated participants with ECG measurements

Primary outcome: Number of Participants With Vital Signs Abnormalities

Time frame: From first dose to 30 days post last dose (Up to 110 weeks). Count of participants. Unit: Participants

Measure	Crohn's Disease n = 24	Ulcerative Colitis n = 41
HEART RATE (BEATS/MIN): VALUE > 100 AND CHANGE FROM IM011077 STUDY BASELINE > 30	1	1
HEART RATE (BEATS/MIN): VALUE < 55 AND CHANGE FROM IM011077 STUDY BASELINE < -15	1	0
SYSTOLIC BLOOD PRESSURE (MMHG): VALUE > 140 AND CHANGE FROM IM011077 STUDY BASELINE > 20	3	5
SYSTOLIC BLOOD PRESSURE (MMHG): VALUE < 90 AND CHANGE FROM IM011077 STUDY BASELINE < -20	0	0
DIASTOLIC BLOOD PRESSURE (MMHG): VALUE > 90 AND CHANGE FROM IM011077 STUDY BASELINE > 10	3	5
DIASTOLIC BLOOD PRESSURE (MMHG): VALUE < 55 AND CHANGE FROM IM011077 STUDY BASELINE < -10	0	0

Population analysed: All treated participants with vital signs measurements

Adverse events

Time frame: SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CROHN'S DISEASE	2 of 24 (8.3%)	12 of 24 (50%)	0 of 26
ULCERATIVE COLITIS	2 of 41 (4.9%)	13 of 41 (31.7%)	0 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 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.

Related trials for Crohn Disease

Recruiting
A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis
Inflammatory Bowel Disease
Active, not recruitingPhase 2
Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy
Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
Not yet recruitingPhase 1
Study of Single and Multiple Ascending Doses of CM551 in Healthy Participants
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RecruitingPhase 4
A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting
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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

43 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Deucravacitinib in people with Crohn Disease and Ulcerative Colitis, run by Bristol-Myers Squibb at 43 sites in 16 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 1 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: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Poland, United States, Japan, China, Hungary and 11 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. 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 24 Sep 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?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) (time frame: From first dose to 30 days post last dose (Up to 110 weeks)). The study lists 9 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 NCT04877990.

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 24 Sep 2024.