NCT04877990 is a Phase 2 clinical trial of Deucravacitinib in Crohn Disease, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT04877990?

NCT04877990 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT04877990?

Interventions in NCT04877990: Deucravacitinib.

What condition does NCT04877990 study?

NCT04877990 studies Crohn Disease, Ulcerative Colitis.

Is NCT04877990 still recruiting?

NCT04877990 is currently completed. Last updated 24 September 2024.

Are results published for NCT04877990?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-09-24 · How we verify

NCT04877990

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 24 September 2024

What this trial tests

Phase 2 trial testing Deucravacitinib in Crohn Disease in 67 participants. Completed in 29 August 2023.

Timeline

7 May 2021

Primary endpoint
29 August 2023

29 August 2023

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	67
Start date	7 May 2021
Primary completion	29 August 2023
Estimated completion	29 August 2023
Sites	43 locations across Italy, Japan, Netherlands, Russia, Taiwan, United Kingdom, Germany, Hungary

Drugs / interventions tested

Deucravacitinib (DEUCRAVACITINIB) — full drug profile →

Conditions studied

Crohn Disease — all drugs for Crohn Disease →
Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with Crohn Disease or Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) Primary · 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 def

TEAEs

Group	Value	95% CI
Crohn's Disease	18
Ulcerative Colitis	19

TESAEs

Group	Value	95% CI
Crohn's Disease	2
Ulcerative Colitis	2

TEAEs leading to study discontinuation

Group	Value	95% CI
Crohn's Disease	1
Ulcerative Colitis	1

AEs of Interest - Skin-related events

Group	Value	95% CI
Crohn's Disease	0
Ulcerative Colitis	2

AEs of Interest - Creatine Kinase events

Group	Value	95% CI
Crohn's Disease	2
Ulcerative Colitis	3

Number of Participants With Laboratory Abnormalities Primary · 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.

Sodium < 130 or > 150 MEQ/L (MMOL/L)

Group	Value	95% CI
Crohn's Disease	0
Ulcerative Colitis	0

Potassium < 3 or > 5.5 MEQ/L (MMOL/L)

Group	Value	95% CI
Crohn's Disease	0
Ulcerative Colitis	1

Calcium > 12.5 MG/DL

Group	Value	95% CI
Crohn's Disease	0
Ulcerative Colitis	0

Fasting Serum Glucose < 50 MG/DL or > 250 MG/DL

Group	Value	95% CI
Crohn's Disease	0
Ulcerative Colitis	0

Albumin < 2.0 G/DL

Group	Value	95% CI
Crohn's Disease	0
Ulcerative Colitis	0

Creatine Kinase > 10xupper limit of normal

Group	Value	95% CI
Crohn's Disease	0
Ulcerative Colitis	0

Hemoglobin < 7.0 G/DL or > 30% reduction from baseline

Group	Value	95% CI
Crohn's Disease	0
Ulcerative Colitis	0

Hematocrit < 20% or 30% reduction from baseline

Group	Value	95% CI
Crohn's Disease	0
Ulcerative Colitis	0

Number of Participants With Electrocardiogram (ECG) Abnormalities Primary · From first dose to 30 days post last dose (Up to 110 weeks)

QTCF (MSEC) 450 - < 480

Group	Value	95% CI
Crohn's Disease	1
Ulcerative Colitis	0

QTCF (MSEC) 480 - < 500

Group	Value	95% CI
Crohn's Disease	0
Ulcerative Colitis	1

QTCF (MSEC) >= 500

Group	Value	95% CI
Crohn's Disease	0
Ulcerative Colitis	0

30 < CHANGE FROM IM011077 STUDY BASELINE <= 60 MSEC

Group	Value	95% CI
Crohn's Disease	3
Ulcerative Colitis	0

CHANGE FROM IM011077 STUDY BASELINE > 60 MSEC

Group	Value	95% CI
Crohn's Disease	3
Ulcerative Colitis	5

PRAG (MSEC) P WAVE AND R WAVE (PR) INTERVAL >= 240 MSEC

Group	Value	95% CI
Crohn's Disease	0
Ulcerative Colitis	0

QRSAG(MSEC) QRS INTERVAL >= 200 MSEC

Group	Value	95% CI
Crohn's Disease	0
Ulcerative Colitis	0

Number of Participants With Vital Signs Abnormalities Primary · From first dose to 30 days post last dose (Up to 110 weeks)

HEART RATE (BEATS/MIN): VALUE > 100 AND CHANGE FROM IM011077 STUDY BASELINE > 30

Group	Value	95% CI
Crohn's Disease	1
Ulcerative Colitis	1

HEART RATE (BEATS/MIN): VALUE < 55 AND CHANGE FROM IM011077 STUDY BASELINE < -15

Group	Value	95% CI
Crohn's Disease	1
Ulcerative Colitis	0

SYSTOLIC BLOOD PRESSURE (MMHG): VALUE > 140 AND CHANGE FROM IM011077 STUDY BASELINE > 20

Group	Value	95% CI
Crohn's Disease	3
Ulcerative Colitis	5

SYSTOLIC BLOOD PRESSURE (MMHG): VALUE < 90 AND CHANGE FROM IM011077 STUDY BASELINE < -20

Group	Value	95% CI
Crohn's Disease	0
Ulcerative Colitis	0

DIASTOLIC BLOOD PRESSURE (MMHG): VALUE > 90 AND CHANGE FROM IM011077 STUDY BASELINE > 10

Group	Value	95% CI
Crohn's Disease	3
Ulcerative Colitis	5

DIASTOLIC BLOOD PRESSURE (MMHG): VALUE < 55 AND CHANGE FROM IM011077 STUDY BASELINE < -10

Group	Value	95% CI
Crohn's Disease	0
Ulcerative Colitis	0

Change From Baseline in Laboratory Parameters Primary · Baseline, Week 12, Week 108

Change from baseline in laboratory parameters including lipid profile, chemistry liver function, chemistry (other), and chemistry renal function

Cholesterol, Fasting Week 12

Group	Value	95% CI
Crohn's Disease	10.20	± 7.207
Ulcerative Colitis	-9.17	± 4.629

Cholesterol, Fasting Week 108

Group	Value	95% CI
Crohn's Disease	-12.00	± NA

HDL Cholesterol, Fasting Week 12

Group	Value	95% CI
Crohn's Disease	-0.75	± 3.400
Ulcerative Colitis	-0.83	± 2.626

HDL Cholesterol, Fasting Week 108

Group	Value	95% CI
Crohn's Disease	0.00	± NA

LDL Cholesterol, Fasting Week 12

Group	Value	95% CI
Crohn's Disease	4.75	± 4.270
Ulcerative Colitis	-6.50	± 4.689

LDL Cholesterol, Fasting Week 108

Group	Value	95% CI
Crohn's Disease	1.00	± NA

Triglycerides, Fasting Week 12

Group	Value	95% CI
Crohn's Disease	2.3	± 11.31
Ulcerative Colitis	3.2	± 4.78

Triglycerides, Fasting Week 108

Group	Value	95% CI
Crohn's Disease	-62.0	± NA

Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate Primary · Baseline, Week 48, Week 96

Changes from IM011077 study baseline in electrocardiogram (ECG) parameters - ECG mean heart rate

ECG Mean Heart Rate, Week 48

Group	Value	95% CI
Crohn's Disease	-1.4	± 9.21
Ulcerative Colitis	2.6	± 12.76

ECG Mean Heart Rate, Week 96

Group	Value	95% CI
Crohn's Disease	-1.0	± 11.27
Ulcerative Colitis	-1.0	± NA

Change From Baseline in Electrocardiogram (ECG) Parameters Primary · Baseline, Week 48, Week 96

Changes from IM011077 study baseline in electrocardiogram (ECG) parameters

PR Interval, Aggregate, Week 48

Group	Value	95% CI
Crohn's Disease	9.1	± 20.62
Ulcerative Colitis	-2.4	± 22.65

PR Interval, Aggregate, Week 96

Group	Value	95% CI
Crohn's Disease	14.7	± 16.56
Ulcerative Colitis	-22.0	± NA

QRS Duration, Aggregate, Week 48

Group	Value	95% CI
Crohn's Disease	-1.2	± 8.47
Ulcerative Colitis	-0.9	± 8.53

QRS Duration, Aggregate, Week 96

Group	Value	95% CI
Crohn's Disease	-9.3	± 2.89
Ulcerative Colitis	0.0	± NA

QT Interval, Aggregate, Week 48

Group	Value	95% CI
Crohn's Disease	18.6	± 30.33
Ulcerative Colitis	7.6	± 40.35

QT Interval, Aggregate, Week 96

Group	Value	95% CI
Crohn's Disease	27.0	± 62.55
Ulcerative Colitis	96.0	± NA

QTcB Interval, Aggregate, Week 48

Group	Value	95% CI
Crohn's Disease	-2.3	± 21.78
Ulcerative Colitis	7.7	± 19.41

Change From Baseline in Vital Signs Parameters - Heart Rate Primary · Baseline, Week 12, Week 108

Changes from IM011077 study baseline in vital signs parameters - heart rate

Heart Rate Week 12

Group	Value	95% CI
Crohn's Disease	3.6	± 11.89
Ulcerative Colitis	0.9	± 10.71

Heart Rate Week 108

Group	Value	95% CI
Crohn's Disease	1.0	± NA

Change From Baseline in Vital Signs Parameters Primary · Baseline, Week 12, Week 108

Changes from IM011077 study baseline in vital signs parameters

Systolic Blood Pressure Week 12

Group	Value	95% CI
Crohn's Disease	3.8	± 11.56
Ulcerative Colitis	3.8	± 13.62

Systolic Blood Pressure Week 108

Group	Value	95% CI
Crohn's Disease	4.0	± NA

Diastolic Blood Pressure Week 12

Group	Value	95% CI
Crohn's Disease	0.3	± 7.82
Ulcerative Colitis	-1.3	± 7.38

Diastolic Blood Pressure Week 108

Group	Value	95% CI
Crohn's Disease	9.0	± NA

Adverse events — posted to ClinicalTrials.gov

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).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CROHN'S DISEASE

Serious: 2/24 (8%)

Deaths: 0/26

ULCERATIVE COLITIS

Serious: 2/41 (5%)

Deaths: 0/41

Serious adverse events (8 terms)

Reaction	System	CROHN'S DISEASE	ULCERATIVE COLITIS
Cardiac failure chronic	Cardiac disorders	—	—
Colitis ulcerative	Gastrointestinal disorders	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—
General physical health deterioration	General disorders	—	—
Pneumonia	Infections and infestations	—	—
Sepsis	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Procedural pneumothorax	Injury, poisoning and procedural complications	—	—

Other adverse events (10 terms — click to expand)

Reaction	System	CROHN'S DISEASE	ULCERATIVE COLITIS
COVID-19	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Colitis ulcerative	Gastrointestinal disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Tonsillitis	Infections and infestations	—	—
Depression	Psychiatric disorders	—	—
Mouth ulceration	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Cardiac failure chronic, Colitis ulcerative, Small intestinal obstruction, General physical health deterioration, Pneumonia, Sepsis, Urinary tract infection, Procedural pneumothorax.

Data from ClinicalTrials.gov NCT04877990 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Deuterium in drug discovery: progress, opportunities and challenges.
Di Martino RMC, Maxwell BD, Pirali T. · · 2023 · cited 228× · PMID 37277503 · DOI 10.1038/s41573-023-00703-8
JAK/STAT pathway: Extracellular signals, diseases, immunity, and therapeutic regimens.
Hu Q, Bian Q, Rong D, Wang L, et al · · 2023 · cited 190× · PMID 36911202 · DOI 10.3389/fbioe.2023.1110765
Deucravacitinib: First Approval.
Hoy SM. · · 2022 · cited 113× · PMID 36401743 · DOI 10.1007/s40265-022-01796-y
Safety of Janus Kinase Inhibitors in Inflammatory Bowel Diseases.
Núñez P, Quera R, Yarur AJ. · · 2023 · cited 64× · PMID 36913180 · DOI 10.1007/s40265-023-01840-5
Tyk2 Targeting in Immune-Mediated Inflammatory Diseases.
Rusiñol L, Puig L. · · 2023 · cited 54× · PMID 36834806 · DOI 10.3390/ijms24043391
Allosteric TYK2 inhibition: redefining autoimmune disease therapy beyond JAK1-3 inhibitors.
Jensen LT, Attfield KE, Feldmann M, Fugger L. · · 2023 · cited 45× · PMID 37863021 · DOI 10.1016/j.ebiom.2023.104840
Unmet Challenges in Patients with Crohn's Disease.
Scheurlen KM, Parks MA, Macleod A, Galandiuk S. · · 2023 · cited 14× · PMID 37685662 · DOI 10.3390/jcm12175595
Anti-IL23/12 agents and JAK inhibitors for inflammatory bowel disease.
Tian Z, Zhao Q, Teng X. · · 2024 · cited 13× · PMID 39086483 · DOI 10.3389/fimmu.2024.1393463

Verify or expand the search:

Other trials of Deucravacitinib

Trials testing the same drug.

NCT07280702 — Deucravacitinib-TNFi Combination Therapy for Difficult-to-Control Psoriatic Disease · Phase 4 · not yet recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting
NCT06979453 — A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants Wit · Phase 3 · recruiting
NCT07116967 — Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK) · Phase 3 · recruiting
NCT07256015 — Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy · recruiting

Other recruiting trials for Crohn Disease

Currently open trials in the same condition.

NCT06953791 — Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Pat · Phase 2 · recruiting
NCT07310095 — A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) · Phase 4 · recruiting
NCT07364734 — Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease · recruiting
NCT07170462 — Cranberry and Gut Health in Crohn's Disease · EARLY_PHASE1 · recruiting
NCT07196722 — A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease · Phase 2, PHASE3 · recruiting

Other Bristol-Myers Squibb trials

Trials by the same sponsor.

NCT07441408 — Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre · Phase 4 · not yet recruiting
NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder · Phase 3 · not yet recruiting
NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04877990 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 24 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04877990.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing