Evidence map›Paper›PMID 40355364›Full record

Trial reportJournal of Crohn's & colitis2025

Deucravacitinib in patients with inflammatory bowel disease: 12-week efficacy and safety results from 3 randomized phase 2 studies in Crohn's disease and ulcerative colitis.

Geert D'Haens, Silvio Danese, Remo Panaccione, David T Rubin, Laurent Peyrin-Biroulet, Katsuyoshi Matsuoka, Edward V Loftus, Taku Kobayashi, Walid Elsharkawi, Rosa Miceli and 7 more

Erratum issued 3 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of Crohn's & colitis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03599622 phase2terminatednot on this map

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Crohn's Disease

TypeinterventionalSponsorBristol-Myers SquibbRan2018 to 2023Enrolled239ConditionsGranulomatous Colitis, Crohn's Disease, Crohn's Enteritis, Granulomatous EnteritisArmsBMS-986165, Placebo
NCT03934216 phase2completednot on this map

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

TypeinterventionalSponsorBristol-Myers SquibbRan2019 to 2023Enrolled131ConditionsUlcerative ColitisArmsBMS-986165, Placebo
NCT04613518 phase2completednot on this map

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

TypeinterventionalSponsorBristol-Myers SquibbRan2021 to 2023Enrolled38ConditionsColitis, UlcerativeArmsBMS-986165, Placebo Comparator
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review of Promising Off-Label Use of Deucravacitinib.International journal of molecular sciences · 2025
    Review
  7. Review
  8. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors.

Geert D'HaensDepartment of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.ORCID 0000-0003-2784-4046
Silvio DaneseDepartment of Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University, Milan, Italy.ORCID 0000-0001-7341-1351
Remo PanaccioneDepartment of Medicine, Inflammatory Bowel Disease Clinic, Calgary, Alberta, Canada.ORCID 0000-0002-5247-940X
David T RubinInflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL, United States.
Laurent Peyrin-BirouletDepartment of Gastroenterology, INFINY Institute, INSERM NGERE, CHRU Nancy, Vandœuvre-lès-Nancy, France.
Katsuyoshi MatsuokaDivision of Gastroenterology and Hepatology, Toho University Sakura Medical Center, Sakura, Chiba, Japan.
Edward V LoftusDivision of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, MN, United States.
Taku KobayashiKitasato University Kitasato Institute Hospital, Tokyo, Japan.ORCID 0000-0002-2073-4234
Walid ElsharkawiBristol Myers Squibb, Princeton, NJ, United States.
Rosa MiceliBristol Myers Squibb, Princeton, NJ, United States.
Samia AhmedBristol Myers Squibb, Princeton, NJ, United States.
Yi LuoBristol Myers Squibb, Princeton, NJ, United States.
Andrew NapoliBristol Myers Squibb, Princeton, NJ, United States.
John VaileBristol Myers Squibb, Princeton, NJ, United States.
Quentin DornicBristol Myers Squibb, Princeton, NJ, United States.
Aditya PatelBristol Myers Squibb, Princeton, NJ, United States.
Stefan SchreiberDepartment of Internal Medicine I, University Hospital Schleswig-Holstein, Kiel University, Kiel, Germany.ORCID 0000-0003-2254-7771

Funding

Bristol Myers Squibb
6 · The paper itself

Abstract

BACKGROUND AND

aimsTyrosine kinase 2 is a downstream intracellular mediator of interleukin-23 signaling, which has a key role in the pathogenesis of inflammatory bowel disease. Deucravacitinib is a novel, oral, selective, allosteric tyrosine kinase 2 inhibitor currently approved for the treatment of adults with moderate to severe plaque psoriasis.

methodsHere we describe 3 randomized, double-blind, placebo-controlled phase 2 studies of deucravacitinib in patients with moderately to severely active Crohn's disease (LATTICE-CD [NCT03599622]) or ulcerative colitis (LATTICE-UC [NCT03934216] and IM011-127 [NCT04613518]). Patients were randomized to receive placebo or twice-daily deucravacitinib 3 or 6 mg (LATTICE-CD), 6 mg (LATTICE-UC), or 12 mg (IM011-127) for 12 weeks. Coprimary endpoints for LATTICE-CD were clinical remission and endoscopic response at week 12. The primary endpoint was clinical remission (per modified Mayo score) at week 12 for LATTICE-UC and clinical response (per modified Mayo score) at week 12 for IM011-127.

resultsA total of 239 (LATTICE-CD), 131 (LATTICE-UC), and 38 (IM011-127) patients were randomized. The primary endpoints were not met for all 3 studies, which resulted in early study termination for LATTICE-CD and IM011-127. High efficacy rates were observed in placebo groups throughout the studies. In all studies, the safety profile of deucravacitinib was consistent with the known safety profile observed in patients with psoriasis, and no new safety signals were observed.

conclusionsDeucravacitinib at multiple doses did not demonstrate significant clinical benefit vs placebo in moderately to severely active Crohn's disease or ulcerative colitis. Deucravacitinib was safe and well tolerated.

Indexed as

Colitis, UlcerativeCrohn DiseaseProtein Kinase InhibitorsAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedRemission InductionTreatment OutcomeProtein Kinase InhibitorsCrohn’s diseaseDeucravacitinibefficiacysafetyulcerative colitis

Identifiers

PMID40355364
PMCPMC12137900

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.