Evidence map›Paper›PMID 41003640›Full record

Trial reportInflammatory bowel diseases2026

Long-Term Ozanimod Therapy in Patients With Moderately Active Ulcerative Colitis After Failure of 5-Aminosalicylic Acid.

Andres Yarur, Peter Irving, Britta Siegmund, Marla C Dubinsky, Ashwin N Ananthakrishnan, Miguel Regueiro, Ryan C Ungaro, Timothy Ritter, Hiroshi Nakase, Zhaohui Liu and 5 more

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Inflammatory bowel diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT02435992 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

TypeinterventionalSponsorCelgeneRan2015 to 2020Enrolled1,012ConditionsUlcerative ColitisArmsRPC1063, Placebo
NCT02531126 phase3completednot on this map

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

TypeinterventionalSponsorCelgeneRan2015 to 2024Enrolled877ConditionsUlcerative ColitisArmsRPC1063
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Andres YarurCedars-Sinai Medical Center, Los Angeles, CA 90048, United States.ORCID 0000-0003-2293-5555
Peter IrvingGuy's and St Thomas' NHS Foundation Trust, London SE1 7EH, United Kingdom.ORCID 0000-0003-0972-8148
Britta SiegmundDepartment of Gastroenterology, Infectious Diseases and Rheumatology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, 10117 Berlin, Germany.ORCID 0000-0002-0055-958X
Marla C DubinskySusan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Ashwin N AnanthakrishnanMassachusetts General Hospital, Boston, MA 02114, United States.
Miguel RegueiroCleveland Clinic, Cleveland, OH 44195, United States.ORCID 0000-0002-7681-8111
Ryan C UngaroIcahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Timothy RitterGI Alliance, Southlake, TX 76092, United States.
Hiroshi NakaseSapporo Medical University, Sapporo, Hokkaido 060-8556, Japan.
Zhaohui LiuBristol Myers Squibb, Lawrence Township, NJ 08648, United States.
Dimpy MehraBristol Myers Squibb, Lawrence Township, NJ 08648, United States.
Mark T OstermanBristol Myers Squibb, Lawrence Township, NJ 08648, United States.
Anjali JainBristol Myers Squibb, Lawrence Township, NJ 08648, United States.
David T RubinInflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL 60637, United States.
Toshifumi HibiCenter for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo 108-8642, Japan.

Funding

AbbVieBristol Myers Squibb
6 · The paper itself

Abstract

backgroundWe evaluated the efficacy and safety of ozanimod after 5-aminosalicylic acid (5-ASA) failure in advanced therapy (AT)-naive patients with moderate ulcerative colitis (UC) in True North and its open-label extension (OLE).

methodsTrue North was a randomized, 52-week, phase 3 trial with an optional OLE. Efficacy was assessed in True North and the OLE; safety was assessed through OLE week 190.

resultsOverall, 203 AT-naive True North patients had moderate UC (Mayo endoscopic subscore of 2 + modified Mayo score of 4-6 + rectal bleeding subscore ≥1). Of these, 139 were also immunomodulator-naive and not receiving corticosteroids (5-ASA-exposed only) at baseline. Patients with moderate UC receiving ozanimod vs placebo achieved greater efficacy rates for all week 10 and week 52 outcomes, regardless of prior immunomodulator/corticosteroid use (eg, week 10 clinical remission: AT-naive = 36.8% vs 10.6%; 5-ASA-exposed only = 37.9% vs 17.2%). Higher symptomatic response rates were achieved by week 2 with ozanimod in AT-naive patients with moderate UC vs the overall AT-naive population (50.5% vs 38.7%); similar trends were observed in patients exposed only to 5-ASA. Efficacy was maintained through OLE week 190 in patients who entered OLE as True North week 52 ozanimod clinical responders. Of those entering OLE as True North week 10 ozanimod clinical nonresponders, 69.0% of AT-naive patients and 68.4% of patients exposed only to 5-ASA achieved symptomatic response by week 5. No new safety signals emerged.

conclusionsOzanimod was safe, effective, and durable up to ∼5 years in AT-naive patients with moderate UC who failed conventional therapy. ClinicalTrials.gov: NCT02435992, NCT02531126.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalColitis, UlcerativeIndansMesalamineOxadiazolesSphingosine 1 Phosphate Receptor ModulatorsAdultAgedDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedPrognosisTreatment FailureAnti-Inflammatory Agents, Non-SteroidalIndansMesalamineOxadiazolesozanimodSphingosine 1 Phosphate Receptor Modulatorsadvanced therapy–naiveozanimodulcerative colitis

Identifiers

PMID41003640
PMCPMC12759051

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.