Evidence map›Paper›PMID 26721935›Full record

Trial reportJournal of Crohn's & colitis2016

Eldelumab [Anti-IP-10] Induction Therapy for Ulcerative Colitis: A Randomised, Placebo-Controlled, Phase 2b Study.

William J Sandborn, Jean-Frédéric Colombel, Subrata Ghosh, Bruce E Sands, Gerald Dryden, Xavier Hébuterne, Rupert W Leong, Brian Bressler, Thomas Ullman, Peter L Lakatos and 3 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of Crohn's & colitis, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01294410 (A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis), which is not on this map. Cited by 30 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 3 pooled it
4.9field-weighted citation impact, top 4% of its field
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.

NCT01294410 phase2completednot on this map

A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis (UC)

TypeinterventionalSponsorBristol-Myers SquibbRan2011 to 2014Enrolled305ConditionsColitis, UlcerativeArmsPlacebo, Anti-IP-10 Antibody
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 3 syntheses or guidelines pooled it, 73 citations in OpenAlex.

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  9. Mucosal Responses to Type II Interferon in IBD.Inflammatory bowel diseases · 2025
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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

13 authors at 10 institutions in 6 countries.

William J SandbornInflammatory Bowel Disease Center, University of California San Diego, La Jolla, CA, USA wsandborn@ucsd.edu.
Jean-Frédéric ColombelDr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Subrata GhoshDepartment of Medicine, University of Calgary, Calgary, AB, Canada.
Bruce E SandsDr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Gerald DrydenDivision of Gastroenterology, Hepatology, and Nutrition, University of Louisville School of Medicine, Louisville, KY, USA.
Xavier HébuterneFaculté de Médecine, Université de Nice-Sophia Antipolis, Hôpital de l'Archet, Nice, France.
Rupert W LeongConcord Hospital, Gastroenterology and Liver Services, University of New South Wales, Sydney, Australia.
Brian BresslerDivision of Gastroenterology, St Paul's Hospital, Vancouver, BC, Canada.
Thomas UllmanDr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Peter L Lakatos1st Department of Medicine, Semmelweis University, Budapest, Hungary.
Walter ReinischDepartment of Internal Medicine III, Medical University of Vienna, Vienna, Austria, and McMaster University, Department of Internal Medicine, Hamilton, ON, Canada.
Li-An XuBristol-Myers Squibb, Lawrenceville, NJ, USA.
Allison LuoFormerly of Bristol-Myers Squibb, Lawrenceville, NJ, USA.
Icahn School of Medicine at Mount Sinai · USBristol-Myers Squibb (United States) · USMcMaster University · CASemmelweis University · HUSt. Paul's Hospital · CAUniversité Côte d'Azur · FRUniversity of Calgary · CAUniversity of California, San Diego · USUniversity of Louisville · USUNSW Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsInterferon-γ-inducible protein-10 [IP-10] mediates immune cell trafficking from the circulation to the inflamed colon and decreases gut epithelial cell survival. IP-10 expression is increased in patients with ulcerative colitis [UC]. We report efficacy and safety results from a dose-ranging induction study of eldelumab, a fully human monoclonal antibody to IP-10, in moderately to severely active UC.

methodsA total of 252 adults with UC [Mayo score ≥ 6 and endoscopic subscore ≥ 2] were randomised 1:1:1 to placebo or eldelumab 15 or 25 mg/kg administered intravenously on Days 1 and 8 and every other week thereafter. The primary endpoint was clinical remission [Mayo score ≤ 2; no individual subscale score > 1] at Week 11. Key secondary endpoints included Mayo score clinical response and mucosal healing at Week 11.

resultsNeither eldelumab 15 or 25 mg/kg resulted in significant increases vs placebo in the proportion of patients achieving Week 11 clinical remission. Remission and response rates were 17.6% and 47.1% with eldelumab 25mg/kg, 13.1% and 44.0% with eldelumab 15mg/kg, and 9.6% and 31.3% with placebo. Clinical remission and response rates were higher in anti-tumour necrosis factor [TNF]-naïve patients treated with eldelumab compared with placebo. Eldelumab treatment was well tolerated and no immunogenicity was observed.

conclusionsThe primary endpoint was not achieved with induction treatment with eldelumab 15 or 25 mg/kg in patients with UC. Trends towards clinical remission and response were observed in the overall population and were more pronounced in anti-TNF naïve patients. Eldelumab safety signals were consistent with those reported previously [ClinicalTrials.gov number, NCT01294410].

Indexed as

AdolescentAdultAgedAntibodies, MonoclonalChemokine CXCL10Colitis, UlcerativeFemaleGastrointestinal AgentsHumansInfusions, IntravenousMaleMiddle AgedRemission InductionYoung AdultAntibodies, MonoclonalChemokine CXCL10CXCL10 protein, humaneldelumabGastrointestinal AgentsInflammatory bowel diseasesulcerative colitis

Identifiers

PMID26721935
PMCPMC4946756
OpenAlexW2237475190

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.