Evidence map›Paper›PMID 29846530›Full record

Trial reportJournal of Crohn's & colitis2018

A Phase 2, Randomized, Placebo-Controlled Study Evaluating Matrix Metalloproteinase-9 Inhibitor, Andecaliximab, in Patients With Moderately to Severely Active Crohn's Disease.

Stefan Schreiber, Corey A Siegel, Keith A Friedenberg, Ziad H Younes, Ursula Seidler, Bal R Bhandari, Ke Wang, Emily Wendt, Matt McKevitt, Sally Zhao and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of Crohn's & colitis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02405442 (A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Crohn's Disease), which is not on this map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
3.4field-weighted citation impact, top 7% 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.

NCT02405442 phase2terminatednot on this map

A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Crohn's Disease

TypeinterventionalSponsorGilead SciencesRan2015 to 2016Enrolled187ConditionsCrohn's DiseaseArmsAndecaliximab, Placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Proteases in intestinal health and disease.Nature reviews. Gastroenterology & hepatology · 2026
    Review
  5. Article
  6. Article
  7. Review
  8. Challenges and opportunities in inflammatory bowel disease: from current therapeutic strategies to organoid-based models.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2024
    Review
  9. Neutrophils: from IBD to the gut microbiota.Nature reviews. Gastroenterology & hepatology · 2024
    Review
  10. Matrix metalloproteinases in intestinal fibrosis.Journal of Crohn's & colitis · 2024
    Review
  11. Selected Cytokines and Metalloproteinases in Inflammatory Bowel Disease.International journal of molecular sciences · 2023
    Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 2 countries.

Stefan SchreiberChristian-Albrechts-University Kiel, UKSH, Kiel, Germany.
Corey A SiegelDartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
Keith A FriedenbergGreat Lakes Gastroenterology, Mentor, OH, USA.
Ziad H YounesGastroOne, Germantown, TN, USA.
Ursula SeidlerHannover Medical School, Hannover, Germany.
Bal R BhandariDelta Research Partners, Monroe, LA, USA.
Ke WangGilead Sciences, Inc., Foster City, CA, USA.
Emily WendtGilead Sciences, Inc., Foster City, CA, USA.
Matt McKevittGilead Sciences, Inc., Foster City, CA, USA.
Sally ZhaoGilead Sciences, Inc., Foster City, CA, USA.
John S SundyGilead Sciences, Inc., Foster City, CA, USA.
Scott D LeeUniversity of Washington, Seattle, WA, USA.
Edward V LoftusMayo Clinic, Rochester, MN, USA.
Gilead Sciences (United States) · USDartmouth–Hitchcock Medical Center · USGastro One (United States) · USKiel University · DELake Research Partners · USMayo Clinic in Arizona · USMedizinische Hochschule Hannover · DEUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsMatrix metalloproteinase-9 [MMP9] is implicated in the pathogenesis of Crohn's disease and may serve as a potential biomarker. A phase 2 trial was conducted to examine the efficacy and safety of the anti-MMP9 antibody andecaliximab [GS-5745] in patients with moderately to severely active Crohn's disease.

methodsPatients were randomized 1:2:2:2 to receive subcutaneous injections of placebo weekly [QW], andecaliximab 150 mg every 2 weeks [Q2W], andecaliximab 150 mg QW, or andecaliximab 300 mg QW.The co-primary study efficacy endpoints were evaluation of a clinical response, defined as liquid or very soft stool frequency and abdominal pain composite [from Patient-Reported Outcome 2] score ≤ 8 at week 8, and an endoscopic response, defined as a ≥ 50% reduction from baseline in the Simple Endoscopic Score for Crohn's Disease, following 8 weeks of treatment.

resultsA total of 187 participants were randomized to treatment; 53 participants were randomized to each andecaliximab treatment group and 28 participants were randomized to placebo. Proportions of patients receiving andecaliximab were not different from proportions of patients receiving placebo based on clinical and endoscopic response and Crohn's disease activity index-defined remission at week 8. Rates of adverse events were comparable among the andecaliximab and placebo groups.

conclusionsEight weeks of induction treatment with 150 mg andecaliximab Q2W, 150 mg andecaliximab QW, or 300 mg andecaliximab QW in patients with Crohn's disease did not induce a clinically meaningful symptomatic or endoscopic response. Andecaliximab was well tolerated. CLINICAL

trial registrationClinicalTrials.gov NCT02405442.

Indexed as

AdultAntibodies, Monoclonal, HumanizedCrohn DiseaseDouble-Blind MethodDrug Administration ScheduleFemaleHumansInjections, SubcutaneousMaleMatrix Metalloproteinase 9Matrix Metalloproteinase InhibitorsMiddle AgedTreatment OutcomeandecaliximabAntibodies, Monoclonal, HumanizedMatrix Metalloproteinase 9Matrix Metalloproteinase InhibitorsCrohn’s diseaseinflammationmatrix metalloproteinase-9

Identifiers

PMID29846530
PMCPMC6113705
OpenAlexW2807341995

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.