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NCT02929316

Vedolizumab Induction May Prevent Celiac Enteritis

Terminated Phase 2 Last updated 10 October 2018
What this trial tests

Phase 2 trial testing Vedolizumab in Celiac Disease in 1 participant. Terminated before completion.

Timeline
25 June 2018
Primary endpoint
5 October 2018
5 October 2018

Quick facts

Lead sponsorAGA Clinical Research Associates, LLC
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment1
Start date25 June 2018
Primary completion5 October 2018
Estimated completion5 October 2018
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

AGA Clinical Research Associates, LLC

Who can join

Adults 18 to 75, any sex, with Celiac Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Celiac disease (CD) is characterized as an autoimmune disorder whereby gluten (a protein found in wheat, barley, rye, malt) induces an immunological response in genetically susceptible individuals. The prevalence of CD has been estimated to affect 0.5-1% of the population worldwide. Long term sequelae are numerous and include risk of lymphoma, malabsorption leading to weight loss, anemia, multiple vitamin deficiencies, osteoporosis/osteopenia, secondary autoimmunity, etc. (1)

Publications & conference data

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

  1. Evolving Therapy for Celiac Disease.
    Yoosuf S, Makharia GK. · · 2019 · cited 54× · PMID 31157194 · DOI 10.3389/fped.2019.00193
  2. Celiac disease: mechanisms and emerging therapeutics.
    Besser HA, Khosla C. · · 2023 · cited 31× · PMID 37839914 · DOI 10.1016/j.tips.2023.09.006
  3. New Developments in Celiac Disease Treatment.
    Machado MV. · · 2023 · cited 21× · PMID 36674460 · DOI 10.3390/ijms24020945
  4. Gliadin Sequestration as a Novel Therapy for Celiac Disease: A Prospective Application for Polyphenols.
    Van Buiten CB, Elias RJ. · · 2021 · cited 14× · PMID 33435615 · DOI 10.3390/ijms22020595
  5. Beyond the gluten-free diet: Innovations in celiac disease therapeutics.
    Massironi S, Franchina M, Elvevi A, Barisani D. · · 2024 · cited 9× · PMID 39493330 · DOI 10.3748/wjg.v30.i38.4194
  6. Upcoming Treatments in Celiac Disease: From Luminal Enzymes to Oral Immune Tolerance.
    Taavela J, Elli L, Bouma G, Tye-Din JA, et al · · 2026 · PMID 42033586 · DOI 10.1002/ueg2.70222

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Data sources for this page

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/NCT02929316.

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