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Celiac DiseasePhase 2NCT02929316

Vedolizumab Induction May Prevent Celiac Enteritis

A Phase 2 study testing Vedolizumab in people with Celiac Disease, run by AGA Clinical Research Associates, LLC at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Celiac Disease
What is being tested?
Vedolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
2 sitesUnited States
Study dates
25 Jun 2018to 5 Oct 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients must meet the following criteria for study entry:
  • Adult patients with Celiac Disease (CD)
  • Without any additional co-morbidities
  • Normal renal and hepatic function
  • Diagnosis of CD established at least 6 months prior to trial with diagnostic serology, genetic profile, endoscopic appearance and histopathology report In histologic and serologic remission (defined as MARSH 0 and negative anti-tissue transglutaminase, etc.) following a gluten free diet
  • Naïve to treatment with vedolizumab
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  • Able and willing to provide written informed consent
  • Eligibility criteria for laboratory profiles - healthy patient normal laboratory reference values
  • WBC 4.5-12.0 k/UL
  • Platelet count- 140-415 k/UL
  • Hemoglobin- 11.0-17.4 %g/dL
  • Renal Function-
  • Creatinine- 0.5-1.3 mg/dL
  • BUN- 5-20 mg/dL
  • Hepatic Function
  • Albumin - 3.3-5.0 g/dL
  • INR- 0.9-1.1
  • AST- 0-37 U/L
  • ALT- 0-40 U/L
  • Total Bilirubin- 0.1-1.3 mg/dL
  • Alk Phos- 35-150 U/L

Who cannot join

  • Patients who meet any of the following criteria will be excluded from study entry:
  • Abnormal MARSH score on enrollment histopathology
  • Elevated celiac serologies (anti-tissue transglutaminase, etc.)
  • Current use of biologics or immunomodulators Adalimumab, infliximab, Ustekinumab, Golimumab, Tocilizumab, Certolizumab, Etanercept, Rituximab, Anakinra, Abatacept, Tofacitinib, Methotrexate, Azathioprine, 6-MP.
  • Current use of immunosuppressive therapy including intermittent systemic corticosteroids within two months of vedolizumab induction
  • History of intestinal lymphoma (MALToma, etc.)
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  • History of cancer including hematologic malignancy, solid tumors, carcinoma in situ, etc.
  • Pregnant or lactating
  • Fertile females will require at least one form of birth control
  • Lack of peripheral venous access
  • Inability to comply with study protocol, in the opinion of the investigator
  • Neurological conditions which may interfere with monitoring for PML
  • History of demyelinating disease or history of major neurological disease
  • History of alcohol, drug or chemical abuse < 6 months prior to screening
  • History of active tuberculosis (TB) or a positive screening test for latent mycobacterium tuberculosis infection
  • Positive PPD= > 10 mm or > 5mm in patients on 15 mg or more of prednisone
  • History of BCG vaccination should be screened using Quantiferon TB Gold test
  • An Indeterminate Quantiferon test will require a chest X-ray to rule out active TB and consultation with an infectious disease specialist to confirm the risk of latent
  • TB is low and that patients can be safely enrolled in the trial
  • History of recurrent opportunistic infections and/or of severe or disseminated viral infections
  • Active autoimmune disease
  • Active inflammatory bowel disease

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • AGA Clinical Research Associates, LLC

    Egg Harbor, New Jersey, 08234

  • Theresa Stevens

    Egg Harbor, New Jersey, 08234

Other trials in United States

About this study

Official title: Vedolizumab Induction May Prevent Celiac Enteritis After Gluten Challenge in Established Celiac Patients in Histological Remission

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)

Read the detailed description

Adult subjects with CD will be recruited through our clinic. All patients enrolled will have established CD diagnosed > 6 months. All patients will have history of abnormal MARSH score on initial duodenal biopsy at diagnosis and MARSH 0 on repeat biopsy following a gluten free diet (GFD). All patients will also have positive celiac serologies (anti-TTG, anti-gliadin, etc.) at diagnosis, as well as, positive HLA DQ2/DQ8 genetic profile. At enrollment, all patients will have negative celiac serologies, indicative of serologic remission on a gluten free diet. Female subjects of childbearing potential (does not include those with history of tubal ligation/surgical sterilization, hysterectomy and/or oophorectomy) who are sexually active with a non-sterilized male partners agree to routinely use adequate contraception from signing informed consent, during study process and for an additional 18 weeks after the last dose of vedolizumab. A male subject who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing informed consent throughout the duration of the study and for 18 weeks after the last dose.

Conditions
Celiac Disease
Being tested
Vedolizumab
Medical subject headings
Celiac Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VedolizumabDrug

    Also called Entyvio

    IV infusion week 0, 2 and 6

Study groups in NCT02929316
Study groupRoleWhat they receive
VedolizumabExperimentalVedolizumab (Entyvio) 300mg IV at week 0, 2 and 6
Receives: Drug: Vedolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Normal histopathology following induction dosing with vedolizumab

    Remission is defined in this study of negative celiac antibodies and normal duodenal biopsies

    Measured: 12 weeks

  2. Normal histopathology following induction dosing with vedolizumab after 2 week gluten challange

    Remission is defined in this study as negative celiac antibodies and normal duodenal biopsies

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2016 (estimated)
  2. Study start25 Jun 2018
  3. Primary completion5 Oct 2018
  4. Study completion5 Oct 2018

Why it stopped: Lack of enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02929316
Sponsor's protocol ID
IISR-2016-101481
Status last verified
Oct 2018
First submitted
5 Oct 2016
Last updated
10 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Green PH, Cellier C. Celiac disease. N Engl J Med. 2007 Oct 25;357(17):1731-43. doi: 10.1056/NEJMra071600. No abstract available.

    PubMed 17960014

  • Lionetti E, Castellaneta S, Francavilla R, Pulvirenti A, Tonutti E, Amarri S, Barbato M, Barbera C, Barera G, Bellantoni A, Castellano E, Guariso G, Limongelli MG, Pellegrino S, Polloni C, Ughi C, Zuin G, Fasano A, Catassi C; SIGENP (Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition) Working Group on Weaning and CD Risk. Introduction of gluten, HLA status, and the risk of celiac disease in children. N Engl J Med. 2014 Oct 2;371(14):1295-303. doi: 10.1056/NEJMoa1400697.

    PubMed 25271602

  • Lee SK, Lo W, Memeo L, Rotterdam H, Green PH. Duodenal histology in patients with celiac disease after treatment with a gluten-free diet. Gastrointest Endosc. 2003 Feb;57(2):187-91. doi: 10.1067/mge.2003.54.

    PubMed 12556782

  • Leffler DA, Schuppan D. Update on serologic testing in celiac disease. Am J Gastroenterol. 2010 Dec;105(12):2520-4. doi: 10.1038/ajg.2010.276.

    PubMed 21131921

  • Wahab PJ, Meijer JW, Mulder CJ. Histologic follow-up of people with celiac disease on a gluten-free diet: slow and incomplete recovery. Am J Clin Pathol. 2002 Sep;118(3):459-63. doi: 10.1309/EVXT-851X-WHLC-RLX9.

    PubMed 12219789

  • Vahedi K, Mascart F, Mary JY, Laberenne JE, Bouhnik Y, Morin MC, Ocmant A, Velly C, Colombel JF, Matuchansky C. Reliability of antitransglutaminase antibodies as predictors of gluten-free diet compliance in adult celiac disease. Am J Gastroenterol. 2003 May;98(5):1079-87. doi: 10.1111/j.1572-0241.2003.07284.x.

    PubMed 12809831

  • Kelly CP, Green PH, Murray JA, Dimarino A, Colatrella A, Leffler DA, Alexander T, Arsenescu R, Leon F, Jiang JG, Arterburn LA, Paterson BM, Fedorak RN; Larazotide Acetate Celiac Disease Study Group. Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study. Aliment Pharmacol Ther. 2013 Jan;37(2):252-62. doi: 10.1111/apt.12147. Epub 2012 Nov 19.

    PubMed 23163616

  • Leffler DA, Kelly CP, Abdallah HZ, Colatrella AM, Harris LA, Leon F, Arterburn LA, Paterson BM, Lan ZH, Murray JA. A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge. Am J Gastroenterol. 2012 Oct;107(10):1554-62. doi: 10.1038/ajg.2012.211. Epub 2012 Jul 24.

    PubMed 22825365

  • Leffler D, Schuppan D, Pallav K, Najarian R, Goldsmith JD, Hansen J, Kabbani T, Dennis M, Kelly CP. Kinetics of the histological, serological and symptomatic responses to gluten challenge in adults with coeliac disease. Gut. 2013 Jul;62(7):996-1004. doi: 10.1136/gutjnl-2012-302196. Epub 2012 May 22.

    PubMed 22619366

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vedolizumab in people with Celiac Disease, run by AGA Clinical Research Associates, LLC at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Normal histopathology following induction dosing with vedolizumab (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02929316, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.

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