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Vedolizumab Induction May Prevent Celiac Enteritis

Sponsor
AGA Clinical Research Associates, LLC (Other)
Overall Status
Terminated
CT.gov ID
NCT02929316
Collaborator
Takeda (Industry)
1
Enrollment
2
Locations
1
Arm
3.4
Actual Duration (Months)
0.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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)

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Vedolizumab Induction May Prevent Celiac Enteritis After Gluten Challenge in Established Celiac Patients in Histological Remission
Actual Study Start Date :
Jun 25, 2018
Actual Primary Completion Date :
Oct 5, 2018
Actual Study Completion Date :
Oct 5, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vedolizumab

Vedolizumab (Entyvio) 300mg IV at week 0, 2 and 6

Drug: Vedolizumab
IV infusion week 0, 2 and 6
Other Names:
  • Entyvio

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Normal histopathology following induction dosing with vedolizumab [12 weeks]

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

    2. Normal histopathology following induction dosing with vedolizumab after 2 week gluten challange [12 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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

    • 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

    Exclusion Criteria:

    • 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.)

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AGA Clinical Research Associates, LLC Egg Harbor Township New Jersey United States 08234
    2 Theresa Stevens Egg Harbor Township New Jersey United States 08234

    Sponsors and Collaborators

    • AGA Clinical Research Associates, LLC
    • Takeda

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Barry Kaufman, MD, Director of Clinical Research, AGA Clinical Research Associates, LLC
    ClinicalTrials.gov Identifier:
    NCT02929316
    Other Study ID Numbers:
    • IISR-2016-101481
    First Posted:
    Oct 11, 2016
    Last Update Posted:
    Oct 10, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Celiac Disease
    Enteritis
    Vedolizumab

    Study Results

    No Results Posted as of Oct 10, 2018