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Gluten Challenge Study in Celiac Disease Participants (MK-0000-402)

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ClinicalTrials.gov Identifier: NCT04054544
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This is a gluten challenge study to characterize peripheral blood and intestinal gluten specific cluster of differentiation 4 glycoprotein (CD4+) thymus lymphocyte (T cell) subsets in participants with Celiac Disease

Condition or disease Intervention/treatment Phase
Celiac Disease Dietary Supplement: Gluten powder 4g Early Phase 1

Detailed Description:
This is a multi-site, open-label gluten challenge study to characterize peripheral blood and intestinal gluten specific CD4+ T cell subsets in participants with celiac disease (CeD). Participants will receive 8 grams (g) of gluten daily for 13 consecutive days. Blood samples will be taken at pre-dose, Day 6, and Day 14. Duodenal biopsy samples will also be collected on Day 14. Participants will also complete a symptom diary.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Experimental study to determine blood and duodenal T cell changes following administration of a 8 g gluten challenge daily for 13 days in participants with celiac disease
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Gluten Challenge Study to Characterize Peripheral Blood and Intestinal Gluten-specific CD4+ T Cell Subsets in Patients With Celiac Disease
Actual Study Start Date : August 28, 2020
Estimated Primary Completion Date : June 23, 2021
Estimated Study Completion Date : June 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Experimental: Gluten challenge
Participants will receive a gluten 4 g powder twice daily (BID), for 13 consecutive days
Dietary Supplement: Gluten powder 4g
Gluten powder 4g oral BID




Primary Outcome Measures :
  1. α-gliadin and ω-gliadin-reactive CD4+ T cells in peripheral blood before gluten challenge [ Time Frame: Baseline ]
    Percentage of α-gliadin and ω-gliadin-reactive CD+4 T cells expressing known activation and inhibitory receptors including but not limited to: CD25 (IL-2R), CD95 (FasR), CD279 (PD-1), TGFb1R, and IL- 27R)) in peripheral blood cells before gluten challenge.

  2. α-gliadin and ω-gliadin-reactive CD4+ T cells in peripheral blood after gluten challenge [ Time Frame: Day 14 ]
    Percentage of α-gliadin and ω-gliadin-reactive CD+4 T cells expressing known activation and inhibitory receptors including but not limited to: CD25 (IL-2R), CD95 (FasR), CD279 (PD-1), TGFb1R, and IL- 27R)) in peripheral blood cells after gluten challenge.

  3. α-gliadin and ω-gliadin-reactive CD4+ T cells in duodenal biopsies after gluten challenge [ Time Frame: Day 14 ]
    Percentage of α-gliadin and ω-gliadin-reactive CD+4 T cells expressing known activation and inhibitory receptors including but not limited to: CD25 (IL-2R), CD95 (FasR), CD279 (PD-1), TGFb1R, and IL- 27R)) in duodenal cells after gluten challenge.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant must have documented diagnosis with celiac disease (CeD) by duodenal/jejunal biopsy at least 6 months prior to entrance into the study.
  2. Participant must be on a gluten-free diet (GFD) for at least the past 12 months.
  3. Female participants must not be a woman of childbearing potential (WOCBP), pregnant or breastfeeding
  4. Must be Human leukocyte antigen (HLA)-DQ2.5 positive, assessed at screening. If participants have already been genotyped, results from previous testing may be used in lieu of genotyping at screening.
  5. Has anti-tissue transglutaminase (anti-tTG) <2x upper limit of normal (ULN) as measured by serology.
  6. Be judged to be in good health based on medical history, physical examination (including a targeted neurological exam), versus (vs.) measurements and electrocardiogram (ECG) performed prior to treatment allocation.
  7. Have a body mass index (BMI) 18-35 kg/m2, inclusive.

Exclusion Criteria:

  1. Has any chronic active gastrointestinal (GI) disease (eg, clinically active CeD despite being on GFD for past 12 months, Crohn's disease, ulcerative colitis, lymphocytic colitis). Inactive, stable/well-treated lactose intolerance, Fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) intolerance, gastroesophageal reflux disease (GERD), and irritable bowel syndrome (IBS) are allowed.
  2. Has clinically active endocrine, gastrointestinal (other than CeD), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a remote history of uncomplicated medical events or stable medical diseases with no symptoms and stable treatment for the past >3 months may be enrolled in the study at the discretion of the investigator.
  3. Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder within the last 5 years. Participants who have had situational depression may be enrolled in the study at the discretion of the investigator.
  4. Participant has an estimated Glomerular Filtration Rate (eGFR) ≤80 mL/min/1.73 m2 at the screening visit based on the Cockcroft-Gault (CG) equation
  5. Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or systemic allergic reaction to prescription or nonprescription drugs or food.
  6. Subject has a history of severe acute symptomatic reactions to sporadic gluten ingestion.
  7. Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV).
  8. Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
  9. Is on Coumadin™ or other anticoagulants.
  10. Is unable to refrain from or anticipates the use of systemic anti-inflammatory, immunosuppressive, or immunomodulatory medications, which may include ibuprofen > 2400 mg/day, naproxen >750 mg/day, prednisone >10 mg/day, or methylprednisolone > 8 mg/day, within 48 hours prior to the start of and throughout the entire gluten challenge.
  11. Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit. The window will be derived from the date of the last visit in the previous study.
  12. Has a corrected QT (QTc) interval ≥470 msec (for males) or ≥480 msec (for females).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054544


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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United States, Massachusetts
Massachusetts General Hospital ( Site 0001) Completed
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center ( Site 0002) Recruiting
Boston, Massachusetts, United States, 02215
Contact: Study Coordinator    617-667-8266      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck, Sharpe & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT04054544    
Other Study ID Numbers: 0000-402
MK-0000-402 ( Other Identifier: Merck Protocol Number )
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme Corp.:
Celiac disease
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases