Status:
COMPLETED
Gluten Challenge Study in Celiac Disease Participants (MK-0000-402)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Celiac Disease
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
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 wit...
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...
Eligibility Criteria
Inclusion
- Participant must have documented diagnosis with celiac disease (CeD) by duodenal/jejunal biopsy at least 6 months prior to entrance into the study.
- Participant must be on a gluten-free diet (GFD) for at least the past 12 months.
- Female participants must not be pregnant or breastfeeding. Women of childbearing potential (WOCBP) must use an acceptable contraceptive method or abstain from heterosexual intercourse.
- 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.
- Has anti-tissue transglutaminase (anti-tTG) \<2x upper limit of normal (ULN) as measured by serology.
- 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.
- Have a body mass index (BMI) 18-35 kg/m\^2, inclusive.
Exclusion
- Has any chronic active gastrointestinal (GI) disease (e.g., 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.
- 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.
- 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.
- Participant has an estimated Glomerular Filtration Rate (eGFR) ≤80 mL/min/1.73 m\^2 at the screening visit based on the Cockcroft-Gault (CG) equation
- Has a history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or systemic allergic reaction to prescription or nonprescription drugs or food.
- Subject has a history of severe acute symptomatic reactions to sporadic gluten ingestion.
- Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV).
- Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
- Is on Coumadin™ or other anticoagulants.
- 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.
- 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.
- Has a corrected QT (QTc) interval ≥470 msec (for males) or ≥480 msec (for females).
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04054544
Start Date
August 28 2020
End Date
June 23 2021
Last Update
March 6 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital ( Site 0001)
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center ( Site 0002)
Boston, Massachusetts, United States, 02215