Status:
WITHDRAWN
A Study of Guselkumab in Adult Participants With Celiac Disease
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Celiac Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of guselkumab compared to placebo in participants with celiac disease.
Eligibility Criteria
Inclusion
- Have a body mass index (BMI) 16 to 45 kilogram per meter square (kg/m\^2). Underweight participants (BMI 16 to 18 kg/m\^2) may only be included if in the opinion of the investigator a participant was underweight due to active celiac disease and thus, may benefit from therapy but yet not be at significantly increased risk due to severe malabsorption or other conditions
- Physician-diagnosed celiac disease with documented history of biopsy-proven celiac disease
- Self-reported to be on a gluten-free diet (GFD) for at least 11 consecutive months prior to enrollment and have the willingness to continue to adhere to the same GFD while on study
- Willing to take/ingest gluten-containing product at specific study timepoints only (if assigned to Module B)
- Willing to undergo up to 3 on-study esophagogastroduodenoscopy (EGD) with biopsies
Exclusion
- Has a history of chronic inflammatory gastrointestinal disease (example, inflammatory bowel disease, extensive colitis, ulcerative jejunitis, eosinophilic esophagitis)
- Has chronic infectious gastrointestinal illness, or acute infectious gastrointestinal illness within the 4-week period prior to screening
- Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of a non-melanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study intervention administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study intervention); known history of lymphoproliferative disease, including monoclonal gammopathy of unknown significance, lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly
- Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis or chronic non-remitting cystitis), or open, draining, or infected skin wounds or ulcers
- Has had previous treatment with guselkumab
Key Trial Info
Start Date :
June 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04704843
Start Date
June 17 2021
End Date
September 13 2021
Last Update
February 3 2025
Active Locations (4)
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1
Clinical Trials Network
Lancaster, California, United States, 93534
2
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States, 48047
3
West Michigan Clinical Research Center
Wyoming, Michigan, United States, 49519
4
Hightower Clinical
Oklahoma City, Oklahoma, United States, 73102