A Study of Guselkumab in Adult Participants With Celiac Disease

Withdrawn before enrolling · Phase 1 · Has a placebo group

Conditions studied: Celiac Disease

In brief

The purpose of this study is to evaluate the safety and tolerability of guselkumab compared to placebo in participants with celiac disease.

Key facts

Study ID: NCT04704843
Run by: Janssen Research & Development, LLC
People needed: 0
Starts: 2021-06-17
Expected to finish: 2021-09-13
Last updated by the study team: 2025-02-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Clinical Trials Network — Lancaster, California, United States
Clinical Research Institute of Michigan, LLC — Chesterfield, Michigan, United States
West Michigan Clinical Research Center — Wyoming, Michigan, United States
Hightower Clinical — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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