A Study of Guselkumab in Adult Participants With Celiac Disease

NCT ID: NCT04704843

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-17
• Study Completion Date: 2021-09-13

Brief Summary

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

Conditions

Celiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Module A (Without Gluten-Challenge): Guselkumab or Placebo

Participants in Module A (without gluten-challenge) will receive intravenous (IV) infusion of guselkumab or matching placebo as induction dose at every 4 weeks through Week 8 followed by subcutaneous (SC) injection of guselkumab or matching placebo at Week 12.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

Guselkumab will be administered as IV infusion (induction dose) and SC injection.

Placebo

Intervention Type: DRUG

Matching placebo to guselkumab will be administered as IV infusion (induction dose) and SC injection.

Module B (With Gluten-Challenge): Guselkumab or Placebo

Participants in Module B (with gluten-challenge) will receive IV infusion of guselkumab or matching placebo as induction dose at every 4 weeks through Week 8 followed by SC injection of guselkumab or matching placebo at Week 12.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

Guselkumab will be administered as IV infusion (induction dose) and SC injection.

Placebo

Intervention Type: DRUG

Matching placebo to guselkumab will be administered as IV infusion (induction dose) and SC injection.

Interventions

Guselkumab

Guselkumab will be administered as IV infusion (induction dose) and SC injection.

Intervention Type: DRUG

Placebo

Matching placebo to guselkumab will be administered as IV infusion (induction dose) and SC injection.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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

Countries

United States

Other Identifiers

2020-003539-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

64304500CLD1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108914

Identifier Type: -

Identifier Source: org_study_id