A Study of Guselkumab in Adult Participants With Celiac Disease

Janssen Research & Development, LLC

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Celiac Disease

Interventions

GuselkumabDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Outcomes

Primary Outcomes

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline.

Time frame: Up to Week 28

Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)

TEAEs are AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline. A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

Time frame: Up to Week 28

Number of Participants with Clinically Significant Abnormalities in Vital Signs

Number of participants with clinically significant vital signs abnormalities including temperature, pulse/heart rate, respiratory rate, and blood pressure (systolic and diastolic) (supine) will be reported.

Time frame: Up to Week 28

Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests

Number of participants with clinically significant abnormalities in laboratory safety tests will be reported.

Time frame: Up to Week 28

Secondary Outcomes

Change from Baseline in Villus Height to Crypt Depth (Vh:Cd) Ratio

Change from baseline in Vh:Cd ratio will be reported.

Data from ClinicalTrials.gov

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