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Monoclonal Antibodies

Guselkumab for Celiac Disease

Phase 1

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 28

Summary

This trial tests the safety and tolerability of guselkumab in people with celiac disease. Guselkumab aims to reduce the immune system's harmful reaction to gluten. It has been previously tested for moderate to severe psoriasis.

Eligible Conditions

Celiac Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests

Number of Participants with Clinically Significant Abnormalities in Vital Signs

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

+1 more

Secondary study objectives

Change from Baseline in Celiac Disease Symptom Diary (CDSD) Scores

Change from Baseline in Celiac Disease-Gastrointestinal Symptom Rating Scale (CeD-GSRS) Score

Change from Baseline in Clinical Biomarker Fecal Calprotectin

+7 more

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323

Nasopharyngitis

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Ixekizumab Post-Treatment Follow Up

Ixekizumab

Guselkumab

Guselkumab Post-Treatment Follow Up

Trial Design

2Treatment groups

Experimental Treatment

Group I: Module B (With Gluten-Challenge): Guselkumab or PlaceboExperimental Treatment2 Interventions

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 II: Module A (Without Gluten-Challenge): Guselkumab or PlaceboExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Guselkumab

2015

Completed Phase 4

~6080

Placebo

1995

Completed Phase 3

~2670