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Monoclonal Antibodies
A Study of Guselkumab in Adult Participants With 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
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 moreSecondary 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 moreSide effects data
From 2020 Phase 4 trial • 1027 Patients • NCT035733231%
Nasopharyngitis
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
1,007 Previous Clinical Trials
6,402,370 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
772 Previous Clinical Trials
3,980,397 Total Patients Enrolled