A Study of Guselkumab in Adult Participants With Celiac Disease

Part of paid clinical trials in Lancaster, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04704843
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab — DRUG
    Guselkumab will be administered as IV infusion (induction dose) and SC injection.
  • Placebo — DRUG
    Matching placebo to guselkumab will be administered as IV infusion (induction dose) and SC injection.

Study Details

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

Key Dates

Start date
Jun 17, 2021
Status verified
Jan 2025
Primary completion
Sep 13, 2021
Completion
Sep 13, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 28 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Clinical Trials NetworkLancasterCalifornia93534-
Clinical Research Institute of Michigan, LLCChesterfieldMichigan48047-
West Michigan Clinical Research CenterWyomingMichigan49519-
Hightower ClinicalOklahoma CityOklahoma73102-

Find similar trials in Lancaster, CA

By condition
Celiac disease
By specialty
GastroenterologyAutoimmune disease
By research site
Clinical Trials Network· Lancaster, CAClinical Research Institute of Michigan, LLC· Chesterfield, MIWest Michigan Clinical Research Center· Wyoming, MIHightower Clinical· Oklahoma City, OK

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