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A Study of Guselkumab in Adult Participants With Celiac Disease

Recruiting at 27 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Janssen Research & Development, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

How is the drug Guselkumab different from other treatments?

Guselkumab is unique because it specifically targets the interleukin-23 (IL-23) pathway, which plays a key role in inflammatory processes, making it different from other treatments that may target broader immune pathways. This specificity can lead to more targeted treatment with potentially fewer side effects.12345

Who Is on the Research Team?

JR

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

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
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous infusion of guselkumab or placebo every 4 weeks through Week 8, followed by subcutaneous injection at Week 12

12 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Guselkumab
  • Placebo
How Is the Trial Designed?
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.

Guselkumab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Tremfya for:
  • Moderate to severe plaque psoriasis
  • Psoriatic arthritis
  • Moderately to severely active ulcerative colitis
🇪🇺
Approved in European Union as Tremfya for:
  • Moderate to severe plaque psoriasis
  • Psoriatic arthritis
  • Moderately to severely active ulcerative colitis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

Long-term limb allograft survival using anti-CD40L antibody in a murine model. [2022]
Preemptive administration of human αβ T cell receptor-targeting monoclonal antibody GZ-αβTCR potently abrogates aggressive graft-versus-host disease in vivo. [2015]
Treatment of acute graft-versus-host disease with methylprednisolone and cyclosporine with or without an anti-interleukin-2 receptor monoclonal antibody. A multicenter phase III study. [2021]
Development and Characterization of Novel Monoclonal Antibodies Against Human DNAM-1. [2018]
Anti-LFA-1 or rapamycin overcome costimulation blockade-resistant rejection in sensitized bone marrow recipients. [2022]
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