A Study of Guselkumab in Adult Participants With Celiac Disease

Recruiting at 27 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Disqualifiers: Chronic gastrointestinal disease, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

Trial Summary

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. ^{1 2 3 4 5}

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.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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

Timeline

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)

Treatment Details

Interventions

• Guselkumab
• Placebo

Participant Groups

Group I: Module B (With Gluten-Challenge): Guselkumab or Placebo Experimental Treatment 2 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 Placebo Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-term limb allograft survival using anti-CD40L antibody in a murine model. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Preemptive administration of human αβ T cell receptor-targeting monoclonal antibody GZ-αβTCR potently abrogates aggressive graft-versus-host disease in vivo. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. United States pubmed.ncbi.nlm.nih.gov

Development and Characterization of Novel Monoclonal Antibodies Against Human DNAM-1. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Anti-LFA-1 or rapamycin overcome costimulation blockade-resistant rejection in sensitized bone marrow recipients. [2022]