Guselkumab for Celiac Disease

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and tolerability of guselkumab, an immunotherapy, for individuals with celiac disease. In this condition, ingesting gluten triggers an immune response that harms the small intestine. Participants will receive either guselkumab or a placebo to assess treatment tolerance. Some participants will consume gluten during specific study phases to evaluate the treatment's effects, while others will not. Ideal candidates have a celiac disease diagnosis, adhere to a strict gluten-free diet, and are willing to undergo the medical procedures and conditions outlined in the study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive it.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that guselkumab is generally well-tolerated by individuals with conditions such as psoriasis and psoriatic arthritis. Serious side effects rarely occur, but some individuals have experienced allergic reactions, including anaphylaxis, a severe reaction that might require hospital care. The treatment is unlikely to cause immediate harm after administration. Since guselkumab is already approved for conditions like psoriatic arthritis, extensive safety information is available. However, its effects on celiac disease are still under study, so more specific information for this condition may be necessary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for celiac disease?

Most treatments for celiac disease involve a strict gluten-free diet, which can be challenging to maintain and doesn't address underlying immune responses. Guselkumab is unique because it targets interleukin-23 (IL-23), a protein involved in inflammation, which might offer a new way to manage celiac disease by directly modulating the immune system. Researchers are excited about this approach because it could provide relief for patients who struggle with dietary restrictions and continue to experience symptoms despite following a gluten-free diet. By potentially addressing the root cause of inflammation, guselkumab may offer a more effective treatment option for those with celiac disease.

What evidence suggests that guselkumab might be an effective treatment for celiac disease?

Research suggests that guselkumab might help with celiac disease by reducing the immune system's harmful reaction to gluten. This medication already treats psoriasis effectively, lessening symptoms over 9–12 months. Researchers hope it could similarly target the immune system in celiac disease. Although direct proof for celiac disease is not yet available, early results in other conditions are promising. In this trial, participants will receive either guselkumab or a placebo to determine its potential benefits for people with celiac disease. ^{6 7 8 9 10}

Who Is on the Research Team?

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

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?

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+

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

Janssen Research & Development, LLC

Chief Medical Officer since 2014

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

Citations

1. withpower.com withpower.com/trial/phase-1-celiac-disease-5-2021-21491

A Study of Guselkumab in Adult Participants With Celiac ... 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 ...

2. ctv.veeva.com ctv.veeva.com/study/a-study-of-guselkumab-in-adult-participants-with-celiac-disease

A Study of Guselkumab in Adult Participants With Celiac ... The purpose of this study is to evaluate the safety and tolerability of guselkumab compared to placebo in participants with celiac disease.

3. springermedicine.com springermedicine.com/celiac-disease/ueg-week-2025/antigen-specific-tolerance-approach-offers-treatment-hope/51547004

UEG Week 2025 | Antigen-specific tolerance approach ... The trial included 36 patients with HLA-DQ2.5-positive celiac disease who were following a gluten-free diet and had a rapid interleukin (IL)- ...

4. europeanpharmaceuticalreview.com europeanpharmaceuticalreview.com/news/75934/experimental-drug-gluten-gluten-free/

Experimental drug eases effects of gluten for coeliac patients The results show that AMG 714 reduced gluten-triggered effects in each of the two groups receiving the drug, compared to placebo. While AMG 714 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9884731/

Real-World Effectiveness of 9–12 Months of Guselkumab ... This real-world study showed that patients with moderate-to-severe psoriasis who received 9–12 months of persistent guselkumab therapy experienced improvements ...

6. tremfya.com tremfya.com/important-safety-information/

TREMFYA® (guselkumab) TREMFYA® is a prescription medicine used to treat adults with moderately to severely active Crohn's disease. IMPORTANT SAFETY INFORMATION. What is the most ...

7. iwaichem.com iwaichem.com/wp-content/uploads/GUS-FD-TRE_SDS.pdf

SAFETY DATA SHEET Based on composition, the mixture has low acute toxicity and no adverse effects for human health are expected under applicable conditions of exposure sodium ...

8. tremfyahcp.com tremfyahcp.com/psoriatic-arthritis/safety/

Safety Profile In Active PsA | TREMFYA® (guselkumab) HCP Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of TREMFYA®. Some cases required hospitalization. If a serious ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/761061s009lbl.pdf

TREMFYA® (guselkumab) injection, for subcutaneous use No overall differences in safety or effectiveness were observed between older and younger subjects who received TREMFYA.

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37906417/

Long-Term Safety of Guselkumab in Patients with Psoriatic ... Guselkumab was well tolerated and efficacious across individual pivotal clinical studies in adults with moderate-to-severe psoriasis and/or active psoriatic ...