Guselkumab for Celiac Disease
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.12345
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.678910
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous infusion of guselkumab or placebo every 4 weeks through Week 8, followed by subcutaneous injection at Week 12
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Guselkumab
- Placebo
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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:
- Moderate to severe plaque psoriasis
- Psoriatic arthritis
- Moderately to severely active ulcerative colitis
- 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
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
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 ...
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/51547004UEG 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 ...
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 ...
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 ...
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 ...
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 ...
TREMFYA® (guselkumab) injection, for subcutaneous use
No overall differences in safety or effectiveness were observed between older and younger subjects who received TREMFYA.
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 ...
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