Clinical Trial Awareness: 5 Ongoing Breakthrough Clinical Trials Advancing Celiac Disease Research
Celiac disease is often misunderstood as simply a dietary issue, but in reality, it’s a serious autoimmune condition that affects about 1 in 133 Americans. Even a crumb of gluten can cause significant harm, triggering painful symptoms and long-term intestinal damage. And while a strict gluten-free diet remains the only widely accepted treatment, it’s not a cure, and it doesn’t work for everyone. Many patients still suffer from accidental gluten exposure, slow healing, or persistent symptoms despite doing everything “right.” That’s why clinical research is not just important—it’s urgent.
At TrialX, we’re committed to helping patients access research more easily. We work with some of the world’s top pharmaceutical sponsors—including those ranked in the top 3 and top 10 globally—to bring breakthrough science closer to the people who need it most. Our platform makes it simpler to discover, join, and stay informed about clinical trials.
Here are five innovative clinical trials underway that are redefining what treatment for celiac disease could look like in the near future.
1. ASPIRION Study for Nonresponsive Celiac Disease
Sponsor- Sanofi
What it’s Testing and Why it Matters
This Phase 2 trial is evaluating Amlitelimab, a potential treatment for nonresponsive celiac disease (NRCD)—a condition where patients continue to experience symptoms despite strict gluten-free diets. The drug aims to improve intestinal healing and reduce the impact of accidental gluten exposure.
Why It Stands Out
This study targets a high-need subgroup of celiac patients who don’t respond to existing dietary management. If successful, it could introduce a first-of-its-kind therapy for NRCD.
What It Could Mean For Patients
Amlitelimab may offer hope to patients who are doing everything “right” but still suffer symptoms, improving quality of life and reducing long-term complications.
Location: On-site – Multiple global locations
The trial is actively recruiting at more than 100 global locations, including across the United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Czech Republic, Finland, France, Germany, Greece, Israel, Italy, Poland, Slovakia, Spain, Sweden, Turkey, and the United Kingdom.
View the trial and see if you’re eligible.
2. Ritlecitinib Trial to Prevent Gluten Reactions in Celiac Patients in Remission
Sponsor-Massachusetts General Hospital, in collaboration with Pfizer
What it’s Testing and Why it Matters
This study, led by Dr. Alessio Fasano at Massachusetts General Hospital, is exploring a new approach to help people with celiac disease stay protected even if they’re accidentally exposed to gluten. The trial is evaluating Ritlecitinib, an oral medication, to see if it can prevent gut damage and symptoms when gluten is reintroduced in patients currently in remission.
Participants must have biopsy-confirmed celiac disease, be between 18–75 years old, and have followed a gluten-free diet for at least six months. During the 21-day trial, they will consume either Ritlecitinib or a placebo, along with a controlled amount of gluten mixed in applesauce or hot chocolate.
Why It Stands Out
This trial takes a proactive approach to accidental gluten exposure, testing whether a daily oral medication can block immune responses before symptoms occur.
What It Could Mean for Patients
If successful, Ritlecitinib could lead to the first preventive treatment for gluten reactions, offering peace of mind and protection to millions managing celiac disease with diet alone.
Location
On-site at: Massachusetts General Hospital, Boston, MA, USA.
Learn more and explore participation here.
3. First-in-Human Trial of VTP-1000 to Build Gluten Tolerance
Sponsor: Barinthus Biotherapeutics
What It’s Testing and Why It Matters
This innovative Phase 1 clinical trial is evaluating VTP-1000, a potential immunotherapy designed to help people with celiac disease develop tolerance to gluten. The therapy uses self-assembling nanoparticles to deliver gluten-derived peptides and rapamycin—a strategy aimed at “teaching” the immune system not to overreact to gluten.
The study is primarily assessing safety, tolerability, and immune response to VTP-1000 in adults who are already following a well-controlled gluten-free diet. Some participants will also undergo a monitored gluten challenge to determine if the therapy can reduce harmful immune reactions.
Why It Stands Out
This is the first human trial of a new class of immunotherapy for celiac disease. If successful, VTP-1000 could mark a major step toward making dietary restrictions less rigid for millions of patients by training the immune system to tolerate gluten rather than react to it.
What It Could Mean for Patients
A future with fewer food restrictions and less anxiety around cross-contamination could be within reach. This therapy aims to reduce the physical and emotional burden of managing celiac disease, especially for those at risk from trace gluten exposure.
Location:
This study is being conducted at multiple on-site locations across the United States. Active recruiting sites include Los Angeles, California; Jacksonville and St. Petersburg, Florida; Baltimore, Maryland; Raleigh, North Carolina; Columbus, Ohio; and Austin, Texas. Additionally, the Mayo Clinic in Rochester, Minnesota, is listed as a site but has not yet begun recruiting.
4. Gluten Technology and Education for Celiac Health
Sponsor: Columbia University in collaboration with NIH, Teachers College, Beth Israel Deaconess Medical Center, and UChicago Medicine
What It’s Testing and Why It Matters
Following a strict gluten-free diet is challenging, and even harder to track accurately. This NIH-funded, multisite study is investigating whether combining telemedicine support with at-home gluten detection tools can help newly diagnosed celiac patients better manage their condition. Participants will be assigned to one of three groups: telemedicine only, gluten detection technology only, or both.
The study focuses on adults aged 18–75 who were diagnosed with celiac disease within the past four months. Over the course of one year, researchers will assess which approach most effectively supports gut healing (mucosal recovery) and improves overall quality of life.
Why It Stands Out
This trial goes beyond testing a new medication—it’s evaluating real-world digital and tech-enabled support systems. It addresses a critical challenge in celiac care: how to ensure long-term dietary adherence and wellness without overwhelming patients.
What It Could Mean for Patients
If proven effective, this approach could reshape standard care for celiac disease—empowering patients to monitor their gluten exposure from home, stay connected with dietitians, and take greater control of their health without added stress.
Location
The study is being conducted at several major academic centers in the United States. Active recruitment is currently underway at Beth Israel Deaconess Medical Center in Boston, Massachusetts, and Columbia University Irving Medical Center in New York, New York. Two additional sites—the University of Chicago Medical Center in Illinois and Vanderbilt University Medical Center in Tennessee are listed but are not yet recruiting.
See full study details and eligibility here.
5. A Phase 2 Trial Testing Fast-Tracked TEV-53408 to Prevent Gluten-Induced Gut Damage
Sponsor: Teva Branded Pharmaceutical Products R&D LLC
What It’s Testing and Why It Matters
This Phase 2 clinical trial is evaluating TEV-53408, a promising therapy aimed at preventing gluten-induced enteropathy—the intestinal damage that can occur in people with celiac disease, even from trace amounts of gluten. Rather than simply managing symptoms, this therapy is designed to block the immune response that leads to damage in the small intestine.
The study will monitor participants for up to 86 weeks to evaluate both safety and the therapy’s effectiveness during controlled gluten exposure. In May 2025, TEV-53408 received Fast Track designation from the U.S. FDA, highlighting its potential to address an urgent unmet need for patients who continue to suffer despite following a gluten-free diet.
Why It Stands Out
This is one of the few treatments under development that seeks to act as a protective buffer against accidental gluten exposure. Its Fast Track status signals both scientific promise and strong regulatory interest in accelerating access to meaningful treatment options.
What It Could Mean for Patients
If successful, TEV-53408 could greatly improve the quality of life for people with celiac disease by reducing their fear of hidden gluten and giving them more confidence and peace of mind when managing their diet.
Location
This trial is actively recruiting participants across the United States. Study sites are located in Colorado, Florida, Georgia, Michigan, North Carolina, Utah, and Virginia.
Take the Next Step Toward Better Celiac Care
Living with celiac disease shouldn’t mean living in fear of every bite. The clinical trials highlighted above are pushing boundaries—offering new possibilities to reduce symptoms, heal the gut, and even protect against accidental gluten exposure. If you’re looking for additional support, educational materials, or ways to connect with others living with celiac, trusted resources like the Celiac Disease Foundation, Beyond Celiac, National Celiac Association can help.
If you are a patient or caregiver, curious about other promising research in celiac disease, Visit TrialX.com to explore more studies or join our Volunteer Registry to receive updates on trials that match your health profile and location.
