The Flare | Briefing #011
Focus Sector: Autoimmune Research & Clinical Access
MISSION
The Flare audits unpublished, shelved, withdrawn, and terminated clinical trial data in the autoimmune and oncology sectors. We translate raw data into transparent briefings for patients, families, advocacy groups, and independent researchers.
EXECUTIVE SUMMARY
For 30 years, the only treatment for celiac disease has been a lifelong gluten-free diet. That is no longer the whole story. Three drugs are recruiting patients in active U.S. trials right now, and the furthest along, an antibody called FB102, just posted phase 1b results strong enough to move into a 100-person, 30-site phase 2 study. This briefing covers who is recruiting, what each drug is actually trying to do, and why this particular moment in celiac research looks different from the false starts that came before it.
THE EARLY SIGNAL INDEX (TRIAL 01 — THE FRONTRUNNER)
Study Name and ClinicalTrials.gov ID: FB102-301 (NCT06982963)
Sponsor: Forte Biosciences, Inc.
Location and Enrollment Criteria: Approximately 100 participants across up to 30 sites in the United States. Adults 18 to 70, biopsy-confirmed celiac disease and positive serology at least 12 months prior to screening, currently following a gluten-free diet.
The Mechanism of Action: FB102 is a monoclonal antibody designed to block the signaling of two cytokines, interleukin-2 and interleukin-15, that drive the immune system's attack on the small intestine when gluten is introduced.
Why It Matters
FB102 is not a new idea dressed up. It is a follow-on to a real result. In the phase 1b trial (FB102-101), 32 people on a gluten-free diet underwent a controlled 16-day gluten challenge. The group given FB102 showed a statistically significant improvement on the VCIEL endpoint, a composite measure of intestinal damage, compared to placebo (p=0.0099). Markers of active inflammation in the gut lining, including proliferating immune cells and cytotoxic T cells, were also significantly lower in the treated group. That is what earned FB102 a phase 2 trial, and it is why this one is worth watching rather than filing away.
THE EARLY SIGNAL INDEX (TRIAL 02 — THE TOLERANCE APPROACH)
Study Name and ClinicalTrials.gov ID: AVALON, VTP-1000 in Adults With Celiac Disease (NCT06310291)
Sponsor: Barinthus Biotherapeutics
Location and Enrollment Criteria: 16 sites across the United States. Adults 18 to 65 with biopsy-confirmed celiac disease within the past 10 years, on a gluten-free diet for at least 12 months, currently asymptomatic.
The Mechanism of Action: VTP-1000 is an injectable nanoparticle therapy that delivers gluten-derived peptides alongside rapamycin, an immune-modulating compound, in an attempt to retrain the immune system to tolerate gluten rather than simply blunting the reaction after the fact.
Why It Matters
Every other trial in this briefing is trying to suppress the immune response once gluten is already in the picture. VTP-1000 is trying something structurally different: teaching the immune system not to treat gluten as a threat in the first place. The single ascending dose portion of AVALON reported no treatment-related serious adverse events across three dose cohorts, with a dose-dependent immune response observed. The multiple ascending dose portion, which includes its own controlled gluten challenge, is enrolling now, with data expected in the second half of 2026.
PIPELINE WATCH
Beyond the two lead programs, the celiac pipeline has more activity in it right now than at any point in recent memory, with several crucial data readouts concentrated between late 2026 and mid-2027.
Amlitelimab (NCT06557772), sponsored by Sanofi, is a phase 2a/b trial testing a subcutaneous antibody in patients whose celiac disease has not responded to a gluten-free diet alone. The trial has completed enrollment, with initial data expected around mid-to-late 2027.
DONQ52, the DAISY study (NCT07239336), sponsored by Chugai Pharmaceutical, is a phase 2 trial for patients with confirmed duodenal damage and ongoing symptoms despite strict dietary adherence. It is currently recruiting.
ANB033, developed by First Tracks Biotherapeutics (spun off from AnaptysBio in April 2026), is a CD122 antagonist in an active global phase 1b trial. The study features an innovative two-cohort design: one cohort undergoes a controlled gluten challenge to evaluate whether the therapy prevents acute mucosal damage, while the second cohort enrolls patients with existing intestinal damage to see if it can actively accelerate gut healing. Top-line data from this program is anticipated in Q4 2026.
The throughline across all five programs: for the first time, celiac disease is being treated less like a diet problem and more like the systemic autoimmune disease it is.
Looking for options? To find clinical trials for any condition, anywhere in the world, use the tracking tool hosted by our partners at mytrials.ai/t/the-flare.
THE CLINICAL INTELLIGENCE BRIEF (DID YOU KNOW?)
Several of these trials use something called the VCIEL endpoint. It stands for Villus Crypt Intraepithelial Lymphocytes, and together the two numbers are the closest thing celiac research has to a single scorecard for gut damage. Villi are the small, finger-like projections lining the intestine that absorb nutrients; in celiac disease, gluten exposure flattens them and increases crypt depth, while intraepithelial lymphocytes, a type of immune cell embedded in the intestinal lining, spike in number. A drug that improves VCIEL is a drug that is measurably protecting the gut, not just easing symptoms.
THE VISUAL DRUG PIPELINE
Five programs, three phases. VTP-1000 sits earliest at phase 1, ANB033 is in phase 1b, and FB102, amlitelimab, and DONQ52 have all advanced into phase 2. No program has yet reached phase 3.
SOURCES & DATA AUDITS
LEGAL DISCLAIMER
Disclaimer: The Flare is an independent investigative journalism outlet. We are not medical providers, clinical trial sites, or financial advisors. This information is for educational and journalistic purposes only and does not constitute medical advice.
