By Lew Kizer — 2026-10-17 — Health & Nutrition
The short answer
On October 8, 2026, argenx reported that FB102, an investigational anti-CD122 antibody, met the primary endpoint of a 126-patient Phase 2 celiac trial (p=0.0176), measured by gut-lining structure during an eight-week gluten challenge. Results are company topline data, not yet peer-reviewed. argenx plans Phase 3. No celiac drug is FDA-approved, so a strict gluten-free diet remains the only treatment.
Key facts
- Trial FB102-301 randomized 126 adults with celiac disease 2:2:1 to two IV doses of FB102 or placebo.
- All participants had been symptom-free on a strict gluten-free diet for at least 12 months.
- Primary endpoint: change in villus height-to-crypt depth ratio at day 78 during an eight-week gluten challenge.
- argenx reported the endpoint was met (p=0.0176) with no new safety signals; effect sizes were not disclosed.
- argenx acquired FB102 through its purchase of Forte Biosciences, completed in August 2026.
- Separately, the Celiac Disease Foundation launched the Inside Celiac podcast on October 15, 2026.
KINGSPORT, Tenn., Oct. 17, 2026 — For about 30 years, the only treatment for celiac disease has been the gluten-free diet. A trial result announced this month is one of the clearest signs yet that a medicine could one day sit alongside it.
On October 8, Amsterdam-based argenx said its antibody FB102 met the primary endpoint of a Phase 2 study in adults with celiac disease. The company plans to move the drug into Phase 3.
This article reports research news and is not medical advice.
What the trial tested
The study, called FB102-301, enrolled 126 adults with confirmed celiac disease who had been symptom-free on a strict gluten-free diet for at least a year. Participants were randomized to one of two intravenous doses of FB102 or a placebo, then asked to eat gluten for eight weeks under supervision.
The main measure was the villus height-to-crypt depth ratio at day 78, a biopsy-based look at whether the finger-like lining of the small intestine stayed intact. argenx reported a statistically significant difference versus placebo (p=0.0176). Immune-cell counts in the gut lining, a combined score and symptoms moved in the same direction, and no new safety signals appeared.
argenx did not publish effect sizes. Full results are expected at a medical meeting, and the data have not yet been peer-reviewed.
“These positive Phase 2 results strengthen our conviction in the potential of FB102.” — Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx
Where FB102 fits in the celiac pipeline
FB102 blocks CD122, a receptor that helps pass inflammatory signals (from IL-2 and IL-15) to immune cells involved in celiac damage. argenx acquired the drug when it bought Forte Biosciences, a deal completed in August 2026.
It is one of several candidates in development. Others take different approaches, from teaching the immune system to tolerate gluten to blocking other immune pathways. Most remain in early or mid-stage trials, and The Flare's 2026 pipeline review noted that no program had reached Phase 3 before this announcement.
A new resource for the celiac community
One week later, on October 15, the Celiac Disease Foundation launched Inside Celiac, a monthly podcast hosted by actress Katie Lowes, who has celiac disease. New episodes are planned for the third Thursday of each month and will cover diagnosis, daily life, research and clinical trials. CEO Marilyn G. Geller called it “a significant new chapter” in the foundation's education work.
What it means at the dinner table this week
Nothing changes yet. Even the participants in this trial had to maintain a strict gluten-free diet to qualify. If you were recently diagnosed, our newly diagnosed celiac meal guide walks through the first weeks.
“The average person with celiac disease waits six years for a diagnosis. We exist for those people.” — Lew Kizer, Founder, SmashMeals
See how our dedicated gluten-free kitchen works and what our gluten-free standards do and do not cover. Then browse this week's meals.
Commentary, not medical advice
The SmashMeals perspective
For the people we cook for, this is hopeful news, and it is still years from a pharmacy shelf. Even the trial participants had to be strict on a gluten-free diet before they could enroll. That is the daily reality we built our kitchen around: SmashMeals operates a dedicated gluten-free kitchen, so customers are not choosing from one gluten-free line beside a regular wheat line. Gluten is not the only allergen, so check each meal's ingredients and ask us anything before you order.
Frequently asked questions
Is FB102 approved to treat celiac disease?
No. FB102 is investigational. argenx reported positive Phase 2 topline results on October 8, 2026 and plans Phase 3 trials. No drug is FDA-approved for celiac disease.
Will a celiac drug mean I can eat gluten again?
Nobody knows yet. Candidates like FB102 are being tested to protect the gut during gluten exposure, not to replace the diet. Until a drug is approved and your doctor advises otherwise, a strict gluten-free diet remains the treatment.
What did the FB102 trial measure?
The main measure was the ratio of villus height to crypt depth in the small intestine, a sign of gut-lining damage, after an eight-week gluten challenge. The company also reported supportive results on immune-cell counts and symptoms.
Sources and credits
Follow the original sources for context and verification. A reference is not an endorsement of SmashMeals.
- argenx announces positive topline results from Phase 2 study of FB102 in celiac disease (opens in a new tab)
argenx
Why it matters: Primary source for the trial design, endpoint and next steps.
- argenx completes Forte Biosciences acquisition (opens in a new tab)
ChemXplore
Why it matters: Explains how FB102 moved from Forte to argenx.
- The celiac pipeline is finally moving past symptom management (opens in a new tab)
The Flare
Why it matters: Independent overview of other celiac candidates in 2026.
- Celiac Disease Foundation announces Inside Celiac podcast (opens in a new tab)
Celiac Disease Foundation via PR Newswire
Why it matters: A new free education resource for the celiac community.