FB102 - (FB102-301)

October 8, 2026: argenx SE (Euronext, NASDAQ: ARGX) reported positive topline Phase 2 results for FB102, a first-in-class anti-CD122 antibody, in adults with celiac disease. In the randomized, double-blind, placebo-controlled FB102-301 study (NCT06982963), the trial met its primary endpoint: change from baseline in villus height-to-crypt depth ratio (Vh:Cd) at day 78 versus placebo during an eight-week gluten challenge (p=0.0176).

The company said FB102 showed a statistically significant and clinically relevant treatment effect versus placebo, with supportive findings across intraepithelial lymphocyte density, VCIEL composite score, and symptoms. Safety was consistent with prior studies and no new safety signals were identified.

The study enrolled 126 adults with confirmed celiac disease who had been symptom free on a strict gluten-free diet for at least 12 months; patients were randomized 2:2:1 to two FB102 dose levels or placebo, given by IV infusion.

argenx said these data support advancing FB102 into Phase 3 development. Detailed Phase 2 results are planned for presentation at an upcoming medical meeting. The release also notes FB102 has FDA Fast Track designation for celiac disease and is being evaluated in vitiligo and alopecia areata.