AMSTERDAM, the Netherlands — October 8, 2026

argenx SE (Euronext & Nasdaq: ARGX), a global immunology innovation company, announced positive topline results from its Phase 2 study of FB102, an investigational, first-in-class CD122 inhibitor, in adults with celiac disease. The study met its primary endpoint, demonstrating a statistically significant difference versus placebo in the change from baseline in the villus height-to-crypt depth (Vh) ratio at Day 78 following a controlled gluten challenge (p=0.0176). The findings indicate that FB102 may help protect the intestinal lining from gluten-induced damage, addressing a key unmet need in a condition with no currently approved drug treatments.

Findings Support Protection Against Gluten-Induced Damage

The Phase 2 study also reported consistent trends across additional efficacy measures, including intraepithelial lymphocyte (IEL) density, the Vh–IEL composite score and patient symptoms. Together, these findings provide supporting evidence across intestinal tissue changes, inflammation and clinical symptoms. The randomized, double-blind, placebo-controlled study enrolled 126 adults with confirmed celiac disease who had followed a strict gluten-free diet for at least 12 months. Participants received one of two intravenous FB102 dose levels or placebo while undergoing an eight-week oral gluten challenge. Detailed results are expected to be presented at an upcoming medical meeting.

FB102 Shows Consistent Safety Profile

According to argenx, the safety profile observed in the Phase 2 study was consistent with previous studies, with no new safety signals identified. FB102 is an investigational anti-CD122 antibody designed to modulate interleukin-2 (IL-2) and interleukin-15 (IL-15) signaling pathways involved in disease-driving immune cells while preserving regulatory T-cell function. The U.S. Food and Drug Administration has granted FB102 Fast Track Designation for celiac disease. The company said the Phase 2 findings build on earlier Phase 1b evidence supporting CD122 blockade as a potential approach to preventing gluten-related intestinal injury.

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argenx Plans Phase 3 Development

argenx plans to advance FB102 into Phase 3 development for celiac disease following the positive topline results. The company is also evaluating FB102 in other autoimmune conditions, including vitiligo and alopecia areata. Celiac disease is a chronic autoimmune disorder triggered by gluten, which can damage the small intestine and impair nutrient absorption. A strict gluten-free diet remains the standard of care, and the lack of approved medicines highlights the need for additional treatment options. The planned Phase 3 program will further evaluate FB102’s potential to protect intestinal tissue and improve outcomes for people living with celiac disease.

Source::argenx, press release