A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis

Phase 3 Active not recruiting 495 enrolled Alfasigma S.p.A.

RandomizedParallel-groupTriple-blindTreatment

Summary

This study is comparing 200 milligrams (mg) of filgotinib a day with a placebo to see if filgotinib helps to treat Axial Spondyloarthritis (axSpA) and is safe to use. The study will also be comparing 200 mg with 100 mg filgotinib a day to see if the lower dose also helps to treat axSpA.

Timeline

Start: 2023-04-05
Primary completion: 2024-09-04
Completion: 2028-12

Outcome

Met primary endpoint

release “Filgotinib, an oral, once-daily JAK1 preferential inhibitor, met the primary endpoint in the OLINGUITO Phase 3 clinical trial in active axSpA.” alfasigma.com ↗

Publications

Zhang X, Jia L, Lin X, Zhou L. Exhaustion-Resistant CD8 + T Cells in Ankylosing Spondylitis: A Proposed Three-Axis Model. Immunology. 2025 Dec;176(4):409-420. doi: 10.1111/imm.70044. Epub 2025 Oct 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Filgotinib	Small molecule	100 mg	Oral
Subject	Filgotinib	Small molecule	200 mg	Oral