Galapagos Reports Initiation of P-III Trial (OLINGUITO) for Filgotinib to Treat Active Axial Spondyloarthritis
Shots:
- The first patient has been randomized in the P-III trial (OLINGUITO) evaluating filgotinib (200mg, qd) vs PBO in a ratio (1:1) in 476 patients with active r-AxSpA (study A) & nrAxSpA (study B). Patients will be re-randomized at 52wk. & received filgotinib (100/200mg for ~ 104wk.) who achieved sustained low disease activity in the open-label treatment period
- The 1EPs for studies A & B is the proportion of patients who achieve an ASAS403 response at 12wk. in compliance with the EMA’s guidelines & the results are expected in H2’25. The studies will be followed by an OLE period
- The P-II study (TORTUGA) results of filgotinib (JAK1 preferential inhibitor) showed a greater improvement in ASDAS @12wk. with encouraging safety profiles in patients with active r-AxSpA
Ref: Globe Newswire | Image: Galapagos
Related News:- Galapagos Reports P-III Trial (DIVERSITY) Results of Filgotinib for the Treatment of Crohn’s Disease
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