XBiotech Launches Phase II Clinical Trial Evaluating Vilamakitug for the Treatment of Active Axial Spondyloarthritis
XBiotech announced that the FDA completed its 30-day review of the IND application for the V-SPINE study without placing a clinical hold, clearing the path for U.S. patient enrollment. The Phase II, double-blind, placebo-controlled trial will evaluate 400 mg of vilamakitug administered via 16 weekly subcutaneous injections in 150 adult participants with active axial spondyloarthritis. The primary endpoint is the proportion of participants achieving an ASAS40 response at Week 16, with a 12-week open-label extension planned for all participants.
Key figures
- Drug Name
- vilamakitug
- Phase Of Trial
- Phase II
- Dosage
- 400 mg
- Study name
- V-SPINE (PT064)
- Administration
- 16 weekly subcutaneous injections
- Primary endpoint
- ASAS40 response at Week 16
- Participant count
- 150
- Prior asset sale value
- $1.35 billion
AI analysis
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