Evaluation of S201086/GLPG1972, an ADAMTS-5 inhibitor, for the treatment of knee osteoarthritis in ROCCELLA: a phase 2 randomized clinical trial
Authors' conclusion
Despite enrolment of participants who experienced substantial cartilage loss over 52 weeks, during the same time period, S201086/GLPG1972 did not significantly reduce rates of cartilage loss or modify symptoms in adults with symptomatic knee osteoarthritis.
Study context
- Population
- Adults (aged 40–75 years) with knee OA, moderate-to-severe pain in the target knee, Kellgren-Lawrence grade 2 or 3 and OARSI joint space narrowing (grade 1 or 2)enrolled
- Participants
- 932 adults
- Comparison
- Once-daily oral S201086/GLPG1972 75, 150 or 300 mg vs placebo for 52 weeks
- Primary endpoint
- Change from baseline in central medial femorotibial compartment (cMFTC) cartilage thickness by quantitative MRI
- Follow-up
- Week 52
Methodological detailsdouble-blind, placebo-controlled, dose-ranging, phase 2
- Double-blind
- Placebo-controlled
- Dose-ranging
- Phase 2
Primary result
As reported in the abstract
cMFTC cartilage loss
- No significant differences in central medial femorotibial compartment (cMFTC) cartilage loss between placebo and S201086/GLPG1972 groups
- 75 mg vs Placebo: P = 0.165
- 150 mg vs Placebo: P = 0.939
- 300 mg vs Placebo: P = 0.682
Secondary outcomes
Secondary endpoints (radiographic joint space width, WOMAC total and subscores, pain VAS) · week 52
- No significant differences in any secondary endpoint between placebo and treatment groups
Original publication
Evaluation of S201086/GLPG1972, an ADAMTS-5 inhibitor, for the treatment of knee osteoarthritis in ROCCELLA: a phase 2 randomized clinical trial. Osteoarthritis Cartilage. Published 13 April 2023. doi:10.
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