A phase 2b double-blind placebo-controlled randomized clinical trial of SB-061, an aggrecan mimetic, in patients with symptomatic knee osteoarthritis
Authors' conclusion
Intra-articular injections of SB-061 administered at baseline, Week 16, and Week 32, over one year in subjects with knee OA, were safe but did not show any statistically significant effect on knee pain nor on other symptomatic or structural entities compared to placebo.
Study context
- Population
- Subjects with knee osteoarthritis (OA), KL grade 2 or 3 on X-ray of the target knee and WOMAC pain score ≥20 out of 50; other knee conditions excluded252 (87.5%) completed injections
- Participants
- 288 subjects
- Comparison
- Intra-articular SB-061 vs placebo (isotonic saline) at baseline, Wk 16 and Wk 32 for 52 weeks
- SB-061n = 145
- Placebon = 143reference
- Primary endpoint
- Change from baseline in WOMAC pain
- Follow-up
- Week 8
Methodological detailsphase II, double-blind, placebo-controlled
- Phase II
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
- Primary endpoint not met: no significant difference between groups at Week 8, nor at any other time point
Secondary outcomes
Secondary (WOMAC function and total, ICOAP, PGA, 20-meter walk test) and exploratory (structural MRI) endpoints
- No significant difference between groups
Original publication
A phase 2b double-blind placebo-controlled randomized clinical trial of SB-061, an aggrecan mimetic, in patients with symptomatic knee osteoarthritis. Osteoarthritis Cartilage. Published 1 July 2024. doi:10.
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