Intra-articular MM-II for the treatment of knee osteoarthritis pain: Efficacy and safety results from a 26-week, phase 2b, placebo-controlled, double-blind, randomized dose-ranging trial
Primary result · Change in WOMAC pain (0-4)Result — go to the resultLeast squares mean difference −0.24 95% CI −0.48 to 0.00Authors' conclusion
MM-II was safe, and the optimal effective dose for the treatment of knee OA pain was 3 mL.
Study context
- Population
- Age ≥40 years with radiographic and symptomatic knee osteoarthritis (OA) painreceived treatment
- Participants
- 396 participants
- Comparison
- Single intra-articular injection of 1, 3 or 6 mL MM-II vs 1, 3 or 6 mL placebo
- Primary endpoint
- Change from baseline in WOMAC pain (range 0-4), multiplicity-adjusted
- Follow-up
- 12 weeks post-injection
Methodological detailsphase 2b, double-blind, placebo-controlled, dose-ranging
- Phase 2b
- Double-blind
- Placebo-controlled
- Dose-ranging
Primary result
Change in WOMAC pain (0-4) · week 12
Least squares mean difference
−0.24
95% CI −0.48 to 0.00
multiplicity-adjusted P = 0.085
3 mL MM-IIvs Placebo
least squares mean difference −0.24 (95% CI −0.48 to 0.00); multiplicity-adjusted P = 0.085
As reported in the abstract
Secondary outcomes
Weekly average of daily knee pain (WADP), 3 mL MM-II vs placebo · week 12
- WADP improvement in the 3 mL group at week 12
- −10.9 [−18.9, −2.8]
- Unadjusted P <0.01
Weekly average of daily knee pain (WADP), 3 mL MM-II vs placebo · week 26
- WADP improvement in the 3 mL group lasting through week 26
- −11.8 [−20.4, −3.3]
- Unadjusted P <0.01
WOMAC function and patient global assessment (PtGA)
- Numeric improvements in WOMAC function from week 8-26, and PtGA at weeks 16 and 26
Rescue medication use
- Rescue medication use with 3 mL MM-II consistent with reduced pain
Dose comparison
- Results numerically superior with 3 mL MM-II vs 1 mL MM-II; 6 mL MM-II the least efficacious dose
Safety
- MM-II well tolerated, with low TEAE incidence
Original publication
Intra-articular MM-II for the treatment of knee osteoarthritis pain: Efficacy and safety results from a 26-week, phase 2b, placebo-controlled, double-blind, randomized dose-ranging trial. Osteoarthritis Cartilage. Published 23 April 2025. doi:10.
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