Schnitzer, T.J. orcid.org/0000-0002-4048-5431, Chevalier, X., Rovsing, H. et al. (11 more authors) (2025) 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 and Cartilage, 33 (7). pp. 897-906. ISSN 1063-4584
Abstract
Objective
Determine optimal dose, efficacy, and safety of MM-II, a suspension of large empty liposomes, for knee osteoarthritis (OA) pain.
Method
A double-blind phase 2b study (NCT04506463) randomized participants 3:3:3:1:3:1 to one intra-articular injection of 1, 3, or 6 mL MM-II or 1, 3, or 6 mL placebo, respectively. Inclusion criteria included age ≥40 years and radiographic and symptomatic knee OA. The primary endpoint was change from baseline in Western Ontario and McMaster Universities OA Index (WOMAC) pain (range, 0–4) 12 weeks post-injection (multiplicity-adjusted). Secondary endpoints included weekly average of daily knee pain (WADP), WOMAC pain at other visits, WOMAC function, patient global assessment (PtGA), and rescue medication use. Safety was assessed by treatment-emergent adverse events (TEAEs).
Results
Overall, 396 participants received treatment. In the 3 mL MM-II vs placebo group, WOMAC pain numerically improved at week 12 (least squares mean difference [95% confidence interval], −0.24 [−0.48, 0.00]; unadjusted P=0.047; multiplicity-adjusted P=0.085 [primary endpoint not met]). In the same 3 mL group, WADP showed improvements at week 12 (−10.9 [−18.9, −2.8]) lasting through week 26 (−11.8 [−20.4, −3.3]; unadjusted P<0.01 at both time points). Numeric improvements were also seen in WOMAC function from week 8–26, and PtGA at weeks 16 and 26. Rescue medication use with 3 mL MM-II was consistent with reduced pain. Results were numerically superior with 3 mL MM-II vs 1 mL MM-II; 6 mL MM-II was the least efficacious dose. MM-II was well-tolerated, with low TEAE incidence.
Conclusion
MM-II was safe, and the optimal effective dose for the treatment of knee OA pain was 3 mL.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2025 The Author(s). Published by Elsevier Ltd on behalf of Osteoarthritis Research Society International. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/). |
Keywords: | MM-II, Liposome, Knee, Osteoarthritis, Phase 2, Clinical trial, Pain |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 28 Apr 2025 11:10 |
Last Modified: | 12 Jun 2025 14:31 |
Published Version: | https://www.sciencedirect.com/science/article/pii/... |
Status: | Published |
Publisher: | Elsevier |
Identification Number: | 10.1016/j.joca.2025.04.006 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:225809 |
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