NCT04506463CompletedPhase 2
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Single-administration, Multiple-Dose Study to Demonstrate the Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis
Sun Pharmaceutical Industries Limited25 sites in 3 countries397 target enrollmentStarted: December 22, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 397
- Locations
- 25
- Primary Endpoint
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A Pain Score
Study Overview
Brief Summary
This is a phase IIb, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of MM-II in subjects with symptomatic knee OA as compared to matching placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is able to provide written consent, understand study requirements, is prepared to complete study procedures and is able to independently communicate meaningfully with study personnel
- •Presence of index knee pain for at least 6 months prior to Screening
- •Men or women ≥ 40 years of age at the time of Screening
- •Radiographic evidence of knee Osteoarthritis
Exclusion Criteria
- •Pain in the contralateral knee with a severity of ≥ 30 mm on a 100 mm VAS
- •Presence of ≥ 40 mm on a 100 mm VAS pain in any other joints
- •Concomitant moderate or large size synovial fluid effusion of the index knee at Screening .
- •Known diagnosis of infection in the index knee in the past five years prior to Screening
Arms & Interventions
Arm A
Experimental
MM-II 1 ml
Intervention: MM-II dose I (Drug)
Arm B
Experimental
MM-II 3 ml
Intervention: MM-II dose II (Drug)
Arm C
Experimental
MM-II 6 ml
Intervention: MM-II dose III (Drug)
Arm 4
Placebo Comparator
Placebo 1ml
Intervention: Placebo (Drug)
Arm 5
Placebo Comparator
Placebo 3ml
Intervention: Placebo (Drug)
Arm 6
Placebo Comparator
Placebo 6ml
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A Pain Score
Time Frame: Week 12
The pain score is based on a score of 0 to 4; the higher the score, the higher the amount of pain.
Secondary Outcomes
- Change From Baseline in Weekly Average of Daily Knee Pain Scores by VAS(Week 26)
- Change From Baseline in Weekly Average of Daily Global Pain Scores by VAS(Week 26)
Investigators
Study Sites (25)
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Related News
FDA Grants Fast Track Designation to MM-II for Osteoarthritis Knee Pain- The FDA has granted Fast Track designation to MM-II, a non-opioid liposomal suspension, for treating osteoarthritis (OA) knee pain, potentially expediting its development and review.
- Phase 2b trial data showed a single intra-articular injection of MM-II provided significant pain relief compared to placebo for up to 26 weeks in OA patients.
- The Fast Track designation highlights the potential of MM-II to address the unmet need for effective and durable treatments for osteoarthritis, a prevalent degenerative joint disease.
- MM-II demonstrated a greater than 50% improvement in knee pain from weeks 12 to 26, supporting its potential for accelerated regulatory approval.last yearSun Pharma and Moebius Medical's MM-II Receives FDA Fast Track Designation for Osteoarthritis Knee Pain- The FDA granted Fast Track Designation to MM-II for osteoarthritis knee pain, expediting its development and review process.
- MM-II is a non-opioid product using liposomes to reduce joint friction, offering a novel approach to pain relief.
- Phase 2b data showed a single MM-II injection provided greater pain relief than placebo for up to 26 weeks.
- Sun Pharma and Moebius Medical are advancing MM-II to Phase 3 trials and seeking CE Mark for EU market entry.2 years ago