Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteoarthritis of Knee

Intervention / Treatment
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* Drug: MM-II dose I
* Drug: MM-II dose II
* Drug: MM-II dose III
* Drug: Placebo
* Drug: Placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>MM-II 1 ml | Drug: MM-II dose I<br>* Intra-articular injection<br>|
| Experimental: Arm B<br>MM-II 3 ml | Drug: MM-II dose II<br>* Intra-articular injection<br>|
| Experimental: Arm C<br>MM-II 6 ml | Drug: MM-II dose III<br>* Intra-articular injection<br>|
| Placebo Comparator: Arm 4<br>Placebo 1ml | Drug: Placebo<br>* Intra-articular injection<br>|
| Placebo Comparator: Arm 5<br>Placebo 3ml | Drug: Placebo<br>* Intra-articular injection<br>|
| Placebo Comparator: Arm 6<br>Placebo 6ml | Drug: Placebo<br>* Intra-articular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Western Ontario and McMaster Universities osteoarthritis index (WOMAC) A pain score | The pain score is based on a score of 0 to 4; the higher the score, the higher the amount of pain. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly average of daily knee pain scores by VAS | Knee pain will be assessed on a score of 0 to 100; the lower on the scale, the less the amount of knee pain experienced. | Week 26 | 
| Weekly average of daily global pain scores by VAS | Knee pain will be assessed on a score of 0 to 100; the lower on the scale, the less the amount of knee pain experienced. | Week 26 |