Trial | NCT04506463  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    397
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 Started
Dec 22
2020
Primary Completion
May 04
2022
Study Completion
Aug 10
2022
Last Update
Apr 03
2023

Drug MM-II dose I

Intra-articular injection

Drug MM-II dose II

Intra-articular injection

Drug MM-II dose III

Intra-articular injection

Drug Placebo

Intra-articular injection

Drug Placebo

Intra-articular injection

Drug Placebo

Intra-articular injection

Arm A Experimental

MM-II 1 ml

Arm B Experimental

MM-II 3 ml

Arm C Experimental

MM-II 6 ml

Arm 4 Placebo Comparator

Placebo 1ml

Arm 5 Placebo Comparator

Placebo 3ml

Arm 6 Placebo Comparator

Placebo 6ml

Criteria 

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
No Results Posted