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

NCT04506463 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CLR_17_17
• Study Type: interventional
• Target: 397
• Locations: 3 countries
• Sites: 25

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.

Conditions

Osteoarthritis of Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (6)

Arm A

EXPERIMENTAL

MM-II 1 ml

Drug: MM-II dose I

Arm B

EXPERIMENTAL

MM-II 3 ml

Drug: MM-II dose II

Arm C

EXPERIMENTAL

MM-II 6 ml

Drug: MM-II dose III

Arm 4

PLACEBO COMPARATOR

Placebo 1ml

Drug: Placebo

Arm 5

PLACEBO COMPARATOR

Placebo 3ml

Drug: Placebo

Arm 6

PLACEBO COMPARATOR

Placebo 6ml

Drug: Placebo

Interventions

MM-II dose I DRUG

Intra-articular injection

Arm A

MM-II dose II DRUG

Intra-articular injection

Arm B

MM-II dose III DRUG

Intra-articular injection

Arm C

Placebo DRUG

Intra-articular injection

Arm 4

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead
• Moebius Medical Ltd.: collaborator
• Nordic Bioscience Clinical Development (NBCD): collaborator

Study Sites (25)

Sunpharma site no. 20

Birmingham, Alabama, 35209, United States

Location

Sunpharma site no. 11

Tempe, Arizona, 85283, United States

Location

Sunpharma site no. 25

Riverside, California, 92503, United States

Location

Sunpharma site no. 26

San Diego, California, 92103, United States

Location

Sunpharma site no. 06

Stamford, Connecticut, 06905, United States

Location

Sunpharma site no. 10

Lady Lake, Florida, 32159, United States

Location

Sunpharma site no. 08

Lake Worth, Florida, 33461, United States

Location

Sunpharma site no. 13

Maitland, Florida, 32751, United States

Location

Sunpharma site no. 22

Miami, Florida, 33145, United States

Location

Sunpharma Site no 27

Miami, Florida, 33155, United States

Location

Sunpharma site no. 12

Miami, Florida, 33155, United States

Location

SunPharma Site no 23

Miami, Florida, 33176, United States

Location

Sunpharma site no. 05

Sunrise, Florida, 33351, United States

Location

Sunpharma site no. 04

The Villages, Florida, 32159, United States

Location

Sunpharma site no. 18

Flossmoor, Illinois, 60422, United States

Location

Sunpharma site no. 07

Hazelwood, Missouri, 63042, United States

Location

Sunpharma site no. 17

Williamsville, New York, 14221, United States

Location

Sunpharma site no. 19

Edmond, Oklahoma, 73013, United States

Location

Sunpharma site no. 09

Charleston, South Carolina, 29406, United States

Location

SunPharma Site No 24

Columbia, South Carolina, 29206, United States

Location

Sunpharma site no. 21

Fort Mill, South Carolina, 29707, United States

Location

Sunpharma site no. 02

Gandrup, 9362, Denmark

Location

Sunpharma site no. 01

Herlev, 2730, Denmark

Location

Sunpharma site no. 03

Vejle, 7100, Denmark

Location

Sunpharma site no. 14

Hong Kong, 00000, Hong Kong

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Head-Clinical Development
• Organization: Sun Pharmaceutical Industries Limited

Clinical.Trial@sunpharma.com

2266455645

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 10, 2020
• Study Start: December 22, 2020
• Primary Completion: May 4, 2022
• Study Completion: August 10, 2022
• Last Updated: August 29, 2024
• Results First Posted: August 29, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3); HK (1); US (21)