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

Osteoarthritis of Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04506463
• Other study ID #: CLR_17_17
• Status: Completed
• Phase: Phase 2
• Start date: December 22, 2020
• Est. completion date: August 10, 2022

Study information

• Verified date: June 2022
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: August 10, 2022
• Est. primary completion date: May 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 99 Years

Eligibility

Inclusion Criteria:

1. 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

2. Presence of index knee pain for at least 6 months prior to Screening

3. Men or women = 40 years of age at the time of Screening

4. Radiographic evidence of knee Osteoarthritis

Exclusion Criteria:

1. Pain in the contralateral knee with a severity of = 30 mm on a 100 mm VAS

2. Presence of = 40 mm on a 100 mm VAS pain in any other joints

3. Concomitant moderate or large size synovial fluid effusion of the index knee at Screening .

4. Known diagnosis of infection in the index knee in the past five years prior to Screening

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of Knee
• Osteoarthritis, Knee

Intervention

Drug:
• MM-II dose I
Intra-articular injection
• MM-II dose II
Intra-articular injection
• MM-II dose III
Intra-articular injection
• Placebo
Intra-articular injection
• Placebo
Intra-articular injection
• Placebo
Intra-articular injection

Locations

Country	Name	City	State
Denmark	Sunpharma site no. 02	Gandrup
Denmark	Sunpharma site no. 01	Herlev
Denmark	Sunpharma site no. 03	Vejle
Hong Kong	Sunpharma site no. 14	Hong kong
United States	Sunpharma site no. 20	Birmingham	Alabama
United States	Sunpharma site no. 09	Charleston	South Carolina
United States	SunPharma Site No 24	Columbia	South Carolina
United States	Sunpharma site no. 19	Edmond	Oklahoma
United States	Sunpharma site no. 18	Flossmoor	Illinois
United States	Sunpharma site no. 21	Fort Mill	South Carolina
United States	Sunpharma site no. 07	Hazelwood	Missouri
United States	Sunpharma site no. 10	Lady Lake	Florida
United States	Sunpharma site no. 08	Lake Worth	Florida
United States	Sunpharma site no. 13	Maitland	Florida
United States	SunPharma Site no 23	Miami	Florida
United States	Sunpharma Site no 27	Miami	Florida
United States	Sunpharma site no. 12	Miami	Florida
United States	Sunpharma site no. 22	Miami	Florida
United States	Sunpharma site no. 25	Riverside	California
United States	Sunpharma site no. 26	San Diego	California
United States	Sunpharma site no. 06	Stamford	Connecticut
United States	Sunpharma site no. 05	Sunrise	Florida
United States	Sunpharma site no. 11	Tempe	Arizona
United States	Sunpharma site no. 04	The Villages	Florida
United States	Sunpharma site no. 17	Williamsville	New York

Sponsors (3)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited	Moebius Medical Ltd., Nordic Bioscience Clinical Development (NBCD)

Countries where clinical trial is conducted

United States,  Denmark,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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