Osteoarthritis of KneePhase 2NCT04506463
Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis
A Phase 2 study testing MM-II dose I, MM-II dose II and MM-II dose III in people with Osteoarthritis of Knee, run by Sun Pharmaceutical Industries Limited at 25 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- MM-II dose I, MM-II dose II and MM-II dose III
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 397 participants
- Where
- 25 sitesin 3 countries
- Study dates
- 22 Dec 2020to 10 Aug 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
25 sites in 3 countries.
25 sites in 3 countries
United States21 sites
Sunpharma site no. 20
Birmingham, Alabama, 35209
Sunpharma site no. 09
Charleston, South Carolina, 29406
SunPharma Site No 24
Columbia, South Carolina, 29206
Sunpharma site no. 19
Edmond, Oklahoma, 73013
Sunpharma site no. 18
Flossmoor, Illinois, 60422
Sunpharma site no. 21
Fort Mill, South Carolina, 29707
Sunpharma site no. 07
Hazelwood, Missouri, 63042
Sunpharma site no. 10
Lady Lake, Florida, 32159
Sunpharma site no. 08
Lake Worth, Florida, 33461
Sunpharma site no. 13
Maitland, Florida, 32751
Sunpharma site no. 22
Miami, Florida, 33145
Sunpharma Site no 27
Miami, Florida, 33155
Sunpharma site no. 12
Miami, Florida, 33155
SunPharma Site no 23
Miami, Florida, 33176
Sunpharma site no. 25
Riverside, California, 92503
Sunpharma site no. 26
San Diego, California, 92103
Sunpharma site no. 06
Stamford, Connecticut, 06905
Sunpharma site no. 05
Sunrise, Florida, 33351
Sunpharma site no. 11
Tempe, Arizona, 85283
Sunpharma site no. 04
The Villages, Florida, 32159
Sunpharma site no. 17
Williamsville, New York, 14221
Denmark3 sites
Sunpharma site no. 02
Gandrup, 9362
Sunpharma site no. 01
Herlev, 2730
Sunpharma site no. 03
Vejle, 7100
About this study
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
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
- Being tested
- MM-II dose I, MM-II dose II, MM-II dose III, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MM-II dose IDrug
Intra-articular injection
MM-II dose IIDrug
Intra-articular injection
MM-II dose IIIDrug
Intra-articular injection
PlaceboDrug
Intra-articular injection
PlaceboDrug
Intra-articular injection
PlaceboDrug
Intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | MM-II 1 ml Receives: Drug: MM-II dose I |
| Arm B | Experimental | MM-II 3 ml Receives: Drug: MM-II dose II |
| Arm C | Experimental | MM-II 6 ml Receives: Drug: MM-II dose III |
| Arm 4 | Placebo comparator | Placebo 1ml Receives: Drug: Placebo |
| Arm 5 | Placebo comparator | Placebo 3ml Receives: Drug: Placebo |
| Arm 6 | Placebo comparator | Placebo 6ml Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (2)
Change From Baseline in 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. Weekly post-baseline average daily knee pain scores will be calculated.
Measured: Week 26
Change From Baseline in Weekly Average of Daily Global Pain Scores by VAS
Global pain will be assessed on a score of 0 to 100; the lower on the scale, the less the amount of global pain experienced. Weekly post-baseline average daily global pain scores will be calculated
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start22 Dec 2020
- Primary completion4 May 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Moebius Medical Ltd., Nordic Bioscience Clinical Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506463
- Sponsor's protocol ID
- CLR_17_17
- Status last verified
- Jun 2024
- First submitted
- 6 Aug 2020
- Last updated
- 29 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04506463
- Acronym / sponsor ID
- CLR_17_17
- Conditions
- Osteoarthritis of Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Moebius Medical Ltd., Nordic Bioscience Clinical Development
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Posted 29 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: MM-II dose IMM-II 1 ml |
| Arm B | Experimental | Drug: MM-II dose IIMM-II 3 ml |
| Arm C | Experimental | Drug: MM-II dose IIIMM-II 6 ml |
| Arm 4 | Placebo comparator | Drug: PlaceboPlacebo 1ml |
| Arm 5 | Placebo comparator | Drug: PlaceboPlacebo 3ml |
| Arm 6 | Placebo comparator | Drug: PlaceboPlacebo 6ml |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MM-II dose IIntra-articular injection | Drug | Arm A |
| MM-II dose IIIntra-articular injection | Drug | Arm B |
| MM-II dose IIIIntra-articular injection | Drug | Arm C |
| PlaceboIntra-articular injection | Drug | Arm 4 |
| PlaceboIntra-articular injection | Drug | Arm 5 |
| PlaceboIntra-articular injection | Drug | Arm 6 |
Primary outcome
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.
2 secondary outcomes
Change From Baseline in Weekly Average of Daily Knee Pain Scores by VAS
Time frame: Week 26
Change From Baseline in Weekly Average of Daily Global Pain Scores by VAS
Time frame: Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MM-II dose I, MM-II dose II and MM-II dose III in people with Osteoarthritis of Knee, run by Sun Pharmaceutical Industries Limited at 25 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Denmark, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A Pain Score (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.