OsteoarthritisPhase 1/2MODIFY-OANCT02802709
A Trial of SB-061 in Osteoarthritis of the Knee
A Phase 1/2 study testing SB-061 in people with Osteoarthritis, run by Symic OA Co. at 2 sites in Estonia.
Trial summary
This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee. Half of the patients will receive the agent via intra-articular injection and half will receive a placebo injection. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- SB-061
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesEstonia
- Study dates
- May 2016to Jun 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Femorotibial osteoarthritis of the knee
- Radiological OA Kellgren-Lawrence grade 2 or 3
- WOMAC Pain 1 score of the target knee of ≥4 and ≤ 9
Who cannot join
- Hypersensitivity to medications or to intra-articular injections
- Intra-articular delivery of corticosteroids or hyaluronic acid in the target knee within 6 months of study
- High dose systemic corticosteroid treatment of longer (>14 days) duration w/in 6 months of study
- Major surgery or arthroscopy of the target knee within year prior to study
- Planned surgery in the target knee within the next 3 months
- Concomitant inflammatory disease affecting either knee
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Placebo-controlled, Double-blind, Randomized Trial of an Intra-articular Device, SB-061, in Symptomatic Osteoarthritis of the Knee
This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee. Half of the patients will receive the agent via intra-articular injection and half will receive a placebo injection.
Read the detailed description
The treatment of pain associated with osteoarthritis may include periodic intra-articular injections of corticosteroids or viscosupplements such as hyaluronic acid. SB-061 is anticipated to relieve osteoarthritis pain by reinforcing the cartilage matrix and providing a lubricating coating of the cartilage. Subjects will receive 2 intra-articular injections of either SB-061 or placebo and be followed for 3 months to evaluate pain amelioration. Subjects and Investigators are blinded to treatment allocation.
- Conditions
- Osteoarthritis
- Being tested
- SB-061, Placebo
- Keywords
- knee
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-061Device
delivered via intra-articular injection
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SB-061 | Experimental | SB-061 Receives: Device: SB-061 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain (A1) scores from baseline to 3 months post treatment will be compared between treatment and control groups.
Measured: Baseline, 3 months
Incidence of Treatment-Emergent Adverse Events
A summary of Treatment-Emergent Adverse Events will be reported
Measured: Through 3 months
Secondary outcomes (3)
Pain
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) sub-scores scores related to pain from baseline to 3 months post treatment will be compared between treatment and control groups.
Measured: Baseline, 3 months
Physical function
Change in Patient Global Assessement scores from baseline to 3 months post treatment will be compared between treatment and control groups.
Measured: Baseline, 3 months
Pain
Change in Numeric Rating Scale (NRS) of pain from baseline to 3 months post treatment will be compared between treatment and control groups.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionFeb 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Symic OA Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nordic Bioscience Clinical Development
- Responsible party
- Sponsor
- Investigators
- Nathan Bachtell, MD, Study director, Symic OA Co.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802709
- Sponsor's protocol ID
- TP-1621
- Acronym
- MODIFY-OA
- Status last verified
- Jan 2018
- First submitted
- 27 May 2016
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Double-blind, Randomized Trial of an Intra-articular Device, SB-061, in Symptomatic Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02802709
- Acronym / sponsor ID
- MODIFY-OA / TP-1621
- Conditions
- Osteoarthritis
- Keywords
- knee
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Symic OA Co.Industry (pharma, biotech, devices)
- Collaborators
- Nordic Bioscience Clinical Development
- Study start
- May 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee. Half of the patients will receive the agent via intra-articular injection and half will receive a placebo injection.
Detailed description
The treatment of pain associated with osteoarthritis may include periodic intra-articular injections of corticosteroids or viscosupplements such as hyaluronic acid. SB-061 is anticipated to relieve osteoarthritis pain by reinforcing the cartilage matrix and providing a lubricating coating of the cartilage. Subjects will receive 2 intra-articular injections of either SB-061 or placebo and be followed for 3 months to evaluate pain amelioration. Subjects and Investigators are blinded to treatment allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SB-061 | Experimental | Device: SB-061SB-061 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Femorotibial osteoarthritis of the knee
- Radiological OA Kellgren-Lawrence grade 2 or 3
- WOMAC Pain 1 score of the target knee of ≥4 and ≤ 9
Key exclusion criteria (6 listed)
- Hypersensitivity to medications or to intra-articular injections
- Intra-articular delivery of corticosteroids or hyaluronic acid in the target knee within 6 months of study
- High dose systemic corticosteroid treatment of longer (>14 days) duration w/in 6 months of study
- Major surgery or arthroscopy of the target knee within year prior to study
- Planned surgery in the target knee within the next 3 months
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 |
|---|---|---|
| SB-061delivered via intra-articular injection | Device | SB-061 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Pain
Time frame: Baseline, 3 months
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain (A1) scores from baseline to 3 months post treatment will be compared between treatment and control groups.
Incidence of Treatment-Emergent Adverse Events
Time frame: Through 3 months
A summary of Treatment-Emergent Adverse Events will be reported
3 secondary outcomes
Pain
Time frame: Baseline, 3 months
Physical function
Time frame: Baseline, 3 months
Pain
Time frame: Baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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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.
Nathan Bachtell, MD study director
Symic OA Co.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SB-061 in people with Osteoarthritis, run by Symic OA Co. at 2 sites in Estonia.
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 3 inclusion and 6 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 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Estonia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain (time frame: Baseline, 3 months). The study lists 2 primary outcomes in all. 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 4 Jan 2018.