Osteoarthritis, Knee PainPhase 2COMPASSNCT05470608
Phase II Study to Assess Safety and Efficacy of SL-1002 for Osteoarthritic Knee Pain
A Phase 2 study testing SL-1002 in people with Osteoarthritis, Knee Pain, run by Saol Therapeutics Inc at 15 sites in United States.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled, single ascending dose escalation study to assess the safety and efficacy of single treatment exposure of an injectable formulation of SL-1002 for the treatment of knee pain associated with osteoarthritis. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Osteoarthritis, Knee Pain
- What is being tested?
- SL-1002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 15 sitesUnited States
- Study dates
- 13 Jun 2022to Jan 2024
- Phase
- Phase 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients 35 years of age or older, with a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2 and a total body weight of ≥50.0 kg for males and ≥45.5 kg for females.
- Patients with chronic knee pain resulting from osteoarthritis for greater than 6 months prior to study Screening Visit 1 that interferes with functional activities (e.g., ambulation, prolonged standing, etc.).
- Patients currently experiencing continued pain despite receiving at least 3 months of conservative treatments, inclusive of activity modification, home exercise, protective weight bearing, and/or use of analgesics (e.g., acetaminophen or NSAIDs).
- Patients with a baseline average pain score of ≥ 6 on an 11-point NRS scale as "usual level of pain over the past 24 hours during weight-bearing activities" for the index knee at Screening. The baseline average pain score is computed by finding the mean of the daily NRS pain intensity scores reported during the 7-day run in period.
- Patients with Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate) radiologically confirmed osteoarthritis (via x-ray/MRI/CT) within 6 months of study Screening Visit 1.
- Patients with a baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score ≥ 19 and ≤ 67 in the index knee.
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- Patients taking analgesics, inclusive of membrane stabilizers (e.g., Neurontin/gabapentin) and/or antidepressants (e.g., Cymbalta/duloxetine), for osteoarthritis associated knee pain must be on a stable dose for at least 6 weeks prior to study Screening Visit 1. Patients must agree to not alter the dose of analgesics for the duration of the study without prior approval from the Investigator.
- Female patients of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration:
- Intra-uterine contraceptive device placed at least 4 weeks prior to study drug administration;
- Male condom with intravaginally applied spermicide starting at least 21 days prior to study drug administration;
- Hormonal contraceptives starting at least 4 weeks prior to study drug administration must agree to use the same hormonal contraceptive throughout the study;
- Sterile male partner (vasectomized since at least 6 months).
- Female patients of non-childbearing potential as defined below:
- Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause).
- Pre-menopausal females with one of the following:
- Documented tubal ligation
- Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
- Hysterectomy
- Documented bilateral oophorectomy.
- Patients must agree to see one treating physician (study Investigator) for knee pain treatment for study duration.
- Patients who have a positive response to a single genicular nerve block of the index knee using 1.5 - 3mL of lidocaine 2% solution administration to the genicular nerves planned for treatment in each cohort (0.5mL per nerve). A positive response to the qualifying lidocaine prognostic block is defined as ≥ 80% pain reduction within 60 minutes of receiving the lidocaine injections and ≥ 80% pain relief for a duration of at least 60 minutes as documented on a standardized 6-hour pain log.
- Patients must be able to understand and be able to complete all assessments associated with the study outcome measures.
- Patients must be able to understand the informed consent and be willing to provide written informed consent. Patients must be able to comply with the requirements of the protocol for the entire duration of the study.
Who cannot join
- 1. Patients with evidence of inflammatory arthritis (e.g., rheumatoid arthritis) or any other systemic inflammatory condition (e.g., gout, pseudogout). 2. Current diagnosis of fibromyalgia. 3. Patients with evidence of neuropathic pain affecting the index knee. 4. Patients with prior or planned lower limb amputation. 5. Patients who have received an intra-articular steroid injection into the index knee within 90 days of study Screening Visit 1. 6. Patients who have received hyaluronic acid injection, Platelet Rich Plasma (PRP), stem cell or arthroscopic debridement/lavage injection into the index knee within 180 days of study Screening Visit
- Patients who have received prior radiofrequency ablation or any other neurolytic procedure of the genicular nerves of the index knee within 1 year of study Screening Visit 1.
- Patients who have received prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware).
- Patients with clinically significant ligamentous laxity of the index knee as per Investigator discretion.
- Patients with clinically significant valgus/varus deformities or evidence of pathology (other than osteoarthritis of the knee) that materially affects gait or function of the index knee or is the underlying cause of the knee pain and/or functional limitations.
- Patients who are extremely thin and those with minimal subcutaneous tissue thickness that could place the patient at risk of a chemical skin burn, at the discretion of the Investigator.
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- Patients with a pending or active compensation claim, litigation or disability remuneration (possibility of secondary gain).
- Patients with chronic pain associated with significant psychosocial dysfunction.
- Patients with a Patient Health Questionnaire - 9 (PHQ-9) score of >10 (indicative of a state of moderate depression).
- Patients with a systemic infection, active joint infection, or localized infection at the planned needle entry sites (patient may be considered for inclusion once infection is resolved).
- Patients with history of uncontrolled coagulopathy or unexplained or uncontrollable bleeding that cannot be corrected, and patients with coagulopathy or who are being treated with anticoagulants.
- Patients with moderate to severe hepatic impairment or moderate to severe renal impairment.
- Identifiable anatomical variability that would materially alter the procedure as described in the protocol.
- Patients currently prescribed opioid medications at a dose of >50 daily morphine equivalents.
- Patients with uncontrolled immunosuppression (e.g., AIDs, cancer, diabetes) as per Investigator discretion.
- Female patients who are pregnant or planning to become pregnant during the duration of the study.
- Female patients who are breast-feeding.
- Patients who are unable or unwilling to comply with the requirements of the protocol.
- Patients taking any of the following concurrent medications/over-the counter products (refer to Appendix 8 in full protocol for a list of applicable medications): c. Probenecid or other organic anion transporter (OAT3) inhibitors. d. Inhibitors of CYP2E1, such as disulfiram.
- Patients with known allergies or hypersensitivity to iodinated contrast medium and gadolinium-based contrast medium. Known allergies or hypersensitivity to phenol and/or lidocaine and/or their excipients.
- Patients with a documented history or evidence of alcohol or drug abuse within 1 year of study screening visit 1.
- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days of study Screening Visit 1, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
- Patients with clinically significant ECG abnormalities or vital sign abnormalities at during study Screening Visit 1. Patients with ECG or vital sign abnormalities deemed nonclinically significant or unlikely to result in clinical compromise by the Principal Investigator may be considered for study inclusion.
- Patients with clinically significant laboratory results (as judged by the Principal Investigator).
- Any condition, in the opinion of the Principal Investigator, that may pose a significant risk to the patient, confound the results of the study or interfere significantly with the patient's participation in the study.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University Orthopedics Center
Altoona, Pennsylvania, 16602
Cooper Neurological Institute
Camden, New Jersey, 08103
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
Prime Medical Research
Coral Gables, Florida, 33134
Institute of Precision Pain Medicine
Corpus Christi, Texas, 78414
Pacific Sports and Spine
Eugene, Oregon, 97404
Denver Spine & Pain Institute
Greenwood Village, Colorado, 80111
Virginia iSpine Physicians
Richmond, Virginia, 23235
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah School of Medicine
Salt Lake City, Utah, 84108
Precision Spine Care
Tyler, Texas, 75701
International Spine, Pain & Performance Center
Washington D.C., District of Columbia, 20006
Center for Clinical Research
Winston-Salem, North Carolina, 27103
Conquest Research
Winter Park, Florida, 32789
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Escalation Study to Assess the Safety and Efficacy of SL-1002 Injectable for Treatment of Knee Pain Associated With Osteoarthritis
This is a multicenter, randomized, double-blind, placebo-controlled, single ascending dose escalation study to assess the safety and efficacy of single treatment exposure of an injectable formulation of SL-1002 for the treatment of knee pain associated with osteoarthritis. Phase A of the study will enroll 3 cohorts of 8 patients per cohort, for a total of 24 patients. Patients will be randomized to receive either SL-1002 or placebo in a 3:1 ratio within each given cohort. Phase B of the study will enroll a minimum of 92 up to a maximum of 108 patients. Patients will be randomized to receive either SL-1002 or placebo in a 3:1 ratio at the recommended dose determined from Phase A. The study period will be up to 168 days inclusive of a screening period of up to 28 days.
- Conditions
- Osteoarthritis, Knee Pain
- Being tested
- SL-1002, Placebo
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SL-1002Drug
SL-1002 injectable solution
PlaceboDrug
Matching placebo injectable solution
| Study group | Role | What they receive |
|---|---|---|
| SL-1002 | Experimental | SL-1002 injectable solution, single dose Receives: Drug: SL-1002 |
| Matching placebo | Placebo comparator | Matching placebo injectable solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of treatment emergent adverse events (TEAEs) overall
TEAE timepoints will be observed from the time point of administration of total dose until end of study visit (day 168)
Measured: Time of study drug administration to end of study visit (day 168)
Improvement of knee pain
Change in weekly average daily pain intensity via Numeric Rating Scale (NRS) score at Month 3
Measured: Change from baseline to Month 3 in 11 point NRS score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start13 Jun 2022
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, Knee PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saol Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470608
- Sponsor's protocol ID
- 1010-01
- Acronym
- COMPASS
- Status last verified
- Aug 2023
- First submitted
- 20 Jul 2022
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Escalation Study to Assess the Safety and Efficacy of SL-1002 Injectable for Treatment of Knee Pain Associated With Osteoarthritis
- ClinicalTrials.gov ID
- NCT05470608
- Acronym / sponsor ID
- COMPASS / 1010-01
- Conditions
- Osteoarthritis, Knee Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Saol Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 22 Jul 2022 (actual)
- 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 is a multicenter, randomized, double-blind, placebo-controlled, single ascending dose escalation study to assess the safety and efficacy of single treatment exposure of an injectable formulation of SL-1002 for the treatment of knee pain associated with osteoarthritis. Phase A of the study will enroll 3 cohorts of 8 patients per cohort, for a total of 24 patients. Patients will be randomized to receive either SL-1002 or placebo in a 3:1 ratio within each given cohort. Phase B of the study will enroll a minimum of 92 up to a maximum of 108 patients. Patients will be randomized to receive either SL-1002 or placebo in a 3:1 ratio at the recommended dose determined from Phase A. The study period will be up to 168 days inclusive of a screening period of up to 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SL-1002 | Experimental | Drug: SL-1002SL-1002 injectable solution, single dose |
| Matching placebo | Placebo comparator | Drug: PlaceboMatching placebo injectable solution |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male or female patients 35 years of age or older, with a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2 and a total body weight of ≥50.0 kg for males and ≥45.5 kg for females.
- Patients with chronic knee pain resulting from osteoarthritis for greater than 6 months prior to study Screening Visit 1 that interferes with functional activities (e.g., ambulation, prolonged standing, etc.).
- Patients currently experiencing continued pain despite receiving at least 3 months of conservative treatments, inclusive of activity modification, home exercise, protective weight bearing, and/or use of analgesics (e.g., acetaminophen or NSAIDs).
- Patients with a baseline average pain score of ≥ 6 on an 11-point NRS scale as "usual level of pain over the past 24 hours during weight-bearing activities" for the index knee at Screening. The baseline average pain score is computed by finding the mean of the daily NRS pain intensity scores reported during the 7-day run in period.
- Patients with Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate) radiologically confirmed osteoarthritis (via x-ray/MRI/CT) within 6 months of study Screening Visit 1.
Key exclusion criteria (25 listed)
- 1. Patients with evidence of inflammatory arthritis (e.g., rheumatoid arthritis) or any other systemic inflammatory condition (e.g., gout, pseudogout). 2. Current diagnosis of fibromyalgia. 3. Patients with evidence of neuropathic pain affecting the index knee. 4. Patients with prior or planned lower limb amputation. 5. Patients who have received an intra-articular steroid injection into the index knee within 90 days of study Screening Visit 1. 6. Patients who have received hyaluronic acid injection, Platelet Rich Plasma (PRP), stem cell or arthroscopic debridement/lavage injection into the index knee within 180 days of study Screening Visit
- Patients who have received prior radiofrequency ablation or any other neurolytic procedure of the genicular nerves of the index knee within 1 year of study Screening Visit 1.
- Patients who have received prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware).
- Patients with clinically significant ligamentous laxity of the index knee as per Investigator discretion.
- Patients with clinically significant valgus/varus deformities or evidence of pathology (other than osteoarthritis of the knee) that materially affects gait or function of the index knee or is the underlying cause of the knee pain and/or functional limitations.
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 |
|---|---|---|
| SL-1002SL-1002 injectable solution | Drug | SL-1002 |
| PlaceboMatching placebo injectable solution | Drug | Matching placebo |
Primary outcome
Occurrence of treatment emergent adverse events (TEAEs) overall
Time frame: Time of study drug administration to end of study visit (day 168)
TEAE timepoints will be observed from the time point of administration of total dose until end of study visit (day 168)
Improvement of knee pain
Time frame: Change from baseline to Month 3 in 11 point NRS score
Change in weekly average daily pain intensity via Numeric Rating Scale (NRS) score at Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- 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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SL-1002 in people with Osteoarthritis, Knee Pain, run by Saol Therapeutics Inc at 15 sites in United States.
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 23 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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?
Results are not available in the source record.
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?
Occurrence of treatment emergent adverse events (TEAEs) overall (time frame: Time of study drug administration to end of study visit (day 168)). 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 29 Aug 2023.