Single-dose SL1002 to relieve knee osteoarthritis pain
A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 Injectable for the Treatment of Knee Pain in Patients With Osteoarthritis of the Knee
This study will test whether a single dose of SL1002 reduces knee pain in adults 40 and older with mild to moderate osteoarthritis of the knee.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Saol Therapeutics Inc Industry-sponsored |
| Locations | 20 sites (San Diego, California and 19 other locations) |
| Trial ID | NCT07226258 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled phase III trial comparing a single treatment of SL1002 to normal saline for knee pain from mild to moderate osteoarthritis (Kellgren-Lawrence grade 2–3). Adults aged 40 and older with chronic knee pain who meet screening criteria, including a positive diagnostic nerve block response, may be enrolled and continue stable baseline analgesics. Participants are randomized to receive either SL1002 or placebo and are followed for safety and pain outcomes after the single dose. The study is conducted at multiple clinical research sites in the United States.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 or older with chronic knee pain from mild to moderate osteoarthritis (KL grade 2–3), meeting BMI limits, responsive to a diagnostic nerve block, and able to attend study visits at a participating site.
Not a fit: Patients with non-osteoarthritis inflammatory arthritis, severe (KL grade 4) disease, significant hepatic or renal impairment, certain medication conflicts, or relevant allergies or recent substance abuse are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, SL1002 could offer meaningful single-dose pain relief for knee osteoarthritis and reduce reliance on daily systemic pain medications.
How similar studies have performed: Early-phase trials of SL1002 or similar single-dose local or nerve-targeted therapies have shown mixed but sometimes promising signals, so a phase III trial is being done to confirm benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria includes: 1. Male or female patients ≥ 40 years of age 2. Body Mass Index (BMI) limits 3. Chronic knee pain resulting from osteoarthritis 4. Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate) 5. Baseline KOOS pain 6. Patients taking baseline analgesics 7. Diagnostic nerve block response 8. Compliance with identified study requirements Exclusion Criteria includes: 1. Non-OA inflammatory arthritis 2. Confounding elements 3. Lower limb amputation. 4. Specified alternate historic treatments 5. Identified underlying physiologic or psychosocial conditions 6. Patient Health Questionnaire 7. Moderate to severe hepatic impairment 8. Moderate to severe renal impairment 9. Identifiable baseline medications 10. Protocol compliance requirements 11. Known allergies or hypersensitivity to identified agents 12. Identified alcohol or drug abuse history 13. Identified underlying physical exam findings: ECG abnormalities or vital sign abnormalities during study screening per investigator assessment 14. Identified underlying abnormal laboratory results
Where this trial is running
San Diego, California and 19 other locations
- Innovative Pain Treatment Solutions — San Diego, California, United States (Recruiting)
- DBPS Research, LLC — Greenwood Village, Colorado, United States (Recruiting)
- International Spine, Pain & Performance Center — Washington D.C., District of Columbia, United States (Recruiting)
- Prime Medical Research — Coral Gables, Florida, United States (Recruiting)
- Conquest Research, LLC — Orlando, Florida, United States (Recruiting)
- Conquest Research, LLC — Winter Park, Florida, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Queen City Clinical Research, PLLC — Charlotte, North Carolina, United States (Recruiting)
- The Center for Clinical Research — Winston-Salem, North Carolina, United States (Recruiting)
- Comprehensive Specialty Care — Edmond, Oklahoma, United States (Recruiting)
- Pacific Sports and Spine — Eugene, Oregon, United States (Recruiting)
- University Orthopedics Center — Altoona, Pennsylvania, United States (Recruiting)
- Pain Diagnostics & Interventional Care LLC — Sewickley, Pennsylvania, United States (Recruiting)
- Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States (Recruiting)
- PCPMG Clinical Research Unit, LLC — Greenville, South Carolina, United States (Recruiting)
- Legent Orthopedic and Spine Hospital — Bellaire, Texas, United States (Recruiting)
- Institute of Precision Pain Medicine — Corpus Christi, Texas, United States (Recruiting)
- International Spine, Pain & Performance Center (IPP) — Tyler, Texas, United States (Recruiting)
- University of Utah Orthopedic Center — Salt Lake City, Utah, United States (Recruiting)
- Virginia iSpine Physicians, PC — Richmond, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Kiki Diorgu, M.D.
- Email: info@saolrx.com
- Phone: 770-274-2827
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.