Osteoarthritis Knee PainPhase 3NCT07226258
Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain
A Phase 3 study testing SL1002 and Normal Saline in people with Osteoarthritis Knee Pain, run by Saol Therapeutics Inc at 22 sites in United States.
Trial summary
A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 for the Treatment of Knee Pain in Patients with Osteoarthritis of the Knee. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis Knee Pain
- What is being tested?
- SL1002 and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 22 sitesUnited States
- Study dates
- 7 Nov 2025to 28 Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥ 40 years of age
- Body Mass Index (BMI) limits
- Chronic knee pain resulting from osteoarthritis
- Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate)
- Baseline KOOS pain
- Patients taking baseline analgesics
- Diagnostic nerve block response
- Compliance with identified study requirements
Who cannot join
- Non-OA inflammatory arthritis
- Confounding elements
- Lower limb amputation.
- Specified alternate historic treatments
- Identified underlying physiologic or psychosocial conditions
- Patient Health Questionnaire
Show all 14Show fewer
- Moderate to severe hepatic impairment
- Moderate to severe renal impairment
- Identifiable baseline medications
- Protocol compliance requirements
- Known allergies or hypersensitivity to identified agents
- Identified alcohol or drug abuse history
- Identified underlying physical exam findings: ECG abnormalities or vital sign abnormalities during study screening per investigator assessment
- Identified underlying abnormal laboratory results
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
University Orthopedics Center
Altoona, Pennsylvania, 16602
Legent Orthopedic and Spine Hospital
Bellaire, Texas, 77401
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Queen City Clinical Research, PLLC
Charlotte, North Carolina, 28211
Prime Medical Research
Coral Gables, Florida, 33134
Institute of Precision Pain Medicine
Corpus Christi, Texas, 78414
Comprehensive Specialty Care
Edmond, Oklahoma, 73034
Pacific Sports and Spine
Eugene, Oregon, 97404
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, 29601
DBPS Research, LLC
Greenwood Village, Colorado, 80111
Conquest Research, LLC
Orlando, Florida, 32832
Virginia iSpine Physicians, PC
Richmond, Virginia, 23238
Mayo Clinic
Rochester, Minnesota, 55905
Sutter Neurology and Pain Management
Roseville, California, 95661
University of Utah Orthopedic Center
Salt Lake City, Utah, 84108
Innovative Pain Treatment Solutions
San Diego, California, 92111
Pain Diagnostics & Interventional Care LLC
Sewickley, Pennsylvania, 15143
Interventional Pain Institute
The Villages, Florida, 32159
International Spine, Pain & Performance Center (IPP)
Tyler, Texas, 75701
International Spine, Pain & Performance Center
Washington D.C., District of Columbia, 20006
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
Conquest Research, LLC
Winter Park, Florida, 32789
About this study
Official title: 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
A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 for the Treatment of Knee Pain in Patients with Osteoarthritis of the Knee.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a single treatment of SL1002 compared to placebo for the treatment of knee pain associated with mild to moderate osteoarthritis.
- Conditions
- Osteoarthritis Knee Pain
- Being tested
- SL1002, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SL1002Drug
SL1002 injectable solution
Normal SalineDrug
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| SL1002 | Experimental | SL1002 Receives: Drug: SL1002 |
| Placebo | Placebo comparator | Normal saline Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 12 in the Weekly Mean of the Average Daily Pain Intensity While Walking
The pain intensity score is measured using a numeric rating scale (NRS)
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start7 Nov 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion28 Feb 2027 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 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
- NCT07226258
- Sponsor's protocol ID
- SL-1010-02
- Status last verified
- Oct 2026
- First submitted
- 6 Nov 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07226258
- Acronym / sponsor ID
- SL-1010-02
- Conditions
- Osteoarthritis Knee Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Saol Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 10 Nov 2025 (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.
A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 for the Treatment of Knee Pain in Patients with Osteoarthritis of the Knee.
Detailed description
This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a single treatment of SL1002 compared to placebo for the treatment of knee pain associated with mild to moderate osteoarthritis.
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 |
|---|---|---|
| SL1002 | Experimental | Drug: SL1002SL1002 |
| Placebo | Placebo comparator | Drug: Normal SalineNormal saline |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients ≥ 40 years of age
- Body Mass Index (BMI) limits
- Chronic knee pain resulting from osteoarthritis
- Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate)
- Baseline KOOS pain
Key exclusion criteria (14 listed)
- Non-OA inflammatory arthritis
- Confounding elements
- Lower limb amputation.
- Specified alternate historic treatments
- Identified underlying physiologic or psychosocial conditions
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 |
|---|---|---|
| SL1002SL1002 injectable solution | Drug | SL1002 |
| Normal SalineNormal Saline | Drug | Placebo |
Primary outcome
Change From Baseline to Week 12 in the Weekly Mean of the Average Daily Pain Intensity While Walking
Time frame: Baseline to week 12
The pain intensity score is measured using a numeric rating scale (NRS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- 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.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SL1002 and Normal Saline in people with Osteoarthritis Knee Pain, run by Saol Therapeutics Inc at 22 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 8 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 to Week 12 in the Weekly Mean of the Average Daily Pain Intensity While Walking (time frame: Baseline to 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 20 Oct 2026.