SL-1002 for Osteoarthritic Knee Pain

(COMPASS Trial)

Recruiting at 14 trial locations

Overseen By Sharon Hamm

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Saol Therapeutics Inc

Must be taking: Analgesics

Must not be taking: Opioids, OAT3 inhibitors

Disqualifiers: Inflammatory arthritis, Fibromyalgia, Neuropathic pain, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an injectable medicine called SL-1002 to see if it can reduce knee pain in people with osteoarthritis. The study involves giving patients the medicine and observing the effects. The goal is to find out if a single injection can safely and effectively relieve pain.

Will I have to stop taking my current medications?

The trial does not specify that you must stop taking your current medications. However, if you are taking analgesics (pain relievers), you need to be on a stable dose for at least 6 weeks before the study and cannot change the dose during the study without approval from the study doctor.

Are You a Good Fit for This Trial?

Adults over 35 with a BMI of 18.0-40.0 kg/m2, experiencing knee pain from osteoarthritis for more than 6 months, and not responding to conservative treatments can join this trial. They must have moderate knee arthritis confirmed by imaging, stable medication use, and agree to contraception if applicable. Exclusions include inflammatory conditions like rheumatoid arthritis, recent joint injections or surgery on the knee, drug abuse history, significant heart or lab abnormalities.

Inclusion Criteria

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.

You are 35 years of age or older, and have a BMI of 18.0 to 34.9 kg/m2 and a total body weight of ≥50.0 kg for males and ≥45.5 kg for females.

You have KOOS pain subscale score ≥ 19 and ≤ 67 in the index knee.

Exclusion Criteria

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 currently prescribed opioid medications at a dose of >50 daily morphine equivalents.

Patients with evidence of inflammatory arthritis (e.g., rheumatoid arthritis) or any other systemic inflammatory condition (e.g., gout, pseudogout).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment Phase A

Single ascending dose escalation study with SL-1002 or placebo in 3 cohorts of 8 patients each

Approximately 3 months

Treatment Phase B

Randomized treatment with SL-1002 or placebo at recommended dose from Phase A

Approximately 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 2 months

What Are the Treatments Tested in This Trial?

Interventions

• SL-1002

Trial Overview The study is testing SL-1002's safety and effectiveness in reducing knee pain due to osteoarthritis compared to a placebo. It involves two phases: an initial dose escalation with three groups (24 patients total) followed by a larger phase with up to 108 patients receiving the best dose found in Phase A. Participants are randomly assigned either SL-1002 or placebo at a ratio of 3:1.

How Is the Trial Designed?

Group I: SL-1002 Experimental Treatment 1 Intervention

SL-1002 injectable solution, single dose

Group II: Matching placebo Placebo Group 1 Intervention

Matching placebo injectable solution

Who Is Running the Clinical Trial?

Saol Therapeutics Inc

Lead Sponsor

Trials

3

Recruited

200+