SL-1002 for Osteoarthritic Knee Pain

(COMPASS Trial)

Not currently recruiting at 15 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new injectable treatment, SL-1002, to determine if it can safely and effectively reduce knee pain from osteoarthritis. Participants will receive either the actual treatment or a placebo (a non-active substance) for comparison. The trial seeks individuals who have experienced knee pain from osteoarthritis for over six months, disrupting daily activities like walking or standing. Participants should have tried other treatments for at least three months with little relief. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that SL-1002 is likely to be safe for humans?

Research has shown that SL-1002 underwent safety testing in earlier studies. In one study on limb spasticity, patients received SL-1002 to assess its tolerability. The results indicated that the treatment was generally safe, with no unexpected side effects, and most patients tolerated it well.

For knee pain caused by osteoarthritis, SL-1002 is currently being tested in a study comparing its safety to a placebo (a treatment with no active drug). This study aims to evaluate the safety of SL-1002 for treating knee pain from osteoarthritis.

As a Phase 2 trial, the treatment has already passed initial safety tests. This suggests researchers have some confidence in its safety for humans, but they continue to gather more information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for osteoarthritic knee pain?

Unlike the standard treatments for osteoarthritic knee pain, which often include oral pain relievers and corticosteroid injections, SL-1002 offers a novel approach as an injectable solution. Researchers are excited about SL-1002 because it is designed to be a single-dose treatment, which could potentially simplify patient management and improve adherence. Additionally, SL-1002 may work through a new mechanism that targets pain pathways more directly, offering hope for better pain relief compared to existing options.

What evidence suggests that SL-1002 might be an effective treatment for osteoarthritic knee pain?

Researchers are investigating SL-1002 to determine its effectiveness in reducing knee pain from osteoarthritis. In this trial, participants will receive either a single dose of SL-1002 or a matching placebo. Earlier studies found SL-1002 safe for individuals with muscle stiffness, which is promising for its potential use in knee osteoarthritis. Although specific results on its effectiveness for knee pain are not yet available, its safety in other conditions is encouraging. SL-1002 aims to relieve pain with just one injection, offering a potentially convenient option for patients. Further research is underway to confirm its benefits for knee pain from osteoarthritis. ^{1 2 4 6 7}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05470608

Phase II Study to Assess Safety and Efficacy of SL-1002 for ... Patients with Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate) radiologically confirmed osteoarthritis (via x-ray/MRI/CT) within 6 months of study ...

2. saolrx.com saolrx.com/saol-therapeutics-announces-positive-topline-results-from-the-sl-1002-raise-limb-spasticity-trial/

SL-1002 demonstrated a favorable safety ... SL-1002 demonstrated a favorable safety profile in adult patients with limb spasticity, achieving the primary safety endpoint of this first-in-human study.

3. withpower.com withpower.com/trial/phase-2-osteoarthritis-knee-pain-6-2022-d83be

SL-1002 for Osteoarthritic Knee Pain (COMPASS Trial) 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 ...

4. saolrx.com saolrx.com/saol-therapeutics-announces-topline-data-from-the-sl-1002-raise-limb-spasticity-trial-to-be-presented-at-spasticity-x-the-first-international-spasticity-symposium-on-october-25-2024/

Saol Therapeutics Announces Topline Data from the SL ... In addition to the RAISE Spasticity Trial, SL-1002 is also being investigated for the treatment of pain related to osteoarthritis of the knee.

5. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/osteoarthritis

Osteoarthritis Clinical Trials - Mayo Clinic Research A study to compare the safety of single ascending doses of SL-1002 to a placebo and the efficacy of a single treatment exposure of SL-1002 to relieve pain in ...

6. saolrx.com saolrx.com/saol-therapeutics-announces-completion-of-enrollment-in-both-the-phase-ii-compass-osteoarthritis-knee-pain-trial-and-the-phase-ii-raise-limb-spasticity-trial/

Saol Therapeutics News The safety of SL-1002 will be assessed throughout the study compared to placebo when used for treating chronic knee pain associated with ...

7. prnewswire.com prnewswire.com/news-releases/saol-therapeutics-announces-first-patient-enrolled-in-phase-2-compass-trial-evaluating-the-safety-and-efficacy-profile-of-sl-1002-for-treatment-of-knee-pain-associated-with-osteoarthritis-301602027.html

Saol Therapeutics Announces First Patient Enrolled in ... The safety of SL-1002 will be assessed throughout the study in comparison to placebo when used for the treatment of knee pain associated with ...