Phase II Study to Assess Safety and Efficacy of SL-1002 for Osteoarthritic Knee Pain

NCT05470608 | Unknown Phase 2 FDA Drug

• 1 other identifier: 1010-01
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 15

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  Change from baseline to Month 3 in 11 point NRS score

Study Arms (2)

SL-1002

EXPERIMENTAL

SL-1002 injectable solution, single dose

Drug: SL-1002

Matching placebo

PLACEBO COMPARATOR

Matching placebo injectable solution

Drug: Placebo

Interventions

SL-1002 DRUG

SL-1002 injectable solution

SL-1002

Placebo DRUG

Matching placebo injectable solution

Matching placebo

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

You may not qualify if:

• \. 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.
• 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 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.

Sponsors & Collaborators

• Saol Therapeutics Inc: lead

Study Sites (15)

Denver Spine & Pain Institute

Greenwood Village, Colorado, 80111, United States

Location

International Spine, Pain & Performance Center

Washington D.C., District of Columbia, 20006, United States

Location

Prime Medical Research

Coral Gables, Florida, 33134, United States

Location

Conquest Research

Winter Park, Florida, 32789, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Cooper Neurological Institute

Camden, New Jersey, 08103, United States

Location

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Pacific Sports and Spine

Eugene, Oregon, 97404, United States

Location

University Orthopedics Center

Altoona, Pennsylvania, 16602, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Institute of Precision Pain Medicine

Corpus Christi, Texas, 78414, United States

Location

Precision Spine Care

Tyler, Texas, 75701, United States

Location

University of Utah School of Medicine

Salt Lake City, Utah, 84108, United States

Location

Virginia iSpine Physicians

Richmond, Virginia, 23235, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 22, 2022
• Study Start: June 13, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)