Phase II Study to Assess Safety and Efficacy of SL-1002 for Osteoarthritic Knee Pain (NCT05470608) | Clinical Trial Compass
UnknownPhase 2
Phase II Study to Assess Safety and Efficacy of SL-1002 for Osteoarthritic Knee Pain
United States132 participantsStarted 2022-06-13
Plain-language 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.
Who can participate
Age range35 Years
SexALL
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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.
✓. 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.
What they're measuring
1
Occurrence of treatment emergent adverse events (TEAEs) overall
Timeframe: Time of study drug administration to end of study visit (day 168)
2
Improvement of knee pain
Timeframe: Change from baseline to Month 3 in 11 point NRS score
✓. 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: