Safety and Bone Health Study of SM04690 for the Treatment of Moderately to Severely Symptomatic K… (NCT03727022) | Clinical Trial Compass
CompletedPhase 2
Safety and Bone Health Study of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
United States101 participantsStarted 2018-11-28
Plain-language summary
The primary purpose of this phase 2, placebo-controlled, double-blind, parallel group study was to provide an initial safety evaluation of two intra-articular (IA) injections of SM04690 (each at the dose of 0.07mg per 2mL injection) approximately six months apart into the target knee of moderately to severely symptomatic osteoarthritis (OA) subjects. Subjects who completed this 52-week long study were invited to enter the extension phase for an additional 52 weeks of treatment.
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion criteria
✓. Males and females between 40 and 80 years of age, inclusive, in general good health
✓. Ambulatory
✓. Diagnosis of femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria at Screening Visit 1 (clinical AND radiographic criteria); OA of the knee is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis)
✓. Pain compatible with OA of the knee(s) for at least 26 weeks prior to Screening Visit 1
✓. Primary source of pain throughout the body is due to OA in the target knee
✓. Daily OA knee pain diary average NRS intensity score ≥ 4 and ≤ 8 in the target knee on the 11-point (0-10) NRS scale for the 7 days immediately preceding Day 1
✓. Pain NRS scores recorded for the target knee on at least 4 out of the 7 days immediately preceding Day 1
✓. Daily OA knee pain diary average NRS intensity score \< 4 in the non-target knee on the 11-point (0-10) NRS scale for the 7 days immediately preceding Day 1
Exclusion criteria
✕. Pregnant and breastfeeding women, and women who are not post-menopausal (defined as 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) and have a positive or indeterminate pregnancy result at Screening Visit 2 or Day 1
✕. Women who are not post-menopausal or permanently surgically sterile, who are sexually active, and who are not willing to use birth control (as outlined in Section 5.3.1) during the study period
What they're measuring
1
Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT
✕. Males who are sexually active and have a partner who is capable of becoming pregnant, neither of whom have had surgery to become sterilized or who are not using birth control as outlined in Section 5.3.1
✕. Body mass index (BMI) \> 35
✕. Partial or complete joint replacement in either knee
✕. Currently requires:
✕. regular use (in the opinion of the Investigator) of ambulatory assistive devices (e.g., wheelchair, parallel bars, walker, canes, or crutches), or
✕. use of a lower extremity prosthesis, and/or a structural knee brace (i.e., a knee brace that contains hardware)