Phase 3 Study to Evaluate the Efficacy and Safety of a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

Phase

Condition

Osteoarthritis

Treatment

N/A

Clinical Study ID

TX223533

Ages 40-80
All Genders

Study Summary

This is a 56-week, placebo controlled study to evaluate the efficacy and safety of the SM04690 injectable suspension 0.07 mg dose in the treatment of knee osteoarthritis (OA). Both patient-reported and radiographic measures will be used to assess efficacy.

Subjects will participate in a 10- to 22-day screening period followed by a single injection and a 6-month evaluation period. Clinic visits will be scheduled at screening visit 1, screening visit 2, Day 1, and weeks 4, 12 and 24. Radiographic images of the knee will be performed at screening visit 1 and week 24.

Subjects will be required to complete a daily electronic diary throughout the study.

Eligibility Criteria

Inclusion

Subjects must have a clinical and radiographic diagnosis of femorotibial OA in the target knee at screening;
OA of the knee is not to be secondary to any rheumatologic conditions.
Subjects must be ambulatory, single assistive devices such as canes are allowed if needed less than 50% of the time.
Subjects requiring a walker are excluded.
Primary source of pain throughout the body must be due to OA in the target knee.
Subjects must have a BMI under 35
Subjects excluded if they have had a single or bilateral, partial or complete knee or hip replacement.

Study Design

Study Description

For more information, please contact the study coordinator, Deb, at deb@alpineresearch.com

Connect with a study center

Alpine Clinical Research Center
Boulder, Colorado 80301
United States
Active - Recruiting

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