An Observational Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis

Biosplice Therapeutics

Status: Completed

Conditions: Osteoarthritis

Treatments: Other: Not applicable (no therapy is administered as part of this study)

Study type: Observational

Funder types: Industry

Identifiers

NCT02951026

SM04690-OA-05

Details and patient eligibility

About

This long-term extension study is designed to monitor the long-term safety, tolerability, and efficacy of treatment of SM04690 or placebo previously injected in the target knee joints of subjects with moderately to severely symptomatic osteoarthritis (OA) from a Samumed-sponsored SM04690-OA phase 2 or phase 3 study. No additional SM04690 or placebo therapy will be administered in this study.

Enrollment: 703 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completion of scheduled end-of-study visit of Samumed-sponsored SM04690-OA phase 2 or phase 3 studies
• Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
• Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed

Exclusion criteria

• Unable to undergo the radiograph procedures detailed within the protocol
• Partial or complete joint replacement in the target knee
• Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site
• Subjects employed by Samumed, LLC, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study

Trial design

703 participants in 4 patient groups

0.03mg SM04690 (previously injected)

Description:

Subjects in this group received a single intra-articular injection of 0.03mg SM04690 into the target knee during the "parent" study prior to enrolling in this observational study.

Treatment:

Other: Not applicable (no therapy is administered as part of this study)

0.07mg SM04690 (previously injected)

Description:

Subjects in this group received a single intra-articular injection of 0.07mg SM04690 into the target knee during the "parent" study prior to enrolling in this observational study.

Treatment:

Other: Not applicable (no therapy is administered as part of this study)

0.23mg SM04690 (previously injected)

Description:

Subjects in this group received a single intra-articular injection of 0.23mg SM04690 into the target knee during the "parent" study prior to enrolling in this observational study.

Treatment:

Other: Not applicable (no therapy is administered as part of this study)

Placebo (previously injected)

Description:

Subjects in this group received a single intra-articular injection of placebo into the target knee during the "parent" study prior to enrolling in this observational study.

Treatment:

Other: Not applicable (no therapy is administered as part of this study)