Overview

A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee

Status:
Recruiting
Trial end date:
2024-09-01
Target enrollment:
0
Participant gender:
All
Summary
This study is designed as a long-term extension to the Phase 3 parent-study SM04690-OA-11. It aims to evaluate the safety and efficacy of long-term use of lorecivivint (LOR) in subjects with knee osteoarthritis (OA). The first 48 weeks will be single-blind and placebo-controlled while the remainder of the study will be open-label and uncontrolled. Subjects must enroll no later than 6 weeks following completion of the parent-study.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Biosplice Therapeutics, Inc.
Samumed LLC
Treatments:
Adavivint
Lorecivivint
Criteria
Inclusion Criteria:

1. Completion of the Samumed study SM04690-OA-11

2. Compliance with procedures in study SM04690-OA-11, in the opinion of the Investigator

3. Fully understanding study requirements and willingness to comply with study visits and
assessments

4. Understanding and signing of the informed consent form (ICF) prior to any
study-related procedures

Exclusion Criteria:

1. Any condition that, in the opinion of the Investigator, constitutes a risk or
contraindication for participation in the study or that could interfere with the study
objectives, conduct, or evaluation

2. Any contraindications for an intra-articular (IA) injection in the target knee in the
opinion of the Investigator

3. Any known reason identified by the Investigator or Sponsor that the subject may not be
compliant with study visits or may no longer be an appropriate candidate for the study
(e.g. planned major surgery, knee replacement during the parent study, planning to
move away from the research site, or initiation of a prohibited concomitant medication
including, but not limited to, IA injection of glucocorticoids, hyaluronic acid
derivatives, platelet-rich plasma, stem cell therapies, or other agents with
therapeutic intent into the target knee)

4. Participation in a clinical research trial (other than the prior SM04690-OA-11 study)
that included the receipt of an investigational product (IP) or any experimental
therapeutic procedure within 12 weeks before any study injection, or planned
participation in any such trial

5. Current or pending disability claim, workers' compensation, or litigation(s) that may
compromise response to treatment

6. Pregnant women, 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) who have a positive or indeterminate pregnancy test result at Visit 1E
(Day 1)

7. 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 the protocol)
during the study period