Clinical trial NCT04520607: A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee
Official title: A Long-Term Extension Study Evaluating the Safety and Efficacy of Lorecivivint in Subjects With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Keywords: SM04690
Wnt pathway inhibitor
osteoarthritis
Biosplice Therapeutics, Inc.
Samumed
lorecivivint
Lead sponsor: Biosplice Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-20
Enrollment: 276
Sex: ALL
Minimum age (years): 41
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: At the first visit (Day 1), all subjects will complete Patient Acceptable Symptom State (PASS) and pain Numeric Rating Scale (NRS) assessments and then receive a blinded study injection into their target knee (the same target knee injected in the parent study), with subjects receiving the same treatment (either 0.07 mg LOR or placebo) as they received in the parent study. Subjects will have clinic visits for pain and function assessments, collection of adverse events, and knee radiographs. At Week 48, all subjects, regardless of previous treatment, will receive an injection of 0.07 mg LOR into their target knee. Subjects will receive injections of 0.07 mg LOR into their target knee every 52 weeks thereafter until end of study.

Eligibility 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

Primary outcomes:
measure: Primary Safety Outcome: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Visit 1E (Day 1) through Visit 3E (Week 48)
measure: Primary Efficacy Outcome: Change from parent-study baseline medial joint space width (mJSW) in the target knee
timeFrame: Parent-study baseline; Visit 3E (Week 48)
Secondary outcomes:
measure: Change from parent-study baseline OA pain in the target knee
timeFrame: Parent-study baseline; Visit 2E (Week 24)
measure: Change from parent-study baseline OA function in the target knee
timeFrame: Parent-study baseline; Visit 2E (Week 24)
measure: Change from parent-study baseline OA pain in the target knee
timeFrame: Parent-study baseline; Visit 3E (Week 48)
measure: Change from parent-study baseline OA function in the target knee
timeFrame: Parent-study baseline; Visit 3E (Week 48)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Anaheim
country: United States
facility: Research Site
state: California
city: Pomona
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Thousand Oaks
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Miami Lakes
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Port Orange
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Winter Haven
country: United States
facility: Research Site
state: Florida
city: Winter Park
country: United States
facility: Research Site
state: Florida
city: Newnan
country: United States
facility: Research Site
state: Georgia
city: Woodstock
country: United States
facility: Research Site
state: Georgia
city: Gurnee
country: United States
facility: Research Site
state: Illinois
city: Oak Brook
country: United States
facility: Research Site
state: Illinois
city: Valparaiso
country: United States
facility: Research Site
state: Indiana
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Bay City
country: United States
facility: Research Site
state: Michigan
city: Troy
country: United States
facility: Research Site
state: Michigan
city: Hazelwood
country: United States
facility: Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Hartsdale
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Salisbury
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Fort Mill
country: United States
facility: Research Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Research Site
state: South Carolina
city: Rapid City
country: United States
facility: Research Site
state: South Dakota
city: Carrollton
country: United States
facility: Research Site
state: Texas
city: Plano
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Draper
country: United States
facility: Research Site
state: Utah
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: Biosplice Therapeutics, Inc.
name: Ismail Simsek, MD
role: STUDY_DIRECTOR
References: