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

NCT04520607 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2026-03-24

Study results available
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Summary

Study OA-07 was a randomized, double-blind, placebo-controlled, Phase 3, multicenter, 2-year clinical trial that enrolled subjects from the recently completed Study OA-11 (NCT03928184).

The first 48 weeks of OA-07 the trial was placebo-controlled with subjects receiving the same randomized treatment received in OA-11. Investigators, research staff and subjects remained blinded to treatment allocation.

At Week 48, all subjects were administered LOR in the open-label portion of the trial.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Placebo

Healthcare professional-administered intra-articular injection of vehicle.

DRUG

Lorecivivint

Healthcare professional-administered intra-articular injections of lorecivivint.

Sponsors & Collaborators

  • Biosplice Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ismail Simsek, MD · Biosplice Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
41 Years
Max Age
81 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-25
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04520607 on ClinicalTrials.gov