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Wnt Pathway Inhibitor

Lorecivivint for Osteoarthritis

Phase 3

Waitlist Available

Research Sponsored by Biosplice Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 1e (day 1) through visit 3e (week 48)

Awards & highlights

Pivotal Trial

Summary

This trial is testing the safety and effectiveness of lorecivivint injections in patients with knee osteoarthritis who were part of a previous study. The medication aims to reduce pain and improve knee function. Patients will receive injections periodically and be monitored for their symptoms and any side effects.

Eligible Conditions

Osteoarthritis of the Knee
Osteoarthritis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 1e (day 1) through visit 3e (week 48)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 1e (day 1) through visit 3e (week 48)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1e (day 1) through visit 3e (week 48) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Efficacy Outcome: Change from parent-study baseline medial joint space width (mJSW) in the target knee

Primary Safety Outcome: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Secondary study objectives

Change from parent-study baseline OA function in the target knee

Change from parent-study baseline OA pain in the target knee

Side effects data

From 2018 Phase 2 trial • 700 Patients • NCT03122860

Arthralgia

Sinusitis

Upper respiratory tract infection

Invasive ductal breast carcinoma

Joint stiffness

Pain in extremity

Nephrolithiasis

Bronchitis

Urinary tract infection

Viral upper respiratory tract infection

Abdominal tenderness

100%

80%

60%

40%

20%

Study treatment Arm

0.23 mg SM04690

0.07 mg SM04690

0.15 mg SM04690

0.03 mg SM04690

Placebo

Sham

Other

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment2 Interventions

Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1, followed by one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle at Week 48 and every 52 weeks thereafter.

Group II: Arm 1Experimental Treatment1 Intervention

Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Lorecivivint

2019

Completed Phase 3

~1020