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COMPLETED Phase 3

Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1)

NCT04385303 · View on ClinicalTrials.gov ↗

Study Summary

This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intraarticularly (IA) into the target knee (most painful) joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL injection. This study will utilize patient reported outcomes (PROs) to evaluate the safety and efficacy of lorecivivint.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Lorecivivint

Study Locations (20)

California

  • Research Site — Anaheim
  • Research Site — Beverly Hills
  • Research Site — Canoga Park
  • Research Site — Garden Grove
  • Research Site — La Mesa
  • Research Site — Norco
  • Research Site — Pomona
  • Research Site — San Diego
  • Research Site — Santa Monica
  • Research Site — Thousand Oaks
  • Research Site — Westminster

Alabama

  • Research Site — Birmingham
  • Research Site — Birmingham
  • Research Site — Mobile

Arizona

  • Research Site — Phoenix
  • Research Site — Phoenix
  • Research Site — Tucson

Arkansas

  • Research Site — Little Rock

Colorado

  • Research Site — Boulder

Connecticut

  • Research Site — Hamden

Trial Details

FieldValue
Enrollment Target 496 participants
Start Date 2020-05-26
Est. Completion 2021-09-08
Phase Phase 3

Sponsor

Biosplice Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04385303

The ClinicalTrials.gov registry entry for NCT04385303 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 496 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biosplice Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Knee Osteoarthritis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04385303 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04385303 about?

NCT04385303 is a clinical study titled "Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1)". This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intraarticularly (IA) into the target knee (most painful) joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL inject...

What is the current status of trial NCT04385303?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 496 participants. The study started on 2020-05-26. Estimated completion is 2021-09-08.

What conditions does trial NCT04385303 study?

This clinical trial studies the following conditions: Knee Osteoarthritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04385303?

The interventions under investigation include: Placebo (DRUG), Lorecivivint (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04385303?

This trial is sponsored by Biosplice Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04385303 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial