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NCT04385303 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Knee Osteoarthritis, sponsored by Biosplice Therapeutics.

Completed
Registry status
Phase 3
Development phase
496
Enrollment target
20
Study locations

NCT04385303 is a Phase 3 study of Knee Osteoarthritis that has completed, run by Biosplice Therapeutics. The registered enrollment target is 496 participants, above the 300-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (65% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT04385303, a Phase 3 study of Knee Osteoarthritis, has completed, sponsored by Biosplice Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
496 participants
Enrollment target
20
Study locations

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

Knee Osteoarthritis

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

20 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, categorized as Phase 3. The registered enrollment target is 496 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 300-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (65% higher). The listed sponsor is Biosplice Therapeutics, which has 20 total studies on file at ClinicalTrials.gov.

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.

NCT04385303 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Alabama, Arizona.

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.

What interventions are being tested in trial NCT04385303?

The interventions under investigation include: Placebo (DRUG), Lorecivivint (DRUG).

Who is sponsoring clinical trial NCT04385303?

This trial is sponsored by Biosplice Therapeutics, which has 20 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.