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Completed Phase 2 Interventional Results available

Safety and Bone Health Study of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis

ClinicalTrials.gov ID: NCT03727022

Public ClinicalTrials.gov record NCT03727022. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 29, 2026, 12:09 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Bone Health of Multiple Injections of SM04690 Injected in the Target Knee of Moderately to Severely Symptomatic Osteoarthritis Subjects

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary purpose of this phase 2, placebo-controlled, double-blind, parallel group study was to provide an initial safety evaluation of two intra-articular (IA) injections of SM04690 (each at the dose of 0.07mg per 2mL injection) approximately six months apart into the target knee of moderately to severely symptomatic osteoarthritis (OA) subjects. Subjects who completed this 52-week long study were invited to enter the extension phase for an additional 52 weeks of treatment.

Study identification

NCT ID
NCT03727022
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Biosplice Therapeutics, Inc.
Industry
Enrollment
101 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
40 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 27, 2018
Primary completion
Sep 17, 2020
Completion
Aug 17, 2021
Last update posted
Jan 11, 2026

2018 – 2021

United States locations

U.S. sites
13
U.S. states
9
U.S. cities
12
Facility City State ZIP Site status
Research Site Phoenix Arizona 85018 —
Research Site Phoenix Arizona 85053 —
Research Site Canoga Park California 91303 —
Research Site Carmichael California 95628 —
Research Site La Mesa California 91941 —
Research Site Edgewater Florida 32132 —
Research Site Miami Florida 33143 —
Research Site Woodstock Georgia 30189 —
Research Site Kansas City Missouri 64114 —
Research Site Albuquerque New Mexico 87102 —
Research Site Cincinnati Ohio 45246 —
Research Site Charleston South Carolina 29406 —
Research Site San Angelo Texas 76904 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03727022, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 11, 2026 · Synced Sep 29, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03727022 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →