Long-Term Follow-Up Study of Patients With Osteoarthritis of the Knee Treated With UBX0101 or Placebo

Knee Osteoarthritis Clinical Trial

Official title:

Long-Term Follow-Up Study of Patients With Moderate to Severe, Painful Osteoarthritis of the Knee Who Participated in a Randomized, Placebo-Controlled Study of UBX0101

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04349956
• Other study ID #: UBX0101-05
• Status: Terminated
• Start date: April 20, 2020
• Est. completion date: November 2, 2020

Study information

• Verified date: November 2020
• Source: Unity Biotechnology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A follow-up study to assess the long-term safety of intra-articular (IA) administration of UBX0101 in patients with painful knee osteoarthritis (OA).

Description:

This is a blinded, multi-center study to provide approximately 1 additional year of follow-up for patients with knee OA who participated in a randomized placebo-controlled study of IA UBX0101. No intervention is planned and patients will have 4 scheduled visits to collect follow-up assessments. The primary objective is to evaluate long-term safety and tolerability of IA administration of UBX0101 in patients with painful knee OA.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 161
• Est. completion date: November 2, 2020
• Est. primary completion date: November 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients with knee OA who have completed a randomized placebo-controlled study of UBX0101.

• Patients who are willing and able to consent to having blinded, long-term follow-up; consent via legally authorized representative is not accepted.

Exclusion Criteria:

• Patients with any condition that, in the opinion of the Investigator, would likely interfere with adhering to the study schedule of visits for 12 months.

• Patients who are scheduled to undergo knee arthroplasty on either knee during the study.

• Patients who anticipate arthroscopic surgery on either knee at any time during the study.

• Patients who plan to receive treatment with an anti-nerve growth factor agent during the study.

• Patients who plan to participate in another investigational study (including interventional studies of investigational drugs and investigational treatments [e.g., braces, stem cells, and procedures]) during the study.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• UBX0101 or placebo
This is an observational study. No intervention is administered.

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials	Albuquerque	New Mexico
United States	Hassman Research Institute	Berlin	New Jersey
United States	Chicago Clinical Research Institute	Chicago	Illinois
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Drug Trials America	Hartsdale	New York
United States	Center for Pharmaceutical Research	Kansas City	Missouri
United States	Biosolutions Clinical Research Center	La Mesa	California
United States	Well-Pharma Medical Research	Miami	Florida
United States	Coastal Clinical Research, LLC.	Mobile	Alabama
United States	Arcis Healthcare LLC dba Lowcountry Orthopaedics and Sports Medicine	North Charleston	South Carolina
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Precision Clinical Research	Sunrise	Florida
United States	Fiel Family and Sports Medicine	Tempe	Arizona
United States	Premier Medical Associates	The Villages	Florida
United States	Tucson Orthopaedic Institute	Tucson	Arizona
United States	Diablo Clinical Research	Walnut Creek	California
United States	The Alliance for Multispecialty Research	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Unity Biotechnology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events up to 1 additional year of follow up.		52 weeks