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

NCT ID: NCT04349956

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-20

Study Completion Date

2020-11-02

Brief Summary

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

Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Keywords

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Osteoarthritis Painful Osteoarthritis Osteoarthritis, Knee Senescence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients from a randomized placebo-controlled study of UBX0101

Patients with moderate to severe, painful OA of the knee who participated in a randomized, placebo-controlled study of UBX0101.

UBX0101 or placebo

Intervention Type DRUG

This is an observational study. No intervention is administered.

Interventions

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UBX0101 or placebo

This is an observational study. No intervention is administered.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unity Biotechnology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

UNITY Biotechnology

Locations

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Coastal Clinical Research, LLC.

Mobile, Alabama, United States

Site Status

Fiel Family and Sports Medicine

Tempe, Arizona, United States

Site Status

Tucson Orthopaedic Institute

Tucson, Arizona, United States

Site Status

Biosolutions Clinical Research Center

La Mesa, California, United States

Site Status

Diablo Clinical Research

Walnut Creek, California, United States

Site Status

Well-Pharma Medical Research

Miami, Florida, United States

Site Status

Precision Clinical Research

Sunrise, Florida, United States

Site Status

Premier Medical Associates

The Villages, Florida, United States

Site Status

Chicago Clinical Research Institute

Chicago, Illinois, United States

Site Status

The Alliance for Multispecialty Research

Wichita, Kansas, United States

Site Status

Center for Pharmaceutical Research

Kansas City, Missouri, United States

Site Status

Hassman Research Institute

Berlin, New Jersey, United States

Site Status

Albuquerque Clinical Trials

Albuquerque, New Mexico, United States

Site Status

Drug Trials America

Hartsdale, New York, United States

Site Status

Rochester Clinical Research, Inc.

Rochester, New York, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Arcis Healthcare LLC dba Lowcountry Orthopaedics and Sports Medicine

North Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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UBX0101-05

Identifier Type: -

Identifier Source: org_study_id