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

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

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

Study Overview

• Status: Terminated
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: UBX0101 or placebo

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 161

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, LLC.
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Fiel Family and Sports Medicine
    • Tucson, Arizona, United States, 85712
      • Tucson Orthopaedic Institute
  • California
    • La Mesa, California, United States, 91942
      • Biosolutions Clinical Research Center
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
  • Florida
    • Miami, Florida, United States, 33143
      • Well-Pharma Medical Research
    • Sunrise, Florida, United States, 33351
      • Precision Clinical Research
    • The Villages, Florida, United States, 32159
      • Premier Medical Associates
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Chicago Clinical Research Institute
  • Kansas
    • Wichita, Kansas, United States, 67207
      • The Alliance for Multispecialty Research
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Center for Pharmaceutical Research
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials
  • New York
    • Hartsdale, New York, United States, 10530
      • Drug Trials America
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc.
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
  • South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Arcis Healthcare LLC dba Lowcountry Orthopaedics and Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate to severe painful knee OA who participated in a randomized, placebo-controlled study of UBX0101 and who consent to having blinded follow-up at the study site for 1 additional year of follow-up. Patients are permitted to take standard-of-care, background medications for OA.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: UBX0101 or placebo; This is an observational study. No intervention is administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events up to 1 additional year of follow up.	52 weeks

Collaborators and Investigators

• Sponsor: Unity Biotechnology, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2020
• Primary Completion (ACTUAL): November 2, 2020
• Study Completion (ACTUAL): November 2, 2020

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (ACTUAL): April 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 13, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Osteoarthritis; Osteoarthritis, Knee; Senescence; Painful Osteoarthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: UBX0101-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No