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TerminatedNCT04349956Updated Nov 17, 2020

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

An observational study in Knee Osteoarthritis, sponsored by Unity Biotechnology, Inc.. Terminated at 17 sites in United States. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-11-17.

Sponsored by Unity Biotechnology, Inc. · Observational

Why this study was terminated
Inability to achieve primary or secondary study objectives
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
161
Ages
40 Years to 85 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Osteoarthritis
  • Painful Osteoarthritis
  • Osteoarthritis, Knee
  • Senescence
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 161 is above the median of 100 across 791 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Unity Biotechnology, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
161 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DrugUBX0101 or placebo

    This is an observational study. No intervention is administered.

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events up to 1 additional year of follow up.

    Time frame: 52 weeks

07

Study locations

17 sites
  • Coastal Clinical Research, LLC.
    Mobile, Alabama 36608, United States
  • Fiel Family and Sports Medicine
    Tempe, Arizona 85283, United States
  • Tucson Orthopaedic Institute
    Tucson, Arizona 85712, United States
  • Biosolutions Clinical Research Center
    La Mesa, California 91942, United States
  • Diablo Clinical Research
    Walnut Creek, California 94598, United States
  • Well-Pharma Medical Research
    Miami, Florida 33143, United States
  • Precision Clinical Research
    Sunrise, Florida 33351, United States
  • Premier Medical Associates
    The Villages, Florida 32159, United States
  • Chicago Clinical Research Institute
    Chicago, Illinois 60607, United States
  • The Alliance for Multispecialty Research
    Wichita, Kansas 67207, United States
  • Center for Pharmaceutical Research
    Kansas City, Missouri 64114, United States
  • Hassman Research Institute
    Berlin, New Jersey 08009, United States
  • Albuquerque Clinical Trials
    Albuquerque, New Mexico 87102, United States
  • Drug Trials America
    Hartsdale, New York 10530, United States
  • Rochester Clinical Research, Inc.
    Rochester, New York 14609, United States
  • Altoona Center for Clinical Research
    Duncansville, Pennsylvania 16635, United States
  • Arcis Healthcare LLC dba Lowcountry Orthopaedics and Sports Medicine
    North Charleston, South Carolina 29406, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04349956
Lead sponsor
Unity Biotechnology, Inc.
Responsible party
Sponsor
First posted
Apr 16, 2020
Start date
Apr 20, 2020
Primary completion
Nov 2, 2020
Completion
Nov 2, 2020
Last update
Nov 17, 2020

Study contacts

Medical Monitor
study director · UNITY Biotechnology

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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