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

Stopped early · Has a placebo group

Conditions studied: Knee Osteoarthritis

In brief

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

Key facts

Study ID

NCT04349956

Run by

Unity Biotechnology, Inc.

People needed

161

Starts

2020-04-20

Expected to finish

2020-11-02

Last updated by the study team

2020-11-17

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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