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

Launched by UNITY BIOTECHNOLOGY, INC. · Apr 13, 2020

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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.