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

Unity Biotechnology

Status: Terminated

Conditions: Knee Osteoarthritis

Treatments: Drug: UBX0101 or placebo

Study type: Observational

Funder types: Industry

Identifiers

NCT04349956

UBX0101-05

Details and patient eligibility

About

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

Full 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.

Enrollment: 161 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

161 participants in 1 patient group

Patients from a randomized placebo-controlled study of UBX0101

Description:

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

Treatment:

Drug: UBX0101 or placebo