Trials / Terminated
TerminatedNCT04349956
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
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 161 (actual)
- Sponsor
- Unity Biotechnology, Inc. · Industry
- Sex
- All
- Age
- 40 Years – 85 Years
- Healthy volunteers
- Not accepted
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).
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | UBX0101 or placebo | This is an observational study. No intervention is administered. |
Timeline
- Start date
- 2020-04-20
- Primary completion
- 2020-11-02
- Completion
- 2020-11-02
- First posted
- 2020-04-16
- Last updated
- 2020-11-17
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04349956. Inclusion in this directory is not an endorsement.