NCT04129944

A Study to Assess the Safety and Efficacy of a Single Dose of UBX0101 in Patients With Osteoarthritis of the Knee

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of UBX0101 in Moderate to Severe, Painful Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Unity Biotechnology, Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A study to assess efficacy, safety, and tolerability of a single-dose intra-articular administration of UBX0101 in patients with moderate to severe painful knee osteoarthritis (OA).

Detailed description

This is a randomized, double-blind, placebo-controlled, single-dose, parallel-group study to assess the efficacy, safety, and tolerability of a single-dose intra-articular (IA) administration of UBX0101 in patients with moderate to severe painful knee osteoarthritis (OA). Approximately 180 patients will be randomized (1:1:1:1) to one of four treatment groups (three dose levels of UBX0101 and Placebo; approximately 45 patients per group), all administered by IA route at Week 0. The four treatment groups will be enrolled concurrently. The primary objective of the study is to evaluate the effect of IA administration of UBX0101 on the change from baseline to Week 12 of pain in the target knee.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	UBX0101	Investigational drug intra-articular injection
OTHER	Placebo	Placebo intra-articular injection

Timeline

• Start date: 2019-10-30
• Primary completion: 2020-05-20
• Completion: 2020-08-07
• First posted: 2019-10-17
• Last updated: 2021-12-29
• Results posted: 2021-12-29

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study