NCT04124042

Efficacy and Safety of XT-150 in Osteoarthritis of the Knee

A Double-Blind, Placebo-Controlled Assessment of the Tolerability and Efficacy of XT-150 for the Treatment of Moderate to Severe Pain Due to Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 289 (actual)
• Sponsor: Xalud Therapeutics, Inc. · Industry
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 safety and efficacy study of XT-150 in adult participants experiencing moderate to severe pain due to osteoarthritis of the knee.

Detailed description

In this Phase 2 study, Baseline (Day 0) confirmation of study eligibility will be completed the day before or day of study drug administration. Study drug will be administered by intra-articular (IA) injection into the joint space of the index knee (knee selected for treatment). Up to 270 participants will be randomly enrolled into 1 of 6 treatment sequences (45 participants/ group). Treatment Groups: 1. 0.15 mg/mL XT-150 (1mL), 0.15 mg/mL XT-150 (1mL) 2. 0.15 mg/mL XT-150 (1mL), 0.45 mg/mL XT-150 (1mL) 3. 0.45 mg/mL XT-150 (1mL), 0.15 mg/mL XT-150 (1mL) 4. 0.45 mg/mL XT-150 (1mL), 0.45 mg/mL XT-150 (1mL) 5. Placebo (1mL), 0.15 mg/mL XT-150 (1mL) 6. Placebo (1mL), 0.45 mg/mL XT-150 (1mL) The study will be conducted in 2 stages, A and B. Participants will be randomized at Day 0 to a treatment regimen, one treatment assignment for Stage A and one treatment assignment for Stage B: Stage A (Up to Day 180): Participants will receive placebo, 0.15 mg/mL XT-150 or 0.45 mg/mL XT-150 to the index knee at Day 0. Stage B (Day 180 to Day 360): Participants will have the option to receive a pre-randomized dose (XT-150 0.15 mg/mL or 0.45 mg/mL) to the index knee anytime between Day 180 and Day 330. Final assessments will be 12 months after the first IA dose.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
BIOLOGICAL	XT-150	plasmid DNA
DRUG	Placebo	Placebo is a sterile phosphate-buffered saline

Timeline

• Start date: 2020-02-14
• Primary completion: 2022-04-26
• Completion: 2022-04-26
• First posted: 2019-10-11
• Last updated: 2025-03-27
• Results posted: 2025-03-27

Locations

6 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study