NCT03769662

Follow on Extension of XT-150-1-0201

XT-150-1-0201 Extension: Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Xalud Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

XT-150 safety and efficacy in severe osteoarthritic pain.

Detailed description

XT-150-1-0201 Extension: Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain. Participants in this study will have been enrolled in the 0201 study and qualify for an intra-articular injection of XT-150 into the osteoarthritic knee. The study will assess XT-150 safety, tolerability, and efficacy in participants who received placebo in the 0201 study, or have a second qualifying knee, or a second injection into the same knee that was treated in 0201.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
BIOLOGICAL	XT-150	IL-10 transgene DNA plasmid injected into the knee synovial capsule

Timeline

• Start date: 2019-03-20
• Primary completion: 2019-10-30
• Completion: 2019-12-30
• First posted: 2018-12-07
• Last updated: 2020-01-18

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study