NCT05248386

Efficacy and Safety of RTX-GRT7039 in Adult Subjects With Knee Osteoarthritis

A Randomized, Double-blind, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of Intra-articular Injections of RTX-GRT7039 in Adult Subjects With Pain Associated With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 469 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated injections of RTX-GRT7039 versus placebo in patients who have pain associated with osteoarthritis of the knee despite standard of care.

Detailed description

This trial comprises a total observation period of up to 52 weeks.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	RTX-GRT7039	RTX-GRT7039 intra-articular injection.
DRUG	Placebo	Placebo matching RTX-GRT7039 intra-articular injection.

Timeline

• Start date: 2022-08-26
• Primary completion: 2024-11-18
• Completion: 2024-11-18
• First posted: 2022-02-21
• Last updated: 2026-03-18
• Results posted: 2025-08-12

Locations

103 sites across 9 countries: Canada, Czechia, France, Germany, Italy, Japan, Mexico, Netherlands, Poland

Regulatory

• FDA-regulated drug study