A Single-arm, Open-label, Phase III Trial to Evaluate the Safety and Tolerability of Intra-articular Injections of RTX-GRT7039 in Subjects With Moderate to Severe Pain Associated With Osteoarthritis of the Knee.

Grünenthal GmbH178 sites in 4 countries714 target enrollmentSeptember 15, 2022

ConditionsOsteoarthritis

InterventionsRTX-GRT7039

Overview

Phase: Phase 3
Intervention: RTX-GRT7039
Conditions: Osteoarthritis
Sponsor: Grünenthal GmbH
Enrollment: 714
Locations: 178
Primary Endpoint: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

An open-label, single-arm clinical trial to confirm the safety of monoarticular injections or bi-lateral intra-articular injections of RTX-GRT7039 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 78 weeks.

Registry

clinicaltrials.gov

Start Date

September 15, 2022

End Date

May 15, 2025

Last Updated

last month

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Grünenthal GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The participant has given written informed consent to participate.
•The participant is 18 years of age or older at the Screening Visit.
•The participant has a diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I to III.
•There is a documented history indicating that participant has insufficient pain relief with previous Standard of Care.

Exclusion Criteria

•The participant has past joint replacement surgery of the index knee.
•The participant has a history of significant trauma or surgery (e.g., open or arthroscopic) to the index knee within 12 months of Screening.
•The participant has periarticular pain at the index knee from any cause other than osteoarthritis, including referred pain, bursitis, tendonitis.
•The participant has clinical hip osteoarthritis on the side of the index knee.
•The participant has a history of osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, rapidly progressing osteoarthritis (RPOA) Type I or Type II,pathologic fracture, primary or metastatic tumor, or joint infection in the index knee.
•The participant has significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus \>10°, valgus \>10°) by radiograph as assessed by independent Central Readers at Screening Visit.
•The participant has other conditions that could affect trial endpoint assessments of the index knee.
•The participant has current clinically significant disease(s) or condition(s) that may affect safety assessments, or any other reason which may preclude the participant's participation for the full duration of the trial.
•The participant has a history of hypersensitivity to resiniferatoxin (RTX) or any similar component (capsaicin, chili peppers).
•The participant is currently participating or was participating in another investigational drug trial within 3 months prior to the Screening Visit.

Arms & Interventions

RTX-GRT7039

Participants will receive injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with highest pain intensity), or each of both knees up to Week 52.

Intervention: RTX-GRT7039

Outcomes

Primary Outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time Frame: From Baseline up to Week 78

Number of Participants With TEAEs Leading to Study Discontinuation

Time Frame: From Baseline up to Week 78

Secondary Outcomes

Number of Participants With TEAEs Representing Structural Changes as Assessed by Imaging Methods(From Baseline up to Week 78)
Change From Baseline in WOMAC Pain Subscale Score(From Baseline up to Week 12)