Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis of the Knee

Grünenthal

Status and phase: Active, not recruiting; Phase 3

Conditions: Osteoarthritis

Treatments: Drug: RTX-GRT7039

Study type: Interventional

Funder types: Industry

Identifiers

NCT05377489

U1111-1268-7230 (Other Identifier)

2021-005046-15 (EudraCT Number)

KF7039-03

Details and patient eligibility

About

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.

Full description

This trial comprises a total observation period of up to 78 weeks.

Enrollment: 930 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.
• The participant is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site or is a family member of the employees or the investigator.

The non-index knee is not eligible for treatment in the trial, if any of the knee-related exclusion criteria applies to the non-index knee.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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930 participants in 1 patient group

RTX-GRT7039

Experimental group

Description:

Participants will receive up to 5 intra-articular 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.

Treatment:

Drug: RTX-GRT7039