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

February 26, 2026 updated by: Grünenthal GmbH

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

714

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • UMHAT Pulmed
      • Plovdiv, Bulgaria, 4002
        • MHAT Kaspela EOOD
      • Plovdiv, Bulgaria, 4000
        • UMHAT Eurohospital Plovdiv OOD
      • Plovdiv, Bulgaria, 4002
        • Medical Centre Artmed
      • Plovdiv, Bulgaria, 4002
        • University Multiprofile Hospital for Active Treatment Pulmed OOD
      • Sofia, Bulgaria, 1000
        • Medical Centre N. I. Pirogov EOOD
      • Sofia, Bulgaria, 1612
        • MHAT St Iv. Rilski
      • Sofia, Bulgaria, 1612
        • UMBAL Sveti Ivan Rilski EAD
      • Sofia, Bulgaria, 1784
        • Synexus Medical Center Sofia
      • Veliko Tarnovo, Bulgaria, 5000
        • Multi-Profile District Hospital for Active Treatment Dr. Stefan Cherkezov
  • Japan
      • Saitama, Japan, 350-8550
        • Saitama Medical Center
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 8140180
        • Fukuoka University Hospital
      • Okawa-shi, Fukuoka, Japan, 831-0016
        • Medical Corporation Kouhoukai Takagi Hospital
    • Hokkaido
      • Hakodate, Hokkaido, Japan, 040-8585
        • Hakodate Central General Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 221-0821
        • Saiseikai Kanagawaken Hospital
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 169-0073
        • Otakibashi Orthopedic Clinic
  • Poland
      • Bialystok, Poland, 15-879
        • ClinicMed Badurski i Wspolnicy Spolka Jawna
      • Bialystok, Poland, 15-879
        • ClinicMed Daniluk, Nowak Spolka Komandytowa
      • Bolesławiec, Poland, 59-700
        • Zaklad Opieki Zdrowotnej w Boleslawcu
      • Elblag, Poland, 82-300
        • Centrum Kliniczno
      • Gliwice, Poland, 44-100
        • NZOZ Medi Spatz
      • Kielce, Poland, 25-017
        • PZU Zdrowie S.A. Oddzia¿ Centrum Medyczne Artimed w Kielcach
      • Krakow, Poland, 31-141
        • Centrum Medyczne Semper fortis
      • Krakow, Poland, 31-530
        • CenterMed Kraków Sp. z o.o.
      • Krakow, Poland, 31-530
        • Nzoz Centermed Krakow, Szpital I Przychodnia
      • Olsztyn, Poland, 10-117
        • Etyka Osrodek Badan Klinicznych
      • Poznan, Poland, 60-218
        • Medyczne Centrum Hetmańska
      • Poznan, Poland, 60-218
        • Medyczne Centrum Hetmanska Indywidualna Specjalistyczna Praktyka Lekarska Dr Hab Piotr Leszczynski
      • Sochaczew, Poland, 96-500
        • RCMed Oddzial Sochaczew
      • Sochaczew, Poland, 96-500
        • RCMed Piotr Opadczuk
      • Warsaw, Poland, 02-793
        • ETG Warszawa
      • Warsaw, Poland, 02-677
        • ETG Warszawa
      • Warsaw, Poland, 02-777
        • Europejskie Centrum leczenia Chorob Cywilizacyjnych
      • Świdnik, Poland, 21040
        • Lubelskie Centrum Diagnostyczne
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-556
        • Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
    • Malopolska
      • Krakow, Malopolska, Poland, 31141
        • Centrum Medyczne 4M Plus
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-777
        • ETG Warszawa
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-736
        • Wojewodzki Szpital Zespolony w Kielcach
  • Romania
      • Brasov, Romania, 500283
        • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
      • Bucharest, Romania, 030463
        • SC Policlinica CCBR SRL
      • Bucharest, Romania, 020475
        • Spital Clinic Dr I Cantacuzino
      • Bucharest, Romania, 11172
        • Sf. Maria Hospital
      • Bucharest, Romania, 011025
        • SC Centrul Medical Sana SRL
      • Bucharest, Romania, 011172
        • Spitalul Clinic Sf. Maria
    • Olt
      • Caracal, Olt, Romania, 235200
        • Spitalul Judetean Caracal
    • Timiș County
      • Timișoara, Timiș County, Romania, 300362
        • SC Medicali's SRL
    • Vâlcea County
      • Râmnicu Vâlcea, Vâlcea County, Romania, 240762
        • SC Medaudio-Optica SRL
  • South Africa
      • Cape Town, South Africa, 7405
        • Arthritis Clinical Research Centre
    • Cape Town
      • Parow, Cape Town, South Africa, 7500
        • TREAD Research
      • Parow, Cape Town, South Africa, 7500
        • Tygerberg Hospital
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Josha Research
      • Welkom, Free State, South Africa, 9460
        • Welkom Clinical Trial Centre
    • Gauteng
      • Benoni, Gauteng, South Africa
        • Worthwhile Clinical Trials
      • Halfway House, Gauteng, South Africa, 1685
        • Midrand Medical Centre
      • Johannesburg, Gauteng, South Africa, 1500
        • Lakeview Hospital
      • Pretoria, Gauteng, South Africa, 0002
        • University of Pretoria
      • Pretoria, Gauteng, South Africa, 0001
        • Global Clinical Trials
      • Roodepoort, Gauteng, South Africa, 1724
        • Roodepoort Medicross Clinical Research Centre
      • Sandton, Gauteng, South Africa, 2196
        • Sandton Medical Research (Newtown CRC)
    • Johannesburg
      • Kempton Park, Johannesburg, South Africa, 1619
        • Clinresco Centres (Pty) Ltd.
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Synapta Clinical Research Center
      • Durban, KwaZulu-Natal, South Africa, 4091
        • Dr Zubar Fazal Ahmed Vawda MD
      • Durban, KwaZulu-Natal, South Africa, 4092
        • Precise Clinical Solutions
      • eMkhomazi, KwaZulu-Natal, South Africa, 4170
        • Aliwal Shoal Medical Centre
    • Western Cape
      • Kraaifontein, Western Cape, South Africa, 7570
        • Medicross Langeberg Medical & Dental Centre
      • Kraaifontein, Western Cape, South Africa, 7572
        • Medicross Langeberg Medical & Dental Centre
  • United Kingdom
      • Coventry, United Kingdom, CV3 4FJ
        • Accellacare Warwickshire
      • Leeds, United Kingdom, LS7 4SA
        • Chapel Allerton Hospital - Leeds Teaching Hospitals NHS Trust
    • Yorkshire
      • Shipley, Yorkshire, United Kingdom, BD18 3SA
        • Accellacare Yorkshire
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Arizona Arthritis and Rheumatology Associates (AARA) P.C
      • Phoenix, Arizona, United States, 85018
        • Elite Clinical Studies, LLC
    • California
      • Anaheim, California, United States, 92801
        • Orange County Research Institute
      • San Diego, California, United States, 92120
        • Acclaim Clinical Research, Inc.
      • Thousand Oaks, California, United States, 91360
        • Westlake Medical Research
    • Florida
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
      • Sarasota, Florida, United States, 34232
        • Gulfcoast Research Institute
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
    • Georgia
      • Woodstock, Georgia, United States, 30189
        • North Georgia Clinical Research
    • Idaho
      • Boise, Idaho, United States, 83713
        • Injury Care Research
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Chicago Clinical Research Institute Inc.
    • Indiana
      • Greenwood, Indiana, United States, 46143
        • OrthoIndy, Inc.
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
      • Overland Park, Kansas, United States, 66210
        • Neuroscience Research Center, LLC
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Clinical Pharmacology Study Group
    • Michigan
      • Troy, Michigan, United States, 48085
        • Oakland Medical Research Center
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Excel Clinical Research
      • North Las Vegas, Nevada, United States, 89030
        • Las Vegas Clinical Trials, LLC
    • New York
      • Hartsdale, New York, United States, 10530
        • Drug Trials America
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • M3-Emerging Medical Research, LLC
      • Raleigh, North Carolina, United States, 27704
        • M3-Emerging Medical Research, LLC
    • Pennsylvania
      • State College, Pennsylvania, United States, 16801
        • University Orthopedics Center
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
      • North Charleston, South Carolina, United States, 29405
        • Coastal Carolina Research Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37912
        • Accellacare-Knoxville
    • Texas
      • San Antonio, Texas, United States, 78229
        • Tekton Research, Inc.
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: RTX-GRT7039
RTX-GRT7039 monoarticular injections or bilateral intra-articular injections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: From Baseline up to Week 78
From Baseline up to Week 78
Number of Participants With TEAEs Leading to Study Discontinuation
Time Frame: From Baseline up to Week 78
From Baseline up to Week 78

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With TEAEs Representing Structural Changes as Assessed by Imaging Methods
Time Frame: From Baseline up to Week 78
From Baseline up to Week 78
Change From Baseline in WOMAC Pain Subscale Score
Time Frame: From Baseline up to Week 12
The WOMAC pain subscale will be assessed using an 11-point numerical rating scale (NRS), where 0= no pain and 10=worst pain.
From Baseline up to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grünenthal GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2022

Primary Completion (Actual)

May 15, 2025

Study Completion (Actual)

May 15, 2025

Study Registration Dates

First Submitted

May 12, 2022

First Submitted That Met QC Criteria

May 12, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KF7039-03
  • 2021-005046-15 (EudraCT Number)
  • U1111-1268-7230 (Other Identifier: Universal Trial Number)
  • 2024-515709-24-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Information available on the Grünenthal Group Web Site (see URL below for details); according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Data Sharing Principles.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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