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

NCT05377489 | Completed Phase 3 Results FDA Drug

• 4 other identifiers: KF7039-032021-005046-15U1111-1268-72302024-515709-24-00
• Study Type: interventional
• Target: 714
• Locations: 7 countries
• Sites: 96

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.

Conditions

Osteoarthritis

Keywords

Knee; Osteoarthritis; Pain assessment

Outcome Measures

Primary Outcomes (2)

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

  From Baseline up to Week 78

• Number of Participants With TEAEs Leading to Study Discontinuation

  From Baseline up to Week 78

Secondary Outcomes (2)

• 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

Study Arms (1)

RTX-GRT7039

EXPERIMENTAL

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

Interventions

RTX-GRT7039 DRUG

RTX-GRT7039 monoarticular injections or bilateral intra-articular injections.

RTX-GRT7039

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grünenthal GmbH: lead

Study Sites (96)

Arizona Arthritis and Rheumatology Associates (AARA) P.C

Glendale, Arizona, 85306, United States

Location

Elite Clinical Studies, LLC

Phoenix, Arizona, 85018, United States

Location

Orange County Research Institute

Anaheim, California, 92801, United States

Location

Acclaim Clinical Research, Inc.

San Diego, California, 92120, United States

Location

Westlake Medical Research

Thousand Oaks, California, 91360, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Gulfcoast Research Institute

Sarasota, Florida, 34232, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

North Georgia Clinical Research

Woodstock, Georgia, 30189, United States

Location

Injury Care Research

Boise, Idaho, 83713, United States

Location

Chicago Clinical Research Institute Inc.

Chicago, Illinois, 60607, United States

Location

OrthoIndy, Inc.

Greenwood, Indiana, 46143, United States

Location

University Of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Neuroscience Research Center, LLC

Overland Park, Kansas, 66210, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605, United States

Location

Oakland Medical Research Center

Troy, Michigan, 48085, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

Las Vegas Clinical Trials, LLC

North Las Vegas, Nevada, 89030, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

M3-Emerging Medical Research, LLC

Durham, North Carolina, 27704, United States

Location

M3-Emerging Medical Research, LLC

Raleigh, North Carolina, 27704, United States

Location

University Orthopedics Center

State College, Pennsylvania, 16801, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Accellacare-Knoxville

Knoxville, Tennessee, 37912, United States

Location

Tekton Research, Inc.

San Antonio, Texas, 78229, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

Location

UMHAT Eurohospital Plovdiv OOD

Plovdiv, 4000, Bulgaria

Location

Medical Centre Artmed

Plovdiv, 4002, Bulgaria

Location

MHAT Kaspela EOOD

Plovdiv, 4002, Bulgaria

Location

UMHAT Pulmed

Plovdiv, 4002, Bulgaria

Location

University Multiprofile Hospital For Active Treatment Pulmed OOD

Plovdiv, 4002, Bulgaria

Location

Medical Centre N. I. Pirogov EOOD

Sofia, 1000, Bulgaria

Location

MHAT St Iv. Rilski

Sofia, 1612, Bulgaria

Location

UMBAL Sveti Ivan Rilski EAD

Sofia, 1612, Bulgaria

Location

Synexus Medical Center Sofia

Sofia, 1784, Bulgaria

Location

Multi-Profile District Hospital for Active Treatment Dr. Stefan Cherkezov

Veliko Tarnovo, 5000, Bulgaria

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 8140180, Japan

Location

Medical Corporation Kouhoukai Takagi Hospital

Okawa-shi, Fukuoka, 831-0016, Japan

Location

Hakodate Central General Hospital

Hakodate, Hokkaido, 040-8585, Japan

Location

Saiseikai Kanagawaken Hospital

Yokohama, Kanagawa, 221-0821, Japan

Location

Otakibashi Orthopedic Clinic

Shinjuku-ku, Tokyo, 169-0073, Japan

Location

Saitama Medical Center

Saitama, 350-8550, Japan

Location

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Location

Centrum Medyczne 4M Plus

Krakow, Malopolska, 31141, Poland

Location

ETG Warszawa

Warsaw, Masovian Voivodeship, 02-777, Poland

Location

ClinicMed Badurski I Wspolnicy Spolka Jawna

Bialystok, 15-879, Poland

Location

ClinicMed Daniluk, Nowak Spolka komandytowa

Bialystok, 15-879, Poland

Location

Zaklad Opieki Zdrowotnej w Boleslawcu

Bolesławiec, 59-700, Poland

Location

Centrum Kliniczno

Elblag, 82-300, Poland

Location

NZOZ Medi Spatz

Gliwice, 44-100, Poland

Location

PZU Zdrowie S.A. Oddzia¿ Centrum Medyczne Artimed w Kielcach

Kielce, 25-017, Poland

Location

Centrum Medyczne Semper fortis

Krakow, 31-141, Poland

Location

Centermed Krakow Sp. z o.o.

Krakow, 31-530, Poland

Location

Nzoz Centermed Krakow, Szpital I Przychodnia

Krakow, 31-530, Poland

Location

ETYKA Osrodek Badan Klinicznych

Olsztyn, 10-117, Poland

Location

Medyczne Centrum Hetmanska Indywidualna Specjalistyczna Praktyka Lekarska Dr Hab Piotr Leszczynski

Poznan, 60-218, Poland

Location

Medyczne Centrum Hetmanska

Poznan, 60-218, Poland

Location

RCMed Oddzial Sochaczew

Sochaczew, 96-500, Poland

Location

RCMed Piotr Opadczuk

Sochaczew, 96-500, Poland

Location

Lubelskie Centrum Diagnostyczne

Świdnik, 21040, Poland

Location

ETG Warszawa

Warsaw, 02-677, Poland

Location

Europejskie Centrum leczenia Chorob Cywilizacyjnych

Warsaw, 02-777, Poland

Location

ETG Warszawa

Warsaw, 02-793, Poland

Location

Wojewodzki Szpital Zespolony W Kielcach

Kielce, Świętokrzyskie Voivodeship, 25-736, Poland

Location

Spitalul Judetean Caracal

Caracal, Olt, 235200, Romania

Location

SC Medicali's SRL

Timișoara, Timiș County, 300362, Romania

Location

SC Medaudio-Optica SRL

Râmnicu Vâlcea, Vâlcea County, 240762, Romania

Location

Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL

Brasov, 500283, Romania

Location

SC Centrul Medical Sana SRL

Bucharest, 011025, Romania

Location

Spitalul Clinic Sf. Maria

Bucharest, 011172, Romania

Location

Spital Clinic Dr I Cantacuzino

Bucharest, 020475, Romania

Location

SC Policlinica CCBR SRL

Bucharest, 030463, Romania

Location

Sf. Maria Hospital

Bucharest, 11172, Romania

Location

Tread Research

Parow, Cape Town, 7500, South Africa

Location

Tygerberg hospital

Parow, Cape Town, 7500, South Africa

Location

Josha Research

Bloemfontein, Free State, 9301, South Africa

Location

Welkom Clinical Trial Centre

Welkom, Free State, 9460, South Africa

Location

Worthwhile Clinical Trials

Benoni, Gauteng, South Africa

Location

Midrand Medical Centre

Halfway House, Gauteng, 1685, South Africa

Location

Lakeview Hospital

Johannesburg, Gauteng, 1500, South Africa

Location

Global Clinical Trials

Pretoria, Gauteng, 0001, South Africa

Location

University of Pretoria

Pretoria, Gauteng, 0002, South Africa

Location

Roodepoort Medicross Clinical Research Centre

Roodepoort, Gauteng, 1724, South Africa

Location

Sandton Medical Research (Newtown CRC)

Sandton, Gauteng, 2196, South Africa

Location

Clinresco Centres (Pty) Ltd.

Kempton Park, Johannesburg, 1619, South Africa

Location

Synapta Clinical Research Center

Durban, KwaZulu-Natal, 4001, South Africa

Location

Dr Zubar Fazal Ahmed Vawda MD

Durban, KwaZulu-Natal, 4091, South Africa

Location

Precise Clinical Solutions

Durban, KwaZulu-Natal, 4092, South Africa

Location

Aliwal Shoal Medical Centre

eMkhomazi, KwaZulu-Natal, 4170, South Africa

Location

Medicross Langeberg Medical & Dental Centre

Kraaifontein, Western Cape, 7570, South Africa

Location

Medicross Langeberg Medical & Dental Centre

Kraaifontein, Western Cape, 7572, South Africa

Location

Arthritis Clinical Research Centre

Cape Town, 7405, South Africa

Location

Accellacare Yorkshire

Shipley, Yorkshire, BD18 3SA, United Kingdom

Location

Accellacare Warwickshire

Coventry, CV3 4FJ, United Kingdom

Location

Chapel Allerton Hospital - Leeds Teaching Hospitals NHS Trust

Leeds, LS7 4SA, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Grünenthal Clinical-Trials Helpdesk
• Organization: Grünenthal GmbH

clinical-trials@grunenthal.com

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Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 17, 2022
• Study Start: September 15, 2022
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: March 12, 2026
• Results First Posted: November 28, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

ZA (19); GB (3); JP (6); US (27); RO (9); BU (10); PL (22)