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

NCT ID: NCT05248386

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 469 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-26
• Study Completion Date: 2024-11-18

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

RTX-GRT7039

Participants will receive intra-articular injections of RTX-GRT7039 during the 52-week double-blind treatment period.

Group Type: EXPERIMENTAL

RTX-GRT7039

Intervention Type: DRUG

RTX-GRT7039 intra-articular injection.

Placebo

Participants will receive intra-articular injections of placebo matching to RTX-GRT7039 during the 52-week double-blind treatment period.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo matching RTX-GRT7039 intra-articular injection.

Interventions

RTX-GRT7039

RTX-GRT7039 intra-articular injection.

Intervention Type: DRUG

Placebo

Placebo matching RTX-GRT7039 intra-articular injection.

Intervention Type: DRUG

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 from any cause other than osteoarthritis, including referred pain, bursitis, or tendonitis.
• The participant has clinical hip osteoarthritis on the side of the index knee.
• The participant has pre-existing osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, severe bone on bone osteoarthritis, knee pain attributable to disease other than osteoarthritis, or the participant has rapidly progressing osteoarthritis (RPOA) Type I or Type II.
• 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 X-ray 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 efficacy or safety assessments, or any other reason which, in the investigator's opinion, 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grünenthal GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cook Street Medical Clinic

Victoria, British Columbia, Canada

Dr. M. B. Jones

Victoria, British Columbia, Canada

Aggarwal and Associates Limited

Brampton, Ontario, Canada

Malton Medical Research

Mississauga, Ontario, Canada

GRMO (Groupe de Recherche en Rhumatologie et Maladies Osseuses) Inc.

Sainte-Foy, Quebec, Canada

Diex Research Sherbrooke Inc.

Sherbrooke, Quebec, Canada

Diex Recherche Victoriaville Inc.

Victoriaville, Quebec, Canada

Lekarna U Svate Anny

Písek, Czech Republic, Czechia

Revmatologie s.r.o.

Brno, , Czechia

Interni A Revmatologicka Ambulance

Břeclav, , Czechia

Vesalion s.r.o.

Ostrava, , Czechia

Revmatologicka Ambulance

Ostrava, , Czechia

Ortopedicko-traumatologicka ambulance

Písek, , Czechia

CCBR Czech Prague, s.r.o

Prague, , Czechia

CCR Prague, s.r.o

Prague, , Czechia

Revmatologicka ambulance

Prague, , Czechia

Thomayerova Nemocnice (TN)

Prague, , Czechia

Fakultni Thomayerova nemocnice s poliklinikou

Prague, , Czechia

Revmatologicka ambulance

Prague, , Czechia

EUC Klinika

Prague, , Czechia

Db Ortopedie s.r.o

Příbram, , Czechia

PV-MEDICAL s.r.o. Revmatologicka ambulance

Zlín, , Czechia

Centre Hospitalier Universitaire d'Amiens-Picardie - Site Sud

Amiens, , France

CHU Amiens Nord

Amiens, , France

Hopital Edouard Herriot

Lyon, , France

CHU Nimes Cedex

Nîmes, , France

Hopital Saint antoine

Paris, , France

Cochin Hospital-Paris Descartes University

Paris, , France

Hopitaux de Paris (AP-HP) - Groupe Hospitalier Cochin -Assistance Publique

Paris, , France

Hopital Lariboisiere,Hospitalier Universitaire Nord

Paris, , France

Praxis Dr. med. Stephan Grunert

Eichstätt, , Germany

Medizentrum Essen Borbeck

Essen, , Germany

HRF Hamburger Rheuma Forschungszentrum

Hamburg, , Germany

Ortho-Zentrum Karlsruhe

Karlsruhe, , Germany

Velocity Clinical Research Leipzig GmbH

Leipzig, , Germany

AmBeNet, Practice Dr. Dr. med. Hans-Detlev Stahl

Leipzig, , Germany

Centrum fuer Diagnostik und Gesundheit (CDG)

München, , Germany

Praxis-Reinfeld-Mitte

Reinfeld, , Germany

AOU-Careggi

Florence, , Italy

AOU-Careggi

Florence, , Italy

Universita degli Studi della Campania Luigi Vanvitelli - Azienda Ospedaliera Universitaria

Naples, , Italy

Dipartimento Di Scienze Ortopediche, Traumatologiche, Riabilitative E Plastico-Ricostruttive

Napoli, , Italy

IRCCS Istituto Clinico Humanitas

Rozzano, , Italy

AOU Citta della Salute e della Scienza di Torino

Torino, , Italy

Funabashi Municipal Medical Center

Funabashi-shi, Chiba, Japan

Kamagaya General Hospital

Kamagaya, Chiba, Japan

Hamanomachi Hospital

Fukuoka, Fukuoka, Japan

Souseikai Fukuoka Mirai Hospital

Fukuoka, Fukuoka, Japan

Seiwa-kai medical corporation Hiroshima clinic

Hiroshima, Hiroshima, Japan

Kosei General Hospital

Mihara, Hiroshima, Japan

Kosei General Hospital

Mihara-shi, Hiroshima, Japan

Hakodate Central General Hospital

Hakodate, Hokkaido, Japan

Sapporo Maruyama Orthopedic Hospital

Sapporo, Hokkaido, Japan

KKR Sapporo Medical Center

Sapporo, Hokkaido, Japan

Sapporo kotoni Orthopedies

Sapporo, Hokkaido, Japan

Kinashi Obayashi Hospital

Takamatsu, Kagawa-ken, Japan

Japan Organization of Occupational Health and Safety Yokohama Rosai Hospital

Yokohama, Kanagawa, Japan

Yokohoma Rosai Hospital

Yokohama, Kanagawa, Japan

Social Medical Care Corporation Hosei-kai Marunouchi Hospital

Nagano, Matsumoto-shi Nagano, Japan

KKR Tohoku Kosai Hospital

Sendai, Miyagi, Japan

Nakajo Orthopedic Clinic

Sendai, Miyagi, Japan

Marunouchi Hospital

Matsumoto, Nagano, Japan

KKR Tohoku Kosai Hospital

Aoba-ku, Sendai-shi, Japan

Otsu City Hospital

Ōtsu, Shiga, Japan

Shimane University Hospital

Izumo, Shimane, Japan

Shimane University Hospital

Izumo, Shimane, Japan

Japanese Red Cross Hamamatsu Hospital

Hamamatsu, Shizuoka, Japan

Juntendo University Hospital

Bunkyo-Ku, Tokyo, Japan

Juntendo University Graduate School of Medicine

Bunkyo-ku, Tokyo, Japan

Kitasato University Kitasato Institute Hospital

Minato-ku, Tokyo, Japan

Shirahama Hamayu Hospital

Nishimura, Wakayama, Japan

Juntendo University Hospital

Tokyo, , Japan

Medical Corporation Teda Ooimachi Orthopaedic Surgery and Surgery Clinic

Tokyo, , Japan

Morales Vargas Centro de Investigacion SC

León, Guanajuato, Mexico

Centro Integral en Reumatologia, SA de CV

Guadalajara, Jalisco, Mexico

Clinstile, S.A. de C.V

Cuauhtémoc, Mexico City, Mexico

Consultorio de Reumatologia

Gustavo Adolfo Madero, Mexico City, Mexico

CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.

Mexico City, Mexico City, Mexico

Dr. Miguel Cortes Hernandez MD, Office of

Cuernavaca, Morelos, Mexico

Centro de Investigacion de Tratamientos Innovadores de Sinaloa S.C.

Culiacán, Sinaloa, Mexico

Investigacion y Biomedicina de Chihuahua

Chihuahua City, , Mexico

Medisch Spectrum Twente (MST) - Enschede Haaksbergerstraat

Enschede, KZ, Netherlands

PT&R

Beek, Limburg, Netherlands

Spaarne Gasthuis (Kennemer Gasthuis)

Hoofddorp, , Netherlands

Synexus Poznan Medical Center

Poznan, Greater Poland Voivodeship, Poland

Pratia MCM Krakow

Krakow, Lesser Poland Voivodeship, Poland

Reumed Spolka z o.o. Zespol poradni Specjalistycznych Filia Nr 1 Wallenroda

Lublin, Lublin Voivodeship, Poland

KO-MED Centra Kliniczne Lublin II

Zamość, Lublin Voivodeship, Poland

Makmed Nzoz

Nadarzyn, Masovian Voivodeship, Poland

NZOZ Lecznica MAK-MED S.C.

Nadarzyn, Masovian Voivodeship, Poland

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

Bialystok, Podlaskie Voivodeship, Poland

Synexus Polska Sp. z o.o. Oddzial w Gdansku

Gdansk, Pomeranian Voivodeship, Poland

INTER CLINIC Piotr Adrian Klimiuk

Bialystok, , Poland

Synexus Gdynia

Gdynia, , Poland

Mazowieckie Centrum Badan Klinicznych

Grodzisk Mazowiecki, , Poland

Synexus Katowice Medical Center

Katowice, , Poland

Centrum Medyczne Pratia Katowice

Katowice, , Poland

Malopolskie Centrum Kliniczne

Krakow, , Poland

St Centrum Medyczne Plejady

Krakow, , Poland

Synexus Polska Sp. z o.o. Oddzial w Lodzi

Lodz, , Poland

KO-MED Centra Kliniczne Lublin II

Lublin, , Poland

Synexus Polska Spolka z ograniczona odpowiedzialnoscia Oddzial we Wroclawiu

Wroclaw, , Poland

Centrum Medyczne Kuba-Med Zamosc

Zamość, , Poland

Countries

Canada; Czechia; France; Germany; Italy; Japan; Mexico; Netherlands; Poland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2021-005029-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1268-7314

Identifier Type: OTHER

Identifier Source: secondary_id

KF7039-01

Identifier Type: -

Identifier Source: org_study_id