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

A Randomized, Double-blind, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of Intra-articular Injections of RTX-GRT7039 in Adult Subjects With Pain Associated With Osteoarthritis of the Knee

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: RTX-GRT7039; Drug: Placebo

Detailed Description

This trial comprises a total observation period of up to 52 weeks.

• Study Type: Interventional
• Enrollment (Actual): 469
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8V 4A1
      • Cook Street Medical Clinic
    • Victoria, British Columbia, Canada, V9V 4A1
      • Dr. M. B. Jones
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Aggarwal and Associates Limited
    • Mississauga, Ontario, Canada, L4V 1P1
      • Malton Medical Research
  • Quebec
    • Sainte-Foy, Quebec, Canada, G1V 3M7
      • GRMO (Groupe de Recherche en Rhumatologie et Maladies Osseuses) Inc.
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Diex Research Sherbrooke Inc.
    • Victoriaville, Quebec, Canada, G6P 6P6
      • DIEX Recherche Victoriaville Inc.
• Czechia
  • Brno, Czechia, 63800
    • Revmatologie s.r.o.
  • Břeclav, Czechia, 690 02
    • Interni A Revmatologicka Ambulance
  • Ostrava, Czechia, 702 00
    • Vesalion s.r.o.
  • Ostrava, Czechia, 70200
    • Revmatologicka ambulance
  • Prague, Czechia, 14000
    • Revmatologicka ambulance
  • Prague, Czechia, 130 00
    • CCBR Czech Prague, s.r.o
  • Prague, Czechia, 130 00
    • CCR Prague, s.r.o
  • Prague, Czechia, 140 00
    • Revmatologicka ambulance
  • Prague, Czechia, 140 00
    • Thomayerova Nemocnice (TN)
  • Prague, Czechia, 140 59
    • Fakultni Thomayerova nemocnice s poliklinikou
  • Prague, Czechia, 15000
    • EUC Klinika
  • Písek, Czechia, 397 01
    • Ortopedicko-traumatologicka ambulance
  • Příbram, Czechia, 26101
    • Db Ortopedie s.r.o
  • Zlín, Czechia, 760 01
    • PV-MEDICAL s.r.o. Revmatologicka ambulance
  • Czech Republic
    • Písek, Czech Republic, Czechia, 397 01
      • Lekarna U Svate Anny
• France
  • Amiens, France, 80054
    • CHU Amiens Nord
  • Amiens, France, 80000
    • Centre Hospitalier Universitaire d'Amiens-Picardie - Site Sud
  • Lyon, France, 69437
    • Hôpital Edouard Herriot
  • Nîmes, France, 30029
    • CHU Nimes Cedex
  • Paris, France, 75012
    • Hôpital Saint Antoine
  • Paris, France, 75014
    • Cochin Hospital-Paris Descartes University
  • Paris, France, 75014
    • Hopitaux de Paris (AP-HP) - Groupe Hospitalier Cochin -Assistance Publique
  • Paris, France, 75475
    • Hopital Lariboisiere,Hospitalier Universitaire Nord
• Germany
  • Eichstätt, Germany, 85072
    • Praxis Dr. med. Stephan Grunert
  • Essen, Germany, 45355
    • Medizentrum Essen Borbeck
  • Hamburg, Germany, 20095
    • HRF Hamburger Rheuma Forschungszentrum
  • Karlsruhe, Germany, 76133
    • Ortho-Zentrum Karlsruhe
  • Leipzig, Germany, 04103
    • Velocity Clinical Research Leipzig GmbH
  • Leipzig, Germany, 04107
    • AmBeNet, Practice Dr. Dr. med. Hans-Detlev Stahl
  • München, Germany, 80809
    • Centrum fuer Diagnostik und Gesundheit (CDG)
  • Reinfeld, Germany, 23858
    • Praxis-Reinfeld-Mitte
• Italy
  • Florence, Italy, 50134
    • AOU-Careggi
  • Florence, Italy, 50139
    • AOU-Careggi
  • Naples, Italy, 80138
    • Universita degli Studi della Campania Luigi Vanvitelli - Azienda Ospedaliera Universitaria
  • Napoli, Italy, 80138
    • Dipartimento Di Scienze Ortopediche, Traumatologiche, Riabilitative E Plastico-Ricostruttive
  • Rozzano, Italy, 20089
    • IRCCS Istituto Clinico Humanitas
  • Torino, Italy, 10126
    • AOU Citta della Salute e della Scienza di Torino
• Japan
  • Tokyo, Japan, 113-8431
    • Juntendo University Hospital
  • Tokyo, Japan, 140-0014
    • Medical Corporation Teda Ooimachi Orthopaedic Surgery and Surgery Clinic
  • Chiba
    • Funabashi-shi, Chiba, Japan, 273-8588
      • Funabashi Municipal Medical Center
    • Kamagaya, Chiba, Japan, 273-0121
      • Kamagaya General Hospital
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 810-8539
      • Hamanomachi Hospital
    • Fukuoka, Fukuoka, Japan, 813-0017
      • SOUSEIKAI Fukuoka Mirai Hospital
  • Hiroshima
    • Hiroshima, Hiroshima, Japan, 733-0032
      • Seiwa-kai medical corporation Hiroshima clinic
    • Mihara, Hiroshima, Japan, 370-0115
      • Kosei General Hospital
    • Mihara-shi, Hiroshima, Japan, 723-8686
      • Kosei General Hospital
  • Hokkaido
    • Hakodate, Hokkaido, Japan, 040-8585
      • Hakodate Central General Hospital
    • Sapporo, Hokkaido, Japan, 062-0931
      • KKR Sapporo Medical Center
    • Sapporo, Hokkaido, Japan, 0630814
      • Sapporo kotoni Orthopedies
    • Sapporo, Hokkaido, Japan, 060-0007
      • Sapporo Maruyama Orthopedic Hospital
  • Kagawa-ken
    • Takamatsu, Kagawa-ken, Japan, 761-8024
      • Kinashi Obayashi Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 222-0036
      • Yokohoma Rosai Hospital
    • Yokohama, Kanagawa, Japan, 222-0036
      • Japan Organization of Occupational Health and Safety Yokohama Rosai Hospital
  • Matsumoto-shi Nagano
    • Nagano, Matsumoto-shi Nagano, Japan, 390-8601
      • Social Medical Care Corporation Hosei-kai Marunouchi Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 983-0862
      • Nakajo Orthopedic Clinic
    • Sendai, Miyagi, Japan, 980-0803
      • KKR Tohoku Kosai Hospital
  • Nagano
    • Matsumoto, Nagano, Japan, 390-0841
      • Marunouchi Hospital
  • Sendai-shi
    • Aoba-ku, Sendai-shi, Japan, 980-0803
      • KKR Tohoku Kosai Hospital
  • Shiga
    • Ōtsu, Shiga, Japan, 520-0804
      • Otsu City Hospital
  • Shimane
    • Izumo, Shimane, Japan, 693-8501
      • Shimane University Hospital
    • Izumo, Shimane, Japan, 693-0021
      • Shimane University Hospital
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 434-8533
      • Japanese Red Cross Hamamatsu Hospital
  • Tokyo
    • Bunkyo-Ku, Tokyo, Japan, 113-0033
      • Juntendo University Hospital
    • Bunkyo-ku, Tokyo, Japan, 113-0034
      • Juntendo University Graduate School of Medicine
    • Minato-ku, Tokyo, Japan, 108-8642
      • Kitasato University Kitasato Institute Hospital
  • Wakayama
    • Nishimura, Wakayama, Japan, 649-2211
      • Shirahama Hamayu Hospital
• Mexico
  • Chihuahua City, Mexico, 31000
    • Investigacion y Biomedicina de Chihuahua
  • Guanajuato
    • León, Guanajuato, Mexico, 37000
      • Morales Vargas Centro de Investigacion SC
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44160
      • Centro Integral en Reumatologia, SA de CV
  • Mexico City
    • Cuauhtémoc, Mexico City, Mexico, 06700
      • Clinstile, S.A. de C.V
    • Gustavo Adolfo Madero, Mexico City, Mexico, 07760
      • Consultorio de Reumatologia
    • Mexico City, Mexico City, Mexico, 11850
      • CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62448
      • Dr. Miguel Cortes Hernandez MD, Office of
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80000
      • Centro de Investigacion de Tratamientos Innovadores de Sinaloa S.C.
• Netherlands
  • Hoofddorp, Netherlands, 2134 TM
    • Spaarne Gasthuis (Kennemer Gasthuis)
  • KZ
    • Enschede, KZ, Netherlands, 7512 KZ
      • Medisch Spectrum Twente (MST) - Enschede Haaksbergerstraat
  • Limburg
    • Beek, Limburg, Netherlands, 6191 JW
      • PT&R
• Poland
  • Bialystok, Poland, 15-077
    • INTER CLINIC Piotr Adrian Klimiuk
  • Gdynia, Poland, 81-537
    • Synexus Gdynia
  • Grodzisk Mazowiecki, Poland, 05-825
    • Mazowieckie Centrum Badan Klinicznych
  • Katowice, Poland, 40-081
    • Centrum Medyczne Pratia Katowice
  • Katowice, Poland, 40-040
    • Synexus Katowice Medical Center
  • Krakow, Poland, 30-149
    • Malopolskie Centrum Kliniczne
  • Krakow, Poland, 30-363
    • St Centrum Medyczne Plejady
  • Lodz, Poland, 90-127
    • Synexus Polska Sp. z o.o. Oddzial w Lodzi
  • Lublin, Poland, 20-362
    • KO-MED Centra Kliniczne Lublin II
  • Wroclaw, Poland, 50-381
    • Synexus Polska Spolka z ograniczona odpowiedzialnoscia Oddzial we Wroclawiu
  • Zamość, Poland, 22400
    • Centrum Medyczne Kuba-Med Zamosc
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-702
      • Synexus Poznan Medical Center
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-727
      • Pratia MCM Krakow
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-607
      • Reumed Spolka z o.o. Zespol poradni Specjalistycznych Filia Nr 1 Wallenroda
    • Zamość, Lublin Voivodeship, Poland, 20-362
      • KO-MED Centra Kliniczne Lublin II
  • Masovian Voivodeship
    • Nadarzyn, Masovian Voivodeship, Poland, 05-830
      • Makmed Nzoz
    • Nadarzyn, Masovian Voivodeship, Poland, 05-830
      • NZOZ Lecznica MAK-MED S.C.
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-077
      • Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-382
      • Synexus Polska Sp. z o.o. Oddzial w Gdansku

Participation Criteria

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RTX-GRT7039; Participants will receive intra-articular injections of RTX-GRT7039 during the 52-week double-blind treatment period.	Drug: RTX-GRT7039; RTX-GRT7039 intra-articular injection.
Placebo Comparator: Placebo; Participants will receive intra-articular injections of placebo matching to RTX-GRT7039 during the 52-week double-blind treatment period.	Drug: Placebo; Placebo matching RTX-GRT7039 intra-articular injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Least Squares Mean (Standard Error) [LS-mean (SE)] Change From Baseline in WOMAC Pain Subscale Score at Week 12	Difference in mean change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score at Week 12 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.	Baseline up to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 26	Difference in mean change from baseline in WOMAC pain subscale score at Week 26 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.	From Baseline up to Week 26
LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 52	Difference in mean change from baseline in WOMAC pain subscale score at Week 52 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.	From Baseline up to Week 52
LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 12	Difference in mean change from baseline in WOMAC physical function subscale score at Week 12 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.	From Baseline up to Week 12
LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 26	Difference in mean change from baseline in WOMAC physical function subscale score at Week 26 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.	From Baseline up to Week 26
LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 52	Difference in mean change from baseline in WOMAC physical function subscale score at Week 26 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.	From Baseline up to Week 52

Collaborators and Investigators

• Sponsor: Grünenthal GmbH

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2022
• Primary Completion (Actual): November 18, 2024
• Study Completion (Actual): November 18, 2024

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: osteoarthritis; pain assessment; Knee,
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: KF7039-01; 2021-005029-26 (EudraCT Number); U1111-1268-7314 (Other Identifier: Universal Trial Number)

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