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

NCT05248386 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: KF7039-012021-005029-26U1111-1268-7314
• Study Type: interventional
• Target: 469
• Locations: 9 countries
• Sites: 103

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.

Conditions

Osteoarthritis

Keywords

Knee,; osteoarthritis; pain assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 26

  From Baseline up to Week 26

• LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 52

  From Baseline up to Week 52

• LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 12

  From Baseline up to Week 12

• LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 26

  From Baseline up to Week 26

• LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 52

  From Baseline up to Week 52

Study Arms (2)

RTX-GRT7039

EXPERIMENTAL

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

Drug: RTX-GRT7039

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

RTX-GRT7039 DRUG

RTX-GRT7039 intra-articular injection.

RTX-GRT7039

Placebo DRUG

Placebo matching RTX-GRT7039 intra-articular injection.

Placebo

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 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.

Sponsors & Collaborators

• Grünenthal GmbH: lead

Study Sites (103)

Cook Street Medical Clinic

Victoria, British Columbia, V8V 4A1, Canada

Location

Dr. M. B. Jones

Victoria, British Columbia, V9V 4A1, Canada

Location

Aggarwal and Associates Limited

Brampton, Ontario, L6T 0G1, Canada

Location

Malton Medical Research

Mississauga, Ontario, L4V 1P1, Canada

Location

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

Sainte-Foy, Quebec, G1V 3M7, Canada

Location

Diex Research Sherbrooke Inc.

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Diex Recherche Victoriaville Inc.

Victoriaville, Quebec, G6P 6P6, Canada

Location

Lekarna U Svate Anny

Písek, Czech Republic, 397 01, Czechia

Location

Revmatologie s.r.o.

Brno, 63800, Czechia

Location

Interni A Revmatologicka Ambulance

Břeclav, 690 02, Czechia

Location

Vesalion s.r.o.

Ostrava, 702 00, Czechia

Location

Revmatologicka Ambulance

Ostrava, 70200, Czechia

Location

Ortopedicko-traumatologicka ambulance

Písek, 397 01, Czechia

Location

CCBR Czech Prague, s.r.o

Prague, 130 00, Czechia

Location

CCR Prague, s.r.o

Prague, 130 00, Czechia

Location

Revmatologicka ambulance

Prague, 140 00, Czechia

Location

Thomayerova Nemocnice (TN)

Prague, 140 00, Czechia

Location

Fakultni Thomayerova nemocnice s poliklinikou

Prague, 140 59, Czechia

Location

Revmatologicka ambulance

Prague, 14000, Czechia

Location

EUC Klinika

Prague, 15000, Czechia

Location

Db Ortopedie s.r.o

Příbram, 26101, Czechia

Location

PV-MEDICAL s.r.o. Revmatologicka ambulance

Zlín, 760 01, Czechia

Location

Centre Hospitalier Universitaire d'Amiens-Picardie - Site Sud

Amiens, 80000, France

Location

CHU Amiens Nord

Amiens, 80054, France

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

CHU Nimes Cedex

Nîmes, 30029, France

Location

Hopital Saint antoine

Paris, 75012, France

Location

Cochin Hospital-Paris Descartes University

Paris, 75014, France

Location

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

Paris, 75014, France

Location

Hopital Lariboisiere,Hospitalier Universitaire Nord

Paris, 75475, France

Location

Praxis Dr. med. Stephan Grunert

Eichstätt, 85072, Germany

Location

Medizentrum Essen Borbeck

Essen, 45355, Germany

Location

HRF Hamburger Rheuma Forschungszentrum

Hamburg, 20095, Germany

Location

Ortho-Zentrum Karlsruhe

Karlsruhe, 76133, Germany

Location

Velocity Clinical Research Leipzig GmbH

Leipzig, 04103, Germany

Location

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

Leipzig, 04107, Germany

Location

Centrum fuer Diagnostik und Gesundheit (CDG)

München, 80809, Germany

Location

Praxis-Reinfeld-Mitte

Reinfeld, 23858, Germany

Location

AOU-Careggi

Florence, 50134, Italy

Location

AOU-Careggi

Florence, 50139, Italy

Location

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

Naples, 80138, Italy

Location

Universita degli Studi della Campania Luigi Vanvitelli - Azienda Ospedaliera Universitaria

Naples, 80138, Italy

Location

IRCCS Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

AOU Citta della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Funabashi Municipal Medical Center

Funabashi-shi, Chiba, 273-8588, Japan

Location

Kamagaya General Hospital

Kamagaya, Chiba, 273-0121, Japan

Location

Hamanomachi Hospital

Fukuoka, Fukuoka, 810-8539, Japan

Location

Souseikai Fukuoka Mirai Hospital

Fukuoka, Fukuoka, 813-0017, Japan

Location

Seiwa-kai medical corporation Hiroshima clinic

Hiroshima, Hiroshima, 733-0032, Japan

Location

Kosei General Hospital

Mihara, Hiroshima, 370-0115, Japan

Location

Kosei General Hospital

Mihara-shi, Hiroshima, 723-8686, Japan

Location

Hakodate Central General Hospital

Hakodate, Hokkaido, 040-8585, Japan

Location

Sapporo Maruyama Orthopedic Hospital

Sapporo, Hokkaido, 060-0007, Japan

Location

KKR Sapporo Medical Center

Sapporo, Hokkaido, 062-0931, Japan

Location

Sapporo kotoni Orthopedies

Sapporo, Hokkaido, 0630814, Japan

Location

Kinashi Obayashi Hospital

Takamatsu, Kagawa-ken, 761-8024, Japan

Location

Japan Organization of Occupational Health and Safety Yokohama Rosai Hospital

Yokohama, Kanagawa, 222-0036, Japan

Location

Yokohoma Rosai Hospital

Yokohama, Kanagawa, 222-0036, Japan

Location

Social Medical Care Corporation Hosei-kai Marunouchi Hospital

Nagano, Matsumoto-shi Nagano, 390-8601, Japan

Location

KKR Tohoku Kosai Hospital

Sendai, Miyagi, 980-0803, Japan

Location

Nakajo Orthopedic Clinic

Sendai, Miyagi, 983-0862, Japan

Location

Marunouchi Hospital

Matsumoto, Nagano, 390-0841, Japan

Location

KKR Tohoku Kosai Hospital

Aoba-ku, Sendai-shi, 980-0803, Japan

Location

Otsu City Hospital

Ōtsu, Shiga, 520-0804, Japan

Location

Shimane University Hospital

Izumo, Shimane, 693-0021, Japan

Location

Shimane University Hospital

Izumo, Shimane, 693-8501, Japan

Location

Japanese Red Cross Hamamatsu Hospital

Hamamatsu, Shizuoka, 434-8533, Japan

Location

Juntendo University Hospital

Bunkyo-Ku, Tokyo, 113-0033, Japan

Location

Juntendo University Graduate School of Medicine

Bunkyo-ku, Tokyo, 113-0034, Japan

Location

Kitasato University Kitasato Institute Hospital

Minato-ku, Tokyo, 108-8642, Japan

Location

Shirahama Hamayu Hospital

Nishimura, Wakayama, 649-2211, Japan

Location

Juntendo University Hospital

Tokyo, 113-8431, Japan

Location

Medical Corporation Teda Ooimachi Orthopaedic Surgery and Surgery Clinic

Tokyo, 140-0014, Japan

Location

Morales Vargas Centro de Investigacion SC

León, Guanajuato, 37000, Mexico

Location

Centro Integral en Reumatologia, SA de CV

Guadalajara, Jalisco, 44160, Mexico

Location

Clinstile, S.A. de C.V

Cuauhtémoc, Mexico City, 06700, Mexico

Location

Consultorio de Reumatologia

Gustavo Adolfo Madero, Mexico City, 07760, Mexico

Location

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

Mexico City, Mexico City, 11850, Mexico

Location

Dr. Miguel Cortes Hernandez MD, Office of

Cuernavaca, Morelos, 62448, Mexico

Location

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

Culiacán, Sinaloa, 80000, Mexico

Location

Investigacion y Biomedicina de Chihuahua

Chihuahua City, 31000, Mexico

Location

Medisch Spectrum Twente (MST) - Enschede Haaksbergerstraat

Enschede, KZ, 7512 KZ, Netherlands

Location

PT&R

Beek, Limburg, 6191 JW, Netherlands

Location

Spaarne Gasthuis (Kennemer Gasthuis)

Hoofddorp, 2134 TM, Netherlands

Location

Synexus Poznan Medical Center

Poznan, Greater Poland Voivodeship, 60-702, Poland

Location

Pratia MCM Krakow

Krakow, Lesser Poland Voivodeship, 30-727, Poland

Location

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

Lublin, Lublin Voivodeship, 20-607, Poland

Location

KO-MED Centra Kliniczne Lublin II

Zamość, Lublin Voivodeship, 20-362, Poland

Location

Makmed Nzoz

Nadarzyn, Masovian Voivodeship, 05-830, Poland

Location

NZOZ Lecznica MAK-MED S.C.

Nadarzyn, Masovian Voivodeship, 05-830, Poland

Location

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

Bialystok, Podlaskie Voivodeship, 15-077, Poland

Location

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

Gdansk, Pomeranian Voivodeship, 80-382, Poland

Location

INTER CLINIC Piotr Adrian Klimiuk

Bialystok, 15-077, Poland

Location

Synexus Gdynia

Gdynia, 81-537, Poland

Location

Mazowieckie Centrum Badan Klinicznych

Grodzisk Mazowiecki, 05-825, Poland

Location

Synexus Katowice Medical Center

Katowice, 40-040, Poland

Location

Centrum Medyczne Pratia Katowice

Katowice, 40-081, Poland

Location

Malopolskie Centrum Kliniczne

Krakow, 30-149, Poland

Location

St Centrum Medyczne Plejady

Krakow, 30-363, Poland

Location

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

Lodz, 90-127, Poland

Location

KO-MED Centra Kliniczne Lublin II

Lublin, 20-362, Poland

Location

Synexus Polska Spolka z ograniczona odpowiedzialnoscia Oddzial we Wroclawiu

Wroclaw, 50-381, Poland

Location

Centrum Medyczne Kuba-Med Zamosc

Zamość, 22400, Poland

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 21, 2022
• Study Start: August 26, 2022
• Primary Completion: November 18, 2024
• Study Completion: November 18, 2024
• Last Updated: March 18, 2026
• Results First Posted: August 12, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

IT (6); FR (8); CZ (15); DE (8); PL (19); CA (7); NL (3); ME (8); JP (29)