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OsteoarthritisPhase 3NCT05377489

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

A Phase 3 study testing RTX-GRT7039 in people with Osteoarthritis, run by Grünenthal GmbH at 96 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis
What is being tested?
RTX-GRT7039
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
714 participants
Where
96 sitesin 7 countries
Study dates
15 Sep 2022to 15 May 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

96 sites in 7 countries.

96 sites in 7 countries

United States27 sites

  • Orange County Research Institute

    Anaheim, California, 92801

  • Injury Care Research

    Boise, Idaho, 83713

  • Chicago Clinical Research Institute Inc.

    Chicago, Illinois, 60607

  • M3-Emerging Medical Research, LLC

    Durham, North Carolina, 27704

  • Arizona Arthritis and Rheumatology Associates (AARA) P.C

    Glendale, Arizona, 85306

  • OrthoIndy, Inc.

    Greenwood, Indiana, 46143

  • Drug Trials America

    Hartsdale, New York, 10530

  • University Of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Accellacare-Knoxville

    Knoxville, Tennessee, 37912

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Las Vegas Clinical Trials, LLC

    North Las Vegas, Nevada, 89030

  • Neuroscience Research Center, LLC

    Overland Park, Kansas, 66210

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • M3-Emerging Medical Research, LLC

    Raleigh, North Carolina, 27704

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • Tekton Research, Inc.

    San Antonio, Texas, 78229

  • Acclaim Clinical Research, Inc.

    San Diego, California, 92120

  • Gulfcoast Research Institute

    Sarasota, Florida, 34232

  • University Orthopedics Center

    State College, Pennsylvania, 16801

  • Westlake Medical Research

    Thousand Oaks, California, 91360

  • Oakland Medical Research Center

    Troy, Michigan, 48085

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01605

Other trials in United States

Poland22 sites

  • ClinicMed Badurski I Wspolnicy Spolka Jawna

    Bialystok, 15-879

  • ClinicMed Daniluk, Nowak Spolka komandytowa

    Bialystok, 15-879

  • Zaklad Opieki Zdrowotnej w Boleslawcu

    Bolesławiec, 59-700

  • Centrum Kliniczno

    Elblag, 82-300

  • NZOZ Medi Spatz

    Gliwice, 44-100

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

    Kielce, 25-017

  • Wojewodzki Szpital Zespolony W Kielcach

    Kielce, Świętokrzyskie Voivodeship, 25-736

  • Centrum Medyczne 4M Plus

    Krakow, Malopolska, 31141

  • Centrum Medyczne Semper fortis

    Krakow, 31-141

  • Centermed Krakow Sp. z o.o.

    Krakow, 31-530

  • Nzoz Centermed Krakow, Szpital I Przychodnia

    Krakow, 31-530

  • ETYKA Osrodek Badan Klinicznych

    Olsztyn, 10-117

  • Medyczne Centrum Hetmanska Indywidualna Specjalistyczna Praktyka Lekarska Dr Hab Piotr Leszczynski

    Poznan, 60-218

  • Medyczne Centrum Hetmanska

    Poznan, 60-218

  • RCMed Oddzial Sochaczew

    Sochaczew, 96-500

  • RCMed Piotr Opadczuk

    Sochaczew, 96-500

  • Lubelskie Centrum Diagnostyczne

    Świdnik, 21040

  • ETG Warszawa

    Warsaw, Masovian Voivodeship, 02-777

  • ETG Warszawa

    Warsaw, 02-677

  • Europejskie Centrum leczenia Chorob Cywilizacyjnych

    Warsaw, 02-777

  • ETG Warszawa

    Warsaw, 02-793

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, Lower Silesian Voivodeship, 50-556

Other trials in Poland

South Africa19 sites

  • Worthwhile Clinical Trials

    Benoni, Gauteng

  • Josha Research

    Bloemfontein, Free State, 9301

  • Arthritis Clinical Research Centre

    Cape Town, 7405

  • Synapta Clinical Research Center

    Durban, KwaZulu-Natal, 4001

  • Dr Zubar Fazal Ahmed Vawda MD

    Durban, KwaZulu-Natal, 4091

  • Precise Clinical Solutions

    Durban, KwaZulu-Natal, 4092

  • Aliwal Shoal Medical Centre

    eMkhomazi, KwaZulu-Natal, 4170

  • Midrand Medical Centre

    Halfway House, Gauteng, 1685

  • Lakeview Hospital

    Johannesburg, Gauteng, 1500

  • Clinresco Centres (Pty) Ltd.

    Kempton Park, Johannesburg, 1619

  • Medicross Langeberg Medical & Dental Centre

    Kraaifontein, Western Cape, 7570

  • Medicross Langeberg Medical & Dental Centre

    Kraaifontein, Western Cape, 7572

  • Tread Research

    Parow, Cape Town, 7500

  • Tygerberg hospital

    Parow, Cape Town, 7500

  • Global Clinical Trials

    Pretoria, Gauteng, 0001

  • University of Pretoria

    Pretoria, Gauteng, 0002

  • Roodepoort Medicross Clinical Research Centre

    Roodepoort, Gauteng, 1724

  • Sandton Medical Research (Newtown CRC)

    Sandton, Gauteng, 2196

  • Welkom Clinical Trial Centre

    Welkom, Free State, 9460

Other trials in South Africa

Bulgaria10 sites

  • UMHAT Eurohospital Plovdiv OOD

    Plovdiv, 4000

  • Medical Centre Artmed

    Plovdiv, 4002

  • MHAT Kaspela EOOD

    Plovdiv, 4002

  • UMHAT Pulmed

    Plovdiv, 4002

  • University Multiprofile Hospital For Active Treatment Pulmed OOD

    Plovdiv, 4002

  • Medical Centre N. I. Pirogov EOOD

    Sofia, 1000

  • MHAT St Iv. Rilski

    Sofia, 1612

  • UMBAL Sveti Ivan Rilski EAD

    Sofia, 1612

  • Synexus Medical Center Sofia

    Sofia, 1784

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

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Romania9 sites

  • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL

    Brasov, 500283

  • SC Centrul Medical Sana SRL

    Bucharest, 011025

  • Spitalul Clinic Sf. Maria

    Bucharest, 011172

  • Spital Clinic Dr I Cantacuzino

    Bucharest, 020475

  • SC Policlinica CCBR SRL

    Bucharest, 030463

  • Sf. Maria Hospital

    Bucharest, 11172

  • Spitalul Judetean Caracal

    Caracal, Olt, 235200

  • SC Medaudio-Optica SRL

    Râmnicu Vâlcea, Vâlcea County, 240762

  • SC Medicali's SRL

    Timișoara, Timiș County, 300362

Other trials in Romania

Japan6 sites

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 8140180

  • Hakodate Central General Hospital

    Hakodate, Hokkaido, 040-8585

  • Medical Corporation Kouhoukai Takagi Hospital

    Okawa-shi, Fukuoka, 831-0016

  • Saitama Medical Center

    Saitama, 350-8550

  • Otakibashi Orthopedic Clinic

    Shinjuku-ku, Tokyo, 169-0073

  • Saiseikai Kanagawaken Hospital

    Yokohama, Kanagawa, 221-0821

Other trials in Japan

United Kingdom3 sites

  • Accellacare Warwickshire

    Coventry, CV3 4FJ

  • Chapel Allerton Hospital - Leeds Teaching Hospitals NHS Trust

    Leeds, LS7 4SA

  • Accellacare Yorkshire

    Shipley, Yorkshire, BD18 3SA

Other trials in United Kingdom

About this study

Official title: 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.

Read the detailed description

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

Conditions
Osteoarthritis
Being tested
RTX-GRT7039
Keywords
Knee, Osteoarthritis, Pain assessment
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RTX-GRT7039Drug

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

Study groups in NCT05377489
Study groupRoleWhat they receive
RTX-GRT7039ExperimentalParticipants 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.
Receives: Drug: RTX-GRT7039

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: From Baseline up to Week 78

  2. Number of Participants With TEAEs Leading to Study Discontinuation

    Measured: From Baseline up to Week 78

Secondary outcomes (2)

  1. Number of Participants With TEAEs Representing Structural Changes as Assessed by Imaging Methods

    Measured: From Baseline up to Week 78

  2. Change From Baseline in WOMAC Pain Subscale Score

    The WOMAC pain subscale will be assessed using an 11-point numerical rating scale (NRS), where 0= no pain and 10=worst pain.

    Measured: From Baseline up to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2022
  2. Study start15 Sep 2022
  3. Primary completion15 May 2025
  4. Study completion15 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
714 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05377489
Sponsor's protocol ID
KF7039-03
Other IDs
2021-005046-15, U1111-1268-7230, 2024-515709-24-00
Status last verified
Feb 2026
First submitted
12 May 2022
Last updated
12 Mar 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RTX-GRT7039 in people with Osteoarthritis, run by Grünenthal GmbH at 96 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States, Poland, South Africa, Bulgaria, Romania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: From Baseline up to Week 78). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05377489.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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