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

Osteoarthritis Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05377489
• Other study ID #: KF7039-03
• Secondary ID: 2021-005046-15U1
• Status: Recruiting
• Phase: Phase 3
• Start date: August 26, 2022
• Est. completion date: August 2024

Study information

• Verified date: September 2023
• Source: Grünenthal GmbH
• Contact: Director clinical trials
• Phone: +49 241 569
• Email: clinical-trials[@]grunenthal.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 930
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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. 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• RTX-GRT7039
RTX-GRT7039 monoarticular injections or bilateral intra-articular injections.

Locations

Country	Name	City	State
Bulgaria	Medical Centre Artmed	Plovdiv
Bulgaria	UMHAT Eurohospital Plovdiv OOD	Plovdiv
Bulgaria	UMHAT Pulmed	Plovdiv
Bulgaria	Medical Centre N. I. Pirogov EOOD	Sofia
Bulgaria	MHAT St Iv. Rilski	Sofia
Bulgaria	Synexus Medical Center Sofia	Sofia
Japan	Fukuoka University Hospital	Fukuoka-shi	Fukuoka
Japan	Hakodate Central General Hospital	Hakodate	Hokkaido
Japan	Kitakyushu General Hospital	Kitakyushu-city	Fukuoka
Japan	Medical Corporation Kouhoukai Takagi Hospital	Okawa-shi	Fukuoka
Japan	Saitama Medical Center	Saitama
Japan	Otakibashi Orthopedic Clinic	Shinjuku-ku	Tokyo
Japan	Saiseikai Kanagawaken Hospital	Yokohama-shi	Kanagawa
Poland	ClinicMed Daniluk, Nowak Spolka komandytowa	Bialystok
Poland	Zaklad Opieki Zdrowotnej w Boleslawcu	Boleslawiec
Poland	Centrum Kliniczno	Elblag
Poland	NZOZ Medi Spatz	Gliwice
Poland	Medyczne Centrum Hetmanska	Hetmanska
Poland	Centrum Medyczne Novumed	Jablonna	Mazowieckie
Poland	PZU Zdrowie S.A. Oddzia¿ Centrum Medyczne Artimed w Kielcach	Kielce
Poland	Centermed Krakow Sp. z o.o.	Krakow
Poland	Centrum Medyczne Semper fortis	Krakow
Poland	ETYKA Osrodek Badan Klinicznych	Olsztyn
Poland	RCMed Piotr Opadczuk	Sochaczew
Poland	Lubelskie Centrum Diagnostyczne	Swidnik
Poland	ETG Warszawa	Warszawa
Poland	Europejskie Centrum leczenia Chorob Cywilizacyjnych	Warszawa
Romania	Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL	Brasov
Romania	SC Policlinica CCBR SRL	Bucharest
Romania	Spital Clinic Dr I Cantacuzino	Bucharest
Romania	SC Centrul Medical Sana SRL	Bucuresti
Romania	Spitalul Clinic Sf. Maria	Bucuresti
Romania	Spitalul Judetean Caracal	Caracal	Olt
Romania	SC Medaudio-Optica SRL	Râmnicu Vâlcea	Valcea
Romania	SC Medicali's SRL	Timisoara	Timis
South Africa	Worthwhile Clinical Trials	Benoni	Gauteng
South Africa	Josha Research	Bloemfontein	Free State
South Africa	Arthritis Clinical Research Centre	Cape Town
South Africa	Dr Zubar Fazal Ahmed Vawda MD	Durban	Kwa Zulu Natal
South Africa	Precise Clinical Solutions	Durban	Kwa-Zulu Natal
South Africa	Synapta Clinical Research Center	Durban	Kwa-Zulu Natal
South Africa	Midrand Medical Centre	Halfway House	Gauteng
South Africa	Clinresco Centres (Pty) Ltd.	Kempton Park	Johannesburg
South Africa	Medicross Langeberg Medical & Dental Centre	Kraaifontein	Western Cape
South Africa	Tread Research	Parow	Cape Town
South Africa	Global Clinical Trials	Pretoria	Gauteng
South Africa	University of Pretoria	Pretoria	Gauteng
South Africa	Roodepoort Medicross Clinical Research Centre	Roodepoort	Gauteng
South Africa	Sandton Medical Research (Newtown CRC)	Sandton	Gauteng
South Africa	Aliwal Shoal Medical Centre	Umkomaas	Kwa-Zulu Natal
South Africa	Welkom Clinical Trial Centre	Welkom	Free State
United Kingdom	Accellacare Warwickshire	Coventry
United Kingdom	Chapel Allerton Hospital - Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	Accellacare Yorkshire	Shipley	Yorkshire
United States	Orange County Research Institute	Anaheim	California
United States	Injury Care Research	Boise	Idaho
United States	Chicago Clinical Research Institute Inc.	Chicago	Illinois
United States	M3-Emerging Medical Research, LLC	Durham	North Carolina
United States	Arizona Arthritis and Rheumatology Associates (AARA) P.C	Glendale	Arizona
United States	OrthoIndy, Inc.	Greenwood	Indiana
United States	Drug Trials America	Hartsdale	New York
United States	University Of Kansas Medical Center	Kansas City	Kansas
United States	Accellacare-Knoxville	Knoxville	Tennessee
United States	Excel Clinical Research	Las Vegas	Nevada
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Las Vegas Clinical Trials, LLC	North Las Vegas	Nevada
United States	Neuroscience Research Center, LLC	Overland Park	Kansas
United States	Elite Clinical Studies, LLC	Phoenix	Arizona
United States	Progressive Medical Research	Port Orange	Florida
United States	M3-Emerging Medical Research, LLC	Raleigh	North Carolina
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Tekton Research, Inc.	San Antonio	Texas
United States	Acclaim Clinical Research, Inc.	San Diego	California
United States	Gulfcoast Research Institute	Sarasota	Florida
United States	University Orthopedics Center	State College	Pennsylvania
United States	Westlake Medical Research	Thousand Oaks	California
United States	Oakland Medical Research Center	Troy	Michigan
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	North Georgia Clinical Research	Woodstock	Georgia
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Grünenthal GmbH

Countries where clinical trial is conducted

United States,  Bulgaria,  Japan,  Poland,  Romania,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events (TEAEs)		From Baseline up to Week 78
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs) Representing Structural Changes as Assessed by Imaging Methods		From Baseline up to Week 78
Secondary	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.	From Baseline up to Week 12
Secondary	Change from Baseline in WOMAC Physical Function Subscale Score	The WOMAC physical function subscale will be assessed using 11-point NRS, where 0= no difficulty and 10=extreme difficulty.	From Baseline up to Week 12
Secondary	Change from Baseline in WOMAC Stiffness Subscale Score	The WOMAC stiffness subscale will be assessed using an 11-point NRS, where 0= no stiffness and 10= extreme stiffness.	From Baseline up to Week 12
Secondary	Change from Baseline in WOMAC A1 (Walking Pain) Score	The WOMAC A1 score will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain.	From Baseline up to Week 12
Secondary	Change from Baseline in WOMAC Total Score	The WOMAC total score will be calculated as the sum of pain subscale score, stiffness subscale score and physical function subscale score. It will be calculated by averaging all of the scores available for the questions and assessed using an 11-point NRS, where 0=best outcome and 10=worst outcome.	From Baseline up to Week 12
Secondary	Percentage of Participants With at Least 30%, 50% and 70% Reduction From Baseline in WOMAC Pain Subscale Score	The WOMAC pain subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain.	From Baseline up to Week 12
Secondary	Percentage of Participants With at Least 30%, 50% and 70% Reduction From Baseline in WOMAC A1 (Walking Pain) Score	The WOMAC A1 score will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain.	From Baseline up to Week 12
Secondary	Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score	The 7-point PGIC is a complementary assessment of analgesic efficacy on a 7-point scale where 1 = "Very much improved" and 7 = "Very much worse".	From Baseline up to Week 12
Secondary	Change From Baseline in Patient-Specific Functional Scale (PSFS)	The PSFS scale will be assessed using an 11-point NRS, where 0= Unable to perform activity and 10=Able to perform activity at the same level as before your osteoarthritis of the knee started.	From Baseline up to Week 12
Secondary	Change From Baseline in EuroQol-5 Dimension Health Questionnaire 5 Levels (EQ-5D-5L) Score	EQ-5D consists of EQ-5D descriptive system (Index score) and EQ visual analogue scale (VAS). EQ-5D-5L Index Score ranges from 0 to 1, with 0 representing death and 1 representing perfect health. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that range from 0 (worst imaginable) to 100 (best imaginable).	From Baseline up to Week 12
Secondary	Change From Baseline in 36-Item Short-Form (SF-36) Domain Scores	The 8 SF-36 domain scores range from 0 (worst value) to 100 (best value), with higher scores reflecting better health status.	From Baseline up to Week 12