Comparison of a Single RTX-GRT7039 and Placebo Intra-articular Injection for Pain Associated With Osteoarthritis of the Knee

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05449132
• Other study ID #: KF7039-02
• Secondary ID: 2021-005020-38U1
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 26, 2022
• Est. completion date: February 2024

Study information

• Verified date: February 2024
• Source: Grünenthal GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of single injection of RTX-GRT7039 versus placebo 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 52 weeks.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: February 2024
• Est. primary completion date: February 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 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 in 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• RTX-GRT7039
RTX-GRT7039 intra-articular injection.
• Placebo
Placebo matching RTX-GRT7039 intra-articular injection.

Locations

Country	Name	City	State
Denmark	Arthroscopic Center, Copenhagen University Hospital	Amager-Hvidovre
Denmark	The Parker Institute-Frederiksberg Hospital	Frederiksberg
Portugal	Hospital de Cascais	Alcabideche
Portugal	Hospital Dos Lusiadas Lisboa	Lisboa
Portugal	Hospital CUF Porto	Porto
Spain	Complejo Hospitalario Universitario A Coruna	A Coruña
Spain	Hospital Sanitas Cima	Barcelona
Spain	Hospital General Universitario de Elche	Elche
Spain	Hospital Universitaro De Elche	Elche
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Accellacare Alcobendas	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Virgen De La Arrixaca (Huva)	Murcia
Spain	Consorci Corporacio Sanitaria Parc Tauli	Sabadell
Spain	Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli	Sabadell
Spain	Clinica Gaias	Santiago de Compostela
Spain	Complexo Hospitalario Universitario De Santiago De Compostela	Santiago De Compostela
Spain	Hospital Clinico Universitario De Santiago De Compostela	Santiago De Compostela
Spain	Hospital Quironsalud Infanta Luisa	Sevilla
United Kingdom	Accellacare-Northamptonshire	Corby	Northamptonshire
United Kingdom	Glasgow Royal Infirmary - Greater Glasgow Health Board	Glasgow
United Kingdom	Royal Orthopaedic Hospital - Nhs Foundation Trust	Northfield Birminham
United Kingdom	Accellacare North London	Northwood
United Kingdom	Accellacare South London	Orpington
United Kingdom	Robert Jones & Agnes Hunt Orthopaedic Hospital - Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust	Oswestry	Powys
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	University Orthopedics Center	Altoona	Pennsylvania
United States	University Orthopedics Center	Altoona	Pennsylvania
United States	Orange County Research Institute	Anaheim	California
United States	Achieve Clinical Research, LLC	Birmingham	Alabama
United States	Injury Care Research	Boise	Idaho
United States	Core Health Care Group	Cerritos	California
United States	Accellacare Research of Charlotte	Charlotte	North Carolina
United States	Park Road Medical Clinic	Charlotte	North Carolina
United States	Charlottesville Medical Research Center LLC	Charlottesville	Virginia
United States	Chicago Clinical Research Institute Inc.	Chicago	Illinois
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Arizona Arthritis and Rheumatology Associates (AARA) P.C	Glendale	Arizona
United States	PCPMG Clinical Research Unit, LLC	Greenville	South Carolina
United States	Drug Trials America	Hartsdale	New York
United States	Chicago Medical Research, LLC	Hazel Crest	Illinois
United States	Antria Inc.	Indiana	Pennsylvania
United States	Accellacare - Knoxville	Knoxville	Tennessee
United States	June DO,PC	Lansing	Michigan
United States	Excel Clinical Research	Las Vegas	Nevada
United States	Allied Biomedical Research Institute	Miami	Florida
United States	Well Pharma Medical Research, Corp.	Miami	Florida
United States	DelRicht Research	New Orleans	Louisiana
United States	LCMC Health Urgent Care - Lakeview	New Orleans	Louisiana
United States	Better Health Clinical Research, Inc.	Newnan	Georgia
United States	Vista Clinical Research	Newnan	Georgia
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Las Vegas Clinical Trials, LLC	North Las Vegas	Nevada
United States	Sensible Healthcare LLC	Ocoee	Florida
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Clinical Neuroscience Solutions, Inc. dba CNS Healthcare	Orlando	Florida
United States	Neuroscience Research Center, LLC	Overland Park	Kansas
United States	Arthritis Group	Philadelphia	Pennsylvania
United States	Elite Clinical Studies, LLC	Phoenix	Arizona
United States	Progressive Medical Research	Port Orange	Florida
United States	Accellacare of Raleigh	Raleigh	North Carolina
United States	Raleigh Medical Group	Raleigh	North Carolina
United States	Health Concepts	Rapid City	South Dakota
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Acclaim Clinical Research, Inc.	San Diego	California
United States	Dr. Hans Richard Barthel, MD Office Of	Santa Barbara	California
United States	Gulfcoast Research Institute	Sarasota	Florida
United States	University Orthopedics Center	State College	Pennsylvania
United States	Medvin Clinical Research	Thousand Oaks	California
United States	Westlake Medical Research	Thousand Oaks	California
United States	Oakland Medical Research Center	Troy	Michigan
United States	Noble Clinical Research	Tucson	Arizona
United States	Tucson Orthopaedic Research Center	Tucson	Arizona
United States	Upstate Clinical Research Associates	Williamsville	New York
United States	Chan Soon-Shiong Medical Center at Windber	Windber	Pennsylvania
United States	Accellacare Research of Winston Salem	Winston-Salem	North Carolina
United States	Gastroenterology Associates of the Piedmont	Winston-Salem	North Carolina
United States	The Center For Clinical Research	Winston-Salem	North Carolina
United States	North Georgia Clinical Research	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Grünenthal GmbH

Countries where clinical trial is conducted

United States,  Denmark,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score	The WOMAC pain subscale will be assessed using an 11-point numeric rating scale (NRS), where 0= no pain and 10=worst pain imaginable.	From Baseline up to Week 12
Secondary	Change 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 imaginable.	From Baseline up to Week 52
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 52
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs)		From Baseline up to Week 52
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 52
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=better outcome and 10=worst outcome.	From Baseline up to Week 52
Secondary	Change from Baseline in WOMAC A1 (Walking Pain) Subscale Score	The WOMAC A1 subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable.	From Baseline up to Week 52
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 imaginable.	From Baseline up to Week 52
Secondary	Percentage of Participants With at Least 30%, 50% and 70% Reduction From Baseline in WOMAC A1 (Walking Pain) Subscale Score	The WOMAC A1 subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable.	From Baseline up to Week 52
Secondary	Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response	OMERACT-OARSI response: A high improvement of >=50% (percentage change) and >=2 (absolute change) in either the WOMAC pain subscale score or WOMAC physical function subscale score, OR an improvement in at least 2 of the following 3: Improvement of >=20% (percentage change) and >=1 (absolute change) in the WOMAC pain subscale score.; Improvement of >=20% (percentage change) and >=1 (absolute change) in the WOMAC physical function subscale score.; Improvement of >=20% (percentage change) and >=10 (absolute change) in Patient Global Assessment (PGA) of osteoarthritis. Absolute values will be normalized to the 0 (no pain) to 100 scale (higher pain/difficulty).	From Baseline up to Week 52
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 52
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 1.0 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 52
Secondary	Change From Baseline in 36-Item Short-Form (SF-36) Domain Scores	The 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 52
Secondary	Number of Participants Reporting Durability of Effect	Durability of effect is defined as time from an improvement in WOMAC pain subscale to pain recurrence. Pain recurrence is defined as no reduction of >=30% from baseline in the WOMAC Pain subscale score (assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable).	From Baseline up to Week 52