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

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

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.

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): 466
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Amager, Denmark, 2650
    • Arthroscopic Center, Copenhagen University Hospital
  • Frederiksberg, Denmark, 2000
    • The Parker Institute-Frederiksberg Hospital
• Portugal
  • Alcabideche, Portugal, 2755-009
    • Hospital de Cascais
  • Lisbon, Portugal, 1500-458
    • Hospital Dos Lusiadas Lisboa
  • Porto, Portugal, 4100-180
    • Hospital Cuf porto
• Spain
  • A Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruña
  • Barcelona, Spain, 08034
    • Hospital Sanitas CIMA
  • Elche, Spain, 03203
    • Hospital General Universitario de Elche
  • Elche, Spain, 7105
    • Hospital Universitaro De Elche
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa
  • Madrid, Spain, 28100
    • Accellacare Alcobendas
  • Murcia, Spain, 30120
    • Hospital Universitario Virgen De La Arrixaca (Huva)
  • Sabadell, Spain, 08208
    • Consorci Corporació Sanitària Parc Taulí
  • Sabadell, Spain, 08208
    • Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli
  • Santiago de Compostela, Spain, 15702
    • Clinica Gaias
  • Santiago de Compostela, Spain, 15706
    • Hospital Clínico Universitario de Santiago de Compostela
  • Santiago de Compostela, Spain, 15706
    • Complexo Hospitalario Universitario de Santiago de Compostela
  • Seville, Spain, 41010
    • Hospital Quironsalud Infanta Luisa
• United Kingdom
  • Birmingham, United Kingdom, B31 2AP
    • Royal Orthopaedic Hospital - Nhs Foundation Trust
  • Glasgow, United Kingdom, G4 0SF
    • Glasgow Royal Infirmary - Greater Glasgow Health Board
  • Northwood, United Kingdom, HA6 2RN
    • Accellacare North London
  • Orpington, United Kingdom, BR5 3QG
    • Accellacare South London
  • Northamptonshire
    • Corby, Northamptonshire, United Kingdom, NN18 9EZ
      • Accellacare-Northamptonshire
  • Powys
    • Oswestry, Powys, United Kingdom, SY10 7AG
      • Robert Jones & Agnes Hunt Orthopaedic Hospital - Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Achieve Clinical Research, LLC
  • Arizona
    • Glendale, Arizona, United States, 85351
      • Arizona Arthritis and Rheumatology Associates (AARA) P.C
    • Phoenix, Arizona, United States, 85018
      • Elite Clinical Studies, LLC
    • Tucson, Arizona, United States, 85704
      • Noble Clinical Research
    • Tucson, Arizona, United States, 85712
      • Tucson Orthopaedic Research Center
  • California
    • Anaheim, California, United States, 92801
      • Orange County Research Institute
    • Cerritos, California, United States, 90703
      • Core Health Care Group
    • San Diego, California, United States, 92120
      • Acclaim Clinical Research, Inc.
    • Santa Barbara, California, United States, 93108
      • Dr. Hans Richard Barthel, MD Office Of
    • Thousand Oaks, California, United States, 91360
      • Westlake Medical Research
    • Thousand Oaks, California, United States, 91360
      • Medvin Clinical Research
  • Florida
    • Miami, Florida, United States, 33155
      • Allied Biomedical Research Institute
    • Miami, Florida, United States, 33173
      • Well Pharma Medical Research, Corp.
    • Ocoee, Florida, United States, 34761
      • Sensible Healthcare LLC
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
    • Orlando, Florida, United States, 32806
      • Clinical Neuroscience Solutions, Inc.
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
    • Sarasota, Florida, United States, 34232
      • Gulfcoast Research Institute
  • Georgia
    • Newnan, Georgia, United States, 30265
      • Better Health Clinical Research, Inc.
    • Newnan, Georgia, United States, 30265
      • Vista Clinical Research
    • Woodstock, Georgia, United States, 30189
      • North Georgia Clinical Research
  • Idaho
    • Boise, Idaho, United States, 83713
      • Injury Care Research
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Chicago Clinical Research Institute Inc.
    • Hazel Crest, Illinois, United States, 60429
      • Chicago Medical Research, LLC
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Medisphere Medical Research Center, Llc
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Neuroscience Research Center, LLC
  • Louisiana
    • New Orleans, Louisiana, United States, 70124
      • DelRicht Research
    • New Orleans, Louisiana, United States, 70124
      • LCMC Health Urgent Care - Lakeview
  • Michigan
    • Lansing, Michigan, United States, 48911
      • June DO,PC
    • Troy, Michigan, United States, 48085
      • Oakland Medical Research Center
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Sundance Clinical Research, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Excel Clinical Research
    • North Las Vegas, Nevada, United States, 89030
      • Las Vegas Clinical Trials, LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
  • New York
    • Hartsdale, New York, United States, 10530
      • Drug Trials America
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • Accellacare Research of Charlotte
    • Charlotte, North Carolina, United States, 28211
      • Park Road Medical Clinic
    • Raleigh, North Carolina, United States, 27609
      • Raleigh Medical Group
    • Raleigh, North Carolina, United States, 27609
      • Accellacare of Raleigh
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research
    • Winston-Salem, North Carolina, United States, 27103
      • Gastroenterology Associates of the Piedmont
    • Winston-Salem, North Carolina, United States, 27103
      • Accellacare Research of Winston Salem
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • University Orthopedics Center
    • Altoona, Pennsylvania, United States, 9421166
      • University Orthopedics Center
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research
    • Indiana, Pennsylvania, United States, 15701
      • Antria Inc.
    • Philadelphia, Pennsylvania, United States, 19152-3303
      • Arthritis Group
    • State College, Pennsylvania, United States, 16801
      • University Orthopedics Center
    • Windber, Pennsylvania, United States, 15963
      • Chan Soon-Shiong Medical Center at Windber
  • South Carolina
    • Greenville, South Carolina, United States, 29601
      • PCPMG Clinical Research Unit, LLC
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Tennessee
    • Knoxville, Tennessee, United States, 37912
      • Accellacare - Knoxville
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research Center LLC

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 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.

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 a intra-articular injection 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 a intra-articular injection of placebo matching 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 Western Ontario and McMaster Universities Osteoarthritis Index (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 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

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 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 Change From Baseline in WOMAC Physical Function Subscale Score at Week 12 and 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 17 questions using an 11-point numeric rating scale (NRS, from 0 = no difficulty to 10 = extreme difficulty). The scores are averaged over the number of questions.	From Baseline up to Week 12 and Week 26

Collaborators and Investigators

• Sponsor: Grünenthal GmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Actual): August 15, 2024
• Study Completion (Actual): August 15, 2024

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 8, 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; Knee; Pain assessment
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: KF7039-02; 2021-005020-38 (EudraCT Number); U1111-1268-7267 (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