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

NCT05449132 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: KF7039-022021-005020-38U1111-1268-7267
• Study Type: interventional
• Target: 466
• Locations: 5 countries
• Sites: 81

Brief 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.

Conditions

Osteoarthritis

Keywords

Knee; Osteoarthritis; Pain assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  From Baseline up to Week 26

• LS-mean Change From Baseline in WOMAC Physical Function Subscale Score at Week 12 and Week 26

  From Baseline up to Week 12 and Week 26

Study Arms (2)

RTX-GRT7039

EXPERIMENTAL

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

Drug: RTX-GRT7039

Placebo

PLACEBO COMPARATOR

Participants will receive a intra-articular injection of placebo matching 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 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.

Sponsors & Collaborators

• Grünenthal GmbH: lead

Study Sites (81)

Achieve Clinical Research, LLC

Birmingham, Alabama, 35216, United States

Location

Arizona Arthritis and Rheumatology Associates (AARA) P.C

Glendale, Arizona, 85351, United States

Location

Elite Clinical Studies, LLC

Phoenix, Arizona, 85018, United States

Location

Noble Clinical Research

Tucson, Arizona, 85704, United States

Location

Tucson Orthopaedic Research Center

Tucson, Arizona, 85712, United States

Location

Orange County Research Institute

Anaheim, California, 92801, United States

Location

Core Health Care Group

Cerritos, California, 90703, United States

Location

Acclaim Clinical Research, Inc.

San Diego, California, 92120, United States

Location

Dr. Hans Richard Barthel, MD Office Of

Santa Barbara, California, 93108, United States

Location

Medvin Clinical Research

Thousand Oaks, California, 91360, United States

Location

Westlake Medical Research

Thousand Oaks, California, 91360, United States

Location

Allied Biomedical Research Institute

Miami, Florida, 33155, United States

Location

Well Pharma Medical Research, Corp.

Miami, Florida, 33173, United States

Location

Sensible Healthcare LLC

Ocoee, Florida, 34761, United States

Location

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Orlando, Florida, 32801, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32806, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Gulfcoast Research Institute

Sarasota, Florida, 34232, United States

Location

Better Health Clinical Research, Inc.

Newnan, Georgia, 30265, United States

Location

Vista Clinical Research

Newnan, Georgia, 30265, United States

Location

North Georgia Clinical Research

Woodstock, Georgia, 30189, United States

Location

Injury Care Research

Boise, Idaho, 83713, United States

Location

Chicago Clinical Research Institute Inc.

Chicago, Illinois, 60607, United States

Location

Chicago Medical Research, LLC

Hazel Crest, Illinois, 60429, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

Neuroscience Research Center, LLC

Overland Park, Kansas, 66210, United States

Location

DelRicht Research

New Orleans, Louisiana, 70124, United States

Location

LCMC Health Urgent Care - Lakeview

New Orleans, Louisiana, 70124, United States

Location

June DO,PC

Lansing, Michigan, 48911, United States

Location

Oakland Medical Research Center

Troy, Michigan, 48085, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

Las Vegas Clinical Trials, LLC

North Las Vegas, Nevada, 89030, United States

Location

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

Upstate Clinical Research Associates

Williamsville, New York, 14221, United States

Location

Accellacare Research of Charlotte

Charlotte, North Carolina, 28209, United States

Location

Park Road Medical Clinic

Charlotte, North Carolina, 28211, United States

Location

Accellacare of Raleigh

Raleigh, North Carolina, 27609, United States

Location

Raleigh Medical Group

Raleigh, North Carolina, 27609, United States

Location

Accellacare Research of Winston Salem

Winston-Salem, North Carolina, 27103, United States

Location

Gastroenterology Associates of the Piedmont

Winston-Salem, North Carolina, 27103, United States

Location

The Center For Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

University Orthopedics Center

Altoona, Pennsylvania, 16602, United States

Location

University Orthopedics Center

Altoona, Pennsylvania, 9421166, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Antria Inc.

Indiana, Pennsylvania, 15701, United States

Location

Arthritis Group

Philadelphia, Pennsylvania, 19152-3303, United States

Location

University Orthopedics Center

State College, Pennsylvania, 16801, United States

Location

Chan Soon-Shiong Medical Center at Windber

Windber, Pennsylvania, 15963, United States

Location

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, 29601, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Accellacare - Knoxville

Knoxville, Tennessee, 37912, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Charlottesville Medical Research Center LLC

Charlottesville, Virginia, 22911, United States

Location

Arthroscopic Center, Copenhagen University Hospital

Amager, 2650, Denmark

Location

The Parker Institute-Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

Hospital de Cascais

Alcabideche, 2755-009, Portugal

Location

Hospital Dos Lusiadas Lisboa

Lisbon, 1500-458, Portugal

Location

Hospital CUF Porto

Porto, 4100-180, Portugal

Location

Complejo Hospitalario Universitario A Coruna

A Coruña, 15006, Spain

Location

Hospital Sanitas Cima

Barcelona, 08034, Spain

Location

Hospital General Universitario de Elche

Elche, 03203, Spain

Location

Hospital Universitaro De Elche

Elche, 7105, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Accellacare Alcobendas

Madrid, 28100, Spain

Location

Hospital Universitario Virgen De La Arrixaca (Huva)

Murcia, 30120, Spain

Location

Consorci Corporacio Sanitaria Parc Tauli

Sabadell, 08208, Spain

Location

Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli

Sabadell, 08208, Spain

Location

Clinica Gaias

Santiago de Compostela, 15702, Spain

Location

Complexo Hospitalario Universitario De Santiago De Compostela

Santiago de Compostela, 15706, Spain

Location

Hospital Clinico Universitario De Santiago De Compostela

Santiago de Compostela, 15706, Spain

Location

Hospital Quironsalud Infanta Luisa

Seville, 41010, Spain

Location

Accellacare-Northamptonshire

Corby, Northamptonshire, NN18 9EZ, United Kingdom

Location

Robert Jones & Agnes Hunt Orthopaedic Hospital - Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, Powys, SY10 7AG, United Kingdom

Location

Royal Orthopaedic Hospital - Nhs Foundation Trust

Birmingham, B31 2AP, United Kingdom

Location

Glasgow Royal Infirmary - Greater Glasgow Health Board

Glasgow, G4 0SF, United Kingdom

Location

Accellacare North London

Northwood, HA6 2RN, United Kingdom

Location

Accellacare South London

Orpington, BR5 3QG, United Kingdom

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: July 4, 2022
• First Posted: July 8, 2022
• Study Start: September 26, 2022
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: March 18, 2026
• Results First Posted: March 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (56); DK (2); GB (6); ES (14); PT (3)