Open-label Trial to Check the Safety and Tolerability of... | NCT05377489

ID	Type	Description
2021-005046-15	EudraCT Number
U1111-1268-7230	Other Identifier	Universal Trial Number
2024-515709-24-00	EU Trial (CTIS) Number

Status Module

Label	Type	Description	Intervention Names
RTX-GRT7039	Experimental	Participants 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.	Drug: RTX-GRT7039

Name	Type	Description	Arm Group Labels	Other Names
RTX-GRT7039	Drug	RTX-GRT7039 monoarticular injections or bilateral intra-articular injections.	RTX-GRT7039

Measure	Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)		From Baseline up to Week 78
Number of Participants With TEAEs Leading to Study Discontinuation		From Baseline up to Week 78

Measure	Description	Time Frame
Number of Participants With TEAEs Representing Structural Changes as Assessed by Imaging Methods		From Baseline up to Week 78
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.

Eligibility Module

Eligibility Criteria

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.

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Arthritis and Rheumatology Associates (AARA) P.C		Glendale	Arizona	85306	United States
Elite Clinical Studies, LLC

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	RTX-GRT7039	RTX-GRT7039 was administered as an intra-articular injection or repeated intra-articular injections of RTX-GRT7039 in participants with moderate to severe pain associated with osteoarthritis (OA) of the knee, despite receiving continued treatment with optimal standard-of-care (SoC) or who are unable to receive SoC treatment due to contraindications or intolerability. Participants received injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with higher pain severity), or both knees up to Week 52. Participants received up to four repeated injections between 3 and 12 months after the first injection based on the persistence or return of pain, with a minimum interval of 12 weeks between injections.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 9, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Posted

Count of Participants

Participants

From Baseline up to Week 78

ID	Title	Description
OG000	RTX-GRT7039	RTX-GRT7039 was administered as an intra-articular injection or repeated intra-articular injections of RTX-GRT7039 in participants with moderate to severe pain associated with OA of the knee, despite receiving continued treatment with optimal SoC or who are unable to receive SoC treatment due to contraindications or intolerability. Participants received injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with higher pain severity), or both knees up to Week 52. Participants received up to four repeated injections between 3 and 12 months after the first injection based on the persistence or return of pain, with a minimum interval of 12 weeks between injections.

Units	Counts
Participants	OG000714

Title

Denominators

Categories

Title	Measurements
	OG000394

Primary

Number of Participants With TEAEs Leading to Study Discontinuation

Posted

Count of Participants

Participants

From Baseline up to Week 78

ID	Title	Description
OG000	RTX-GRT7039	RTX-GRT7039 was administered as an intra-articular injection or repeated intra-articular injections of RTX-GRT7039 in participants with moderate to severe pain associated with OA of the knee, despite receiving continued treatment with optimal SoC or who are unable to receive SoC treatment due to contraindications or intolerability. Participants received injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with higher pain severity), or both knees up to Week 52. Participants received up to four repeated injections between 3 and 12 months after the first injection based on the persistence or return of pain, with a minimum interval of 12 weeks between injections.

Units	Counts
Participants	OG000

Secondary

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

Posted

Count of Participants

Participants

From Baseline up to Week 78

ID	Title	Description
OG000	RTX-GRT7039	RTX-GRT7039 was administered as an intra-articular injection or repeated intra-articular injections of RTX-GRT7039 in participants with moderate to severe pain associated with OA of the knee, despite receiving continued treatment with optimal SoC or who are unable to receive SoC treatment due to contraindications or intolerability. Participants received injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with higher pain severity), or both knees up to Week 52. Participants received up to four repeated injections between 3 and 12 months after the first injection based on the persistence or return of pain, with a minimum interval of 12 weeks between injections.

Units	Counts
Participants	OG000

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.

Results reported separately for Index Knee and Non-index Knee

Posted

Mean

Standard Deviation

units on a scale

From Baseline up to Week 12

ID	Title	Description
OG000	RTX-GRT7039	RTX-GRT7039 was administered as an intra-articular injection or repeated intra-articular injections of RTX-GRT7039 in participants with moderate to severe pain associated with OA of the knee, despite receiving continued treatment with optimal SoC or who are unable to receive SoC treatment due to contraindications or intolerability. Participants received injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with higher pain severity), or both knees up to Week 52. Participants received up to four repeated injections between 3 and 12 months after the first injection based on the persistence or return of pain, with a minimum interval of 12 weeks between injections.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	RTX-GRT7039	RTX-GRT7039 was administered as an intra-articular injection or repeated intra-articular injections of RTX-GRT7039 in participants with moderate to severe pain associated with osteoarthritis (OA) of the knee, despite receiving continued treatment with optimal standard-of-care (SoC) or who are unable to receive SoC treatment due to contraindications or intolerability. Participants received injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with highest pain severity), or each of both knees up to Week 52. Participants received up to four repeated injections between 3 and 12 months after the first injection based on the persistence or return of pain, with a minimum interval of 12 weeks between injections.	4	714	58	714	54	714

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG00019 events18 affected714 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0005 events5 affected714 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Synovial rupture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Arthritis bacterial	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected714 at risk
Pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected714 at risk
Localised infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Otitis media	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected714 at risk
Aortic valve disease	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Cardiac arrest	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Cardiac failure	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Myocardial infarction	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected714 at risk
Dizziness	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Loss of consciousness	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected714 at risk
Intraductal papillary mucinous neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk
Aortic rupture	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected714 at risk

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases