Trial Outcomes & Findings for Comparison of a Single RTX-GRT7039 and Placebo Intra-articular Injection for Pain Associated With Osteoarthritis of the Knee (NCT NCT05449132)
NCT ID: NCT05449132
Last Updated: 2026-03-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
466 participants
Primary outcome timeframe
From Baseline up to Week 12
Results posted on
2026-03-18
Participant Flow
Participant milestones
| Measure |
RTX-GRT7039
Participants received one intra-articular injection of RTX-GRT7039 on Day 1 of the 52-week double-blind treatment period.
|
Placebo
Participants received one intra-articular injection of placebo matching RTX-GRT7039 on Day 1 of the 52-week double-blind treatment period.
|
|---|---|---|
|
Overall Study
STARTED
|
231
|
235
|
|
Overall Study
COMPLETED
|
207
|
200
|
|
Overall Study
NOT COMPLETED
|
24
|
35
|
Reasons for withdrawal
| Measure |
RTX-GRT7039
Participants received one intra-articular injection of RTX-GRT7039 on Day 1 of the 52-week double-blind treatment period.
|
Placebo
Participants received one intra-articular injection of placebo matching RTX-GRT7039 on Day 1 of the 52-week double-blind treatment period.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
13
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Adverse Event
|
2
|
6
|
|
Overall Study
Other
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
9
|
7
|
|
Overall Study
Lack of Efficacy
|
4
|
4
|
Baseline Characteristics
Comparison of a Single RTX-GRT7039 and Placebo Intra-articular Injection for Pain Associated With Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
RTX-GRT7039
n=231 Participants
Participants received one intra-articular injection of RTX-GRT7039 during the 52-week double-blind treatment period.
Reporting groups (Full Analysis Set \[FAS\] and Safety Analysis Set \[SAS\]) corresponds to all subjects with an Investigational medicinal product (IMP) administration or matching placebo (including incomplete administrations): FAS - based on treatment as randomized (i.e. as planned); SAF - based on treatment received.
|
Placebo
n=235 Participants
Participants received one intra-articular injection of placebo matching to RTX-GRT7039 during the 52-week double-blind treatment period.
Reporting groups (Full Analysis Set \[FAS\] and Safety Analysis Set \[SAS\]) corresponds to all subjects with an Investigational medicinal product (IMP) administration or matching placebo (including incomplete administrations): FAS - based on treatment as randomized (i.e. as planned); SAF - based on treatment received.
|
Total
n=466 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.0 years
STANDARD_DEVIATION 8.54 • n=110 Participants
|
65.7 years
STANDARD_DEVIATION 8.68 • n=114 Participants
|
65.4 years
STANDARD_DEVIATION 8.61 • n=224 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=110 Participants
|
159 Participants
n=114 Participants
|
307 Participants
n=224 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=110 Participants
|
76 Participants
n=114 Participants
|
159 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
60 Participants
n=110 Participants
|
59 Participants
n=114 Participants
|
119 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
165 Participants
n=110 Participants
|
168 Participants
n=114 Participants
|
333 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=110 Participants
|
8 Participants
n=114 Participants
|
14 Participants
n=224 Participants
|
PRIMARY outcome
Timeframe: From Baseline up to Week 12Difference 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.
Outcome measures
| Measure |
Placebo
n=235 Participants
Participants received one intra-articular injection of placebo matching RTX-GRT7039 on Day 1 of the 52-week double-blind treatment period.
|
RTX-GRT7039
n=231 Participants
Participants received one intra-articular injection of RTX-GRT7039 on Day 1 of the 52-week double-blind treatment period.
|
|---|---|---|
|
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
|
-2.99 score on a scale
Standard Error 0.17
|
-3.25 score on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: From Baseline up to Week 26Difference 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.
Outcome measures
| Measure |
Placebo
n=235 Participants
Participants received one intra-articular injection of placebo matching RTX-GRT7039 on Day 1 of the 52-week double-blind treatment period.
|
RTX-GRT7039
n=231 Participants
Participants received one intra-articular injection of RTX-GRT7039 on Day 1 of the 52-week double-blind treatment period.
|
|---|---|---|
|
LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 26
|
-2.82 score on a scale
Standard Error 0.17
|
-3.27 score on a scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: From Baseline up to Week 12 and Week 26Difference 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.
Outcome measures
| Measure |
Placebo
n=235 Participants
Participants received one intra-articular injection of placebo matching RTX-GRT7039 on Day 1 of the 52-week double-blind treatment period.
|
RTX-GRT7039
n=231 Participants
Participants received one intra-articular injection of RTX-GRT7039 on Day 1 of the 52-week double-blind treatment period.
|
|---|---|---|
|
LS-mean Change From Baseline in WOMAC Physical Function Subscale Score at Week 12 and Week 26
Week 12
|
-2.86 score on a scale
Standard Error 0.16
|
-3.17 score on a scale
Standard Error 0.16
|
|
LS-mean Change From Baseline in WOMAC Physical Function Subscale Score at Week 12 and Week 26
Week 26
|
-2.65 score on a scale
Standard Error 0.16
|
-3.16 score on a scale
Standard Error 0.16
|
Adverse Events
RTX-GRT7039
Serious events: 11 serious events
Other events: 41 other events
Deaths: 0 deaths
Placebo
Serious events: 15 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RTX-GRT7039
n=231 participants at risk
Participants receive one intra-articular injection of RTX-GRT7039 on Day 1 of the 52-week double-blind treatment period.
|
Placebo
n=235 participants at risk
Participants received one intra-articular injection of placebo matching RTX-GRT7039 on Day 1 of the 52-week double-blind treatment period.
|
|---|---|---|
|
Nervous system disorders
Cerebral ischaemia
|
0.43%
1/231 • Up to 52 weeks.
|
0.00%
0/235 • Up to 52 weeks.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/231 • Up to 52 weeks.
|
0.43%
1/235 • Up to 52 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.43%
1/231 • Up to 52 weeks.
|
0.00%
0/235 • Up to 52 weeks.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/231 • Up to 52 weeks.
|
0.43%
1/235 • Up to 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.2%
5/231 • Up to 52 weeks.
|
3.0%
7/235 • Up to 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/231 • Up to 52 weeks.
|
0.85%
2/235 • Up to 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.43%
1/231 • Up to 52 weeks.
|
0.00%
0/235 • Up to 52 weeks.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/231 • Up to 52 weeks.
|
0.43%
1/235 • Up to 52 weeks.
|
|
Infections and infestations
Sepsis
|
0.00%
0/231 • Up to 52 weeks.
|
0.43%
1/235 • Up to 52 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/231 • Up to 52 weeks.
|
0.43%
1/235 • Up to 52 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/231 • Up to 52 weeks.
|
0.43%
1/235 • Up to 52 weeks.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.43%
1/231 • Up to 52 weeks.
|
0.00%
0/235 • Up to 52 weeks.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/231 • Up to 52 weeks.
|
0.43%
1/235 • Up to 52 weeks.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/231 • Up to 52 weeks.
|
0.43%
1/235 • Up to 52 weeks.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.43%
1/231 • Up to 52 weeks.
|
0.00%
0/235 • Up to 52 weeks.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/231 • Up to 52 weeks.
|
0.43%
1/235 • Up to 52 weeks.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/231 • Up to 52 weeks.
|
0.43%
1/235 • Up to 52 weeks.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/231 • Up to 52 weeks.
|
0.43%
1/235 • Up to 52 weeks.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.43%
1/231 • Up to 52 weeks.
|
0.00%
0/235 • Up to 52 weeks.
|
Other adverse events
| Measure |
RTX-GRT7039
n=231 participants at risk
Participants receive one intra-articular injection of RTX-GRT7039 on Day 1 of the 52-week double-blind treatment period.
|
Placebo
n=235 participants at risk
Participants received one intra-articular injection of placebo matching RTX-GRT7039 on Day 1 of the 52-week double-blind treatment period.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Procedural pain
|
12.1%
28/231 • Up to 52 weeks.
|
5.5%
13/235 • Up to 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
13/231 • Up to 52 weeks.
|
10.2%
24/235 • Up to 52 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results (or parts thereof) of this trial may be published as a publication (e.g., journal publication) or at a congress (e.g., as a poster or presentation). The sponsor reserves the right to review any proposed full publication, poster, or presentation of the results of this trial by the coordinating investigator before they are submitted for publication or public disclosure.
- Publication restrictions are in place
Restriction type: OTHER