Trial Outcomes & Findings for Efficacy and Safety of RTX-GRT7039 in Adult Subjects With Knee Osteoarthritis (NCT NCT05248386)
NCT ID: NCT05248386
Last Updated: 2025-08-12
Results Overview
Difference in mean change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score at Week 12 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 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
469 participants
Primary outcome timeframe
Baseline up to Week 12
Results posted on
2025-08-12
Participant Flow
Participant milestones
| Measure |
RTX-GRT7039
Participants received intra-articular injections of RTX-GRT7039 (2 injections: Day 1 and Week 26) 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
Participants received intra-articular injections of placebo matching to RTX-GRT7039 (2 injections: Day 1 and Week 26) 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.
|
|---|---|---|
|
Overall Study
STARTED
|
234
|
232
|
|
Overall Study
COMPLETED
|
202
|
204
|
|
Overall Study
NOT COMPLETED
|
32
|
28
|
Reasons for withdrawal
| Measure |
RTX-GRT7039
Participants received intra-articular injections of RTX-GRT7039 (2 injections: Day 1 and Week 26) 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
Participants received intra-articular injections of placebo matching to RTX-GRT7039 (2 injections: Day 1 and Week 26) 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.
|
|---|---|---|
|
Overall Study
Technical problems
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
15
|
10
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Adverse Event
|
2
|
4
|
|
Overall Study
Other
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
14
|
12
|
Baseline Characteristics
Efficacy and Safety of RTX-GRT7039 in Adult Subjects With Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
RTX-GRT7039
n=234 Participants
Participants received intra-articular injections of RTX-GRT7039 (2 injections: Day 1 and Week 26) during the 52-week double-blind treatment period.
|
Placebo
n=232 Participants
Participants received intra-articular injections of placebo matching to RTX-GRT7039 (2 injections: Day 1 and Week 26) during the 52-week double-blind treatment period.
|
Total
n=466 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 8.40 • n=5 Participants
|
67.1 years
STANDARD_DEVIATION 8.32 • n=7 Participants
|
66.8 years
STANDARD_DEVIATION 8.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
163 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
337 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
214 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
428 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 12Difference in mean change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score at Week 12 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 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine).
Outcome measures
| Measure |
RTX-GRT7039
n=234 Participants
Participants received intra-articular injections of RTX-GRT7039 (2 injections: Day 1 and Week 26) during the 52-week double-blind treatment period.
|
Placebo
n=232 Participants
Participants received intra-articular injections of placebo matching to RTX-GRT7039 (2 injections: Day 1 and Week 26) during the 52-week double-blind treatment period.
|
|---|---|---|
|
Least Squares Mean (Standard Error) [LS-mean (SE)] Change From Baseline in WOMAC Pain Subscale Score at Week 12
|
-2.959 score on a scale
Standard Error 0.15
|
-2.847 score on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: From Baseline up to Week 26Difference in mean change from baseline in WOMAC pain 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 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine).
Outcome measures
| Measure |
RTX-GRT7039
n=234 Participants
Participants received intra-articular injections of RTX-GRT7039 (2 injections: Day 1 and Week 26) during the 52-week double-blind treatment period.
|
Placebo
n=232 Participants
Participants received intra-articular injections of placebo matching to RTX-GRT7039 (2 injections: Day 1 and Week 26) during the 52-week double-blind treatment period.
|
|---|---|---|
|
LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 26
|
-2.564 score on a scale
Standard Error 0.15
|
-2.597 score on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: From Baseline up to Week 52Difference in mean change from baseline in WOMAC pain subscale score at Week 52 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 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine).
Outcome measures
| Measure |
RTX-GRT7039
n=234 Participants
Participants received intra-articular injections of RTX-GRT7039 (2 injections: Day 1 and Week 26) during the 52-week double-blind treatment period.
|
Placebo
n=232 Participants
Participants received intra-articular injections of placebo matching to RTX-GRT7039 (2 injections: Day 1 and Week 26) during the 52-week double-blind treatment period.
|
|---|---|---|
|
LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 52
|
-2.686 score on a scale
Standard Error 0.18
|
-2.823 score on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: From Baseline up to Week 12Difference in mean change from baseline in WOMAC physical function subscale score at Week 12 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 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine).
Outcome measures
| Measure |
RTX-GRT7039
n=234 Participants
Participants received intra-articular injections of RTX-GRT7039 (2 injections: Day 1 and Week 26) during the 52-week double-blind treatment period.
|
Placebo
n=232 Participants
Participants received intra-articular injections of placebo matching to RTX-GRT7039 (2 injections: Day 1 and Week 26) during the 52-week double-blind treatment period.
|
|---|---|---|
|
LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 12
|
-2.802 score on a scale
Standard Error 0.14
|
-2.740 score on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: From Baseline up to 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 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine).
Outcome measures
| Measure |
RTX-GRT7039
n=234 Participants
Participants received intra-articular injections of RTX-GRT7039 (2 injections: Day 1 and Week 26) during the 52-week double-blind treatment period.
|
Placebo
n=232 Participants
Participants received intra-articular injections of placebo matching to RTX-GRT7039 (2 injections: Day 1 and Week 26) during the 52-week double-blind treatment period.
|
|---|---|---|
|
LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 26
|
-2.503 score on a scale
Standard Error 0.14
|
-2.552 score on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: From Baseline up to Week 52Difference 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 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine).
Outcome measures
| Measure |
RTX-GRT7039
n=234 Participants
Participants received intra-articular injections of RTX-GRT7039 (2 injections: Day 1 and Week 26) during the 52-week double-blind treatment period.
|
Placebo
n=232 Participants
Participants received intra-articular injections of placebo matching to RTX-GRT7039 (2 injections: Day 1 and Week 26) during the 52-week double-blind treatment period.
|
|---|---|---|
|
LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 52
|
-2.664 score on a scale
Standard Error 0.16
|
-2.728 score on a scale
Standard Error 0.16
|
Adverse Events
RTX-GRT7039
Serious events: 17 serious events
Other events: 53 other events
Deaths: 0 deaths
Placebo
Serious events: 14 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RTX-GRT7039
n=234 participants at risk
Participants received intra-articular injections of RTX-GRT7039 (2 injections: Day 1 and Week 26) during the 52-week double-blind treatment period
|
Placebo
n=232 participants at risk
Participants received intra-articular injections of placebo matching to RTX-GRT7039 (2 injections: Day 1 and Week 26) during the 52-week double-blind treatment period.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.43%
1/234 • Up to 52 weeks
|
0.00%
0/232 • Up to 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.43%
1/234 • Up to 52 weeks
|
0.00%
0/232 • Up to 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/234 • Up to 52 weeks
|
0.43%
1/232 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/234 • Up to 52 weeks
|
0.43%
1/232 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/234 • Up to 52 weeks
|
0.43%
1/232 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/234 • Up to 52 weeks
|
0.43%
1/232 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/234 • Up to 52 weeks
|
0.43%
1/232 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/234 • Up to 52 weeks
|
0.43%
1/232 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.43%
1/234 • Up to 52 weeks
|
0.00%
0/232 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/234 • Up to 52 weeks
|
0.43%
1/232 • Up to 52 weeks
|
|
Vascular disorders
Hypertension
|
0.85%
2/234 • Up to 52 weeks
|
0.00%
0/232 • Up to 52 weeks
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/234 • Up to 52 weeks
|
0.43%
1/232 • Up to 52 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.43%
1/234 • Up to 52 weeks
|
0.00%
0/232 • Up to 52 weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/234 • Up to 52 weeks
|
0.43%
1/232 • Up to 52 weeks
|
|
Nervous system disorders
Altered state of consciousness
|
0.43%
1/234 • Up to 52 weeks
|
0.00%
0/232 • Up to 52 weeks
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.43%
1/234 • Up to 52 weeks
|
0.00%
0/232 • Up to 52 weeks
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/234 • Up to 52 weeks
|
0.43%
1/232 • Up to 52 weeks
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/234 • Up to 52 weeks
|
0.43%
1/232 • Up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.43%
1/234 • Up to 52 weeks
|
0.00%
0/232 • Up to 52 weeks
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.43%
1/234 • Up to 52 weeks
|
0.00%
0/232 • Up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
4/234 • Up to 52 weeks
|
1.3%
3/232 • Up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.43%
1/234 • Up to 52 weeks
|
0.43%
1/232 • Up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.85%
2/234 • Up to 52 weeks
|
0.00%
0/232 • Up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.43%
1/234 • Up to 52 weeks
|
0.00%
0/232 • Up to 52 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/234 • Up to 52 weeks
|
0.43%
1/232 • Up to 52 weeks
|
|
Infections and infestations
Diverticulitis
|
0.43%
1/234 • Up to 52 weeks
|
0.00%
0/232 • Up to 52 weeks
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/234 • Up to 52 weeks
|
0.43%
1/232 • Up to 52 weeks
|
Other adverse events
| Measure |
RTX-GRT7039
n=234 participants at risk
Participants received intra-articular injections of RTX-GRT7039 (2 injections: Day 1 and Week 26) during the 52-week double-blind treatment period
|
Placebo
n=232 participants at risk
Participants received intra-articular injections of placebo matching to RTX-GRT7039 (2 injections: Day 1 and Week 26) during the 52-week double-blind treatment period.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Procedural pain
|
13.2%
31/234 • Up to 52 weeks
|
3.9%
9/232 • Up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
13/234 • Up to 52 weeks
|
8.6%
20/232 • Up to 52 weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
10/234 • Up to 52 weeks
|
5.2%
12/232 • 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