Trial Outcomes & Findings for A Proof-of-concept Study to Examine QUC398 in Participants With Knee OA (NCT NCT05462990)
NCT ID: NCT05462990
Last Updated: 2026-01-28
Results Overview
The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the pain frequency/severity during functional activities consisting of 9 questions with a recall of 7 days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change from baseline in KOOS pain score was analyzed using a mixed effects model for repeated measures (MMRM) including all time-points to compare treatment groups. The model includes baseline, treatment, timepoint and treatment-by-timepoints as fixed effects. Missing data is assumed to be Missing at Random (MAR). Based on a primary estimand framework.
TERMINATED
PHASE2
101 participants
Baseline, Week 12
2026-01-28
Participant Flow
Participants took part in 14 investigative sites in 6 countries.
The study consisted of a screening period of up to approximately 6 weeks.
Participant milestones
| Measure |
QUC398 300 mg
QUC398 was administered subcutaneous every 4 weeks during 48 weeks.
|
Placebo
Placebo was administered subcutaneous every 4 weeks during 48 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
24
|
25
|
Reasons for withdrawal
| Measure |
QUC398 300 mg
QUC398 was administered subcutaneous every 4 weeks during 48 weeks.
|
Placebo
Placebo was administered subcutaneous every 4 weeks during 48 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Protocol Deviation
|
3
|
1
|
|
Overall Study
Study Terminated By Sponsor
|
14
|
18
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
A Proof-of-concept Study to Examine QUC398 in Participants With Knee OA
Baseline characteristics by cohort
| Measure |
Placebo
n=51 Participants
Placebo was administered subcutaneous every 4 weeks during 48 weeks.
|
Total
n=101 Participants
Total of all reporting groups
|
QUC398 300 mg
n=50 Participants
QUC398 was administered subcutaneous every 4 weeks during 48 weeks.
|
|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 7.10 • n=157 Participants
|
64.1 years
STANDARD_DEVIATION 7.64 • n=315 Participants
|
65.9 years
STANDARD_DEVIATION 7.81 • n=158 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=157 Participants
|
58 Participants
n=315 Participants
|
28 Participants
n=158 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=157 Participants
|
43 Participants
n=315 Participants
|
22 Participants
n=158 Participants
|
|
Race/Ethnicity, Customized
White
|
49 Participants
n=157 Participants
|
97 Participants
n=315 Participants
|
48 Participants
n=158 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=157 Participants
|
3 Participants
n=315 Participants
|
2 Participants
n=158 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
0 Participants
n=158 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: The full analysis set (FAS) included all participants that received any study drug. Only participants with non-missing values were included in the analysis.
The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the pain frequency/severity during functional activities consisting of 9 questions with a recall of 7 days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change from baseline in KOOS pain score was analyzed using a mixed effects model for repeated measures (MMRM) including all time-points to compare treatment groups. The model includes baseline, treatment, timepoint and treatment-by-timepoints as fixed effects. Missing data is assumed to be Missing at Random (MAR). Based on a primary estimand framework.
Outcome measures
| Measure |
Placebo
n=43 Participants
Placebo was administered subcutaneous every 4 weeks during 48 weeks.
|
QUC398 300 mg
n=41 Participants
QUC398 was administered subcutaneous every 4 weeks during 48 weeks.
|
|---|---|---|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale at Week 12
|
17.5 score on scale
Standard Error 2.17
|
9.0 score on scale
Standard Error 2.25
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: The full analysis set (FAS) included all participants that received any study drug. Only participants with non-missing values were included in the analysis.
Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in volume of cartilage in the index region. The index region was defined as the union of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee. Change from baseline in cartilage volume was analyzed using a mixed effects model for repeated measures (MMRM) including all time-points to compare treatment groups. The model includes baseline, treatment, timepoint and treatment-timepoints as fixed effects, and participant as random effect. Missing data is assumed to be Missing at Random (MAR). Based on a secondary estimand framework.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo was administered subcutaneous every 4 weeks during 48 weeks.
|
QUC398 300 mg
n=24 Participants
QUC398 was administered subcutaneous every 4 weeks during 48 weeks.
|
|---|---|---|
|
Change From Baseline in Cartilage Volume of the Knee Index Region Measured by 3D-MRI
|
15.1 mm^3
Standard Error 47.42
|
47.8 mm^3
Standard Error 46.02
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 (Day 5), 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: The full analysis set (FAS) included all participants that received any study drug. At each time point, only participants with non-missing values were included in the analysis.
The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the pain frequency/severity during functional activities consisting of 9 questions with a recall of 7 days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. A positive change from baseline indicates an improvement. Change from baseline in KOOS pain score was analyzed using a mixed effects model for repeated measures (MMRM) including all time-points to compare treatment groups. The model includes baseline, treatment, timepoint and treatment-by-timepoints as fixed effects. Missing data is assumed to be Missing at Random (MAR). Based on second secondary estimand framework.
Outcome measures
| Measure |
Placebo
n=49 Participants
Placebo was administered subcutaneous every 4 weeks during 48 weeks.
|
QUC398 300 mg
n=45 Participants
QUC398 was administered subcutaneous every 4 weeks during 48 weeks.
|
|---|---|---|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
Week 20
|
18.1 score on scale
Standard Error 2.22
|
12.7 score on scale
Standard Error 2.3
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
Week 1 (Day 5)
|
5.0 score on scale
Standard Error 1.12
|
1.4 score on scale
Standard Error 1.17
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
Week 4
|
9.0 score on scale
Standard Error 1.67
|
3.9 score on scale
Standard Error 1.76
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
Week 8
|
14.1 score on scale
Standard Error 1.81
|
7.5 score on scale
Standard Error 1.88
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
Week 16
|
18.4 score on scale
Standard Error 2.28
|
11.8 score on scale
Standard Error 2.36
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
Week 24
|
19.1 score on scale
Standard Error 2.5
|
11.8 score on scale
Standard Error 2.62
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
Week 28
|
21.2 score on scale
Standard Error 2.51
|
12.6 score on scale
Standard Error 2.64
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
Week 32
|
20.4 score on scale
Standard Error 2.61
|
10.9 score on scale
Standard Error 2.77
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
Week 36
|
21.7 score on scale
Standard Error 2.62
|
11.3 score on scale
Standard Error 2.74
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
Week 40
|
20.0 score on scale
Standard Error 2.92
|
12.9 score on scale
Standard Error 2.98
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
Week 44
|
19.0 score on scale
Standard Error 3.26
|
14.2 score on scale
Standard Error 3.33
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
Week 48
|
21.4 score on scale
Standard Error 2.87
|
11.7 score on scale
Standard Error 2.93
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
Week 52
|
20.8 score on scale
Standard Error 2.93
|
11.7 score on scale
Standard Error 2.95
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: The full analysis set (FAS) included all participants that received any study drug. At each time point, only participants with non-missing values were included in the analysis.
The Numerical Rating Scale (NRS) Pain is a subjective assessment in which individuals rate their pain on an eleven-point numerical scale. NRS pain score ranges from 0-10 and for analyses were transformed to a 0-100 scale to be consistent with KOOS pain scores. A negative change from baseline implied improvement in pain. The NRS Pain instrument had a recall period of 24 hours and the participants were asked to rate the pain intensity at its worst. Change from baseline in NRS pain score was analyzed using a MMRM including all time-points to compare treatment groups. The model includes baseline, treatment, timepoint and treatment-by-timepoints as fixed effects. Missing data is assumed to be Missing at Random (MAR). Based on second secondary estimand framework.
Outcome measures
| Measure |
Placebo
n=49 Participants
Placebo was administered subcutaneous every 4 weeks during 48 weeks.
|
QUC398 300 mg
n=45 Participants
QUC398 was administered subcutaneous every 4 weeks during 48 weeks.
|
|---|---|---|
|
Change From Baseline in Pain Assessed by a Pain Numerical Rating Scale (NRS)
Week 1 (Day 5)
|
-3.1 score on scale
Standard Error 2.83
|
-2.6 score on scale
Standard Error 2.94
|
|
Change From Baseline in Pain Assessed by a Pain Numerical Rating Scale (NRS)
Week 4
|
-8.7 score on scale
Standard Error 2.84
|
-3.8 score on scale
Standard Error 2.97
|
|
Change From Baseline in Pain Assessed by a Pain Numerical Rating Scale (NRS)
Week 8
|
-12.5 score on scale
Standard Error 2.88
|
-7.5 score on scale
Standard Error 3.00
|
|
Change From Baseline in Pain Assessed by a Pain Numerical Rating Scale (NRS)
Week 12
|
-18.1 score on scale
Standard Error 2.89
|
-8.5 score on scale
Standard Error 2.98
|
|
Change From Baseline in Pain Assessed by a Pain Numerical Rating Scale (NRS)
Week 16
|
-19.4 score on scale
Standard Error 2.86
|
-12.8 score on scale
Standard Error 2.98
|
|
Change From Baseline in Pain Assessed by a Pain Numerical Rating Scale (NRS)
Week 20
|
-17.9 score on scale
Standard Error 2.89
|
-13.4 score on scale
Standard Error 3.01
|
|
Change From Baseline in Pain Assessed by a Pain Numerical Rating Scale (NRS)
Week 24
|
-19.0 score on scale
Standard Error 2.90
|
-10.7 score on scale
Standard Error 3.07
|
|
Change From Baseline in Pain Assessed by a Pain Numerical Rating Scale (NRS)
Week 28
|
-23.5 score on scale
Standard Error 2.92
|
-13.1 score on scale
Standard Error 3.10
|
|
Change From Baseline in Pain Assessed by a Pain Numerical Rating Scale (NRS)
Week 32
|
-21.0 score on scale
Standard Error 2.95
|
-13.6 score on scale
Standard Error 3.14
|
|
Change From Baseline in Pain Assessed by a Pain Numerical Rating Scale (NRS)
Week 36
|
-23.5 score on scale
Standard Error 3.06
|
-15.7 score on scale
Standard Error 3.22
|
|
Change From Baseline in Pain Assessed by a Pain Numerical Rating Scale (NRS)
Week 40
|
-23.7 score on scale
Standard Error 3.28
|
-16.4 score on scale
Standard Error 3.36
|
|
Change From Baseline in Pain Assessed by a Pain Numerical Rating Scale (NRS)
Week 44
|
-21.3 score on scale
Standard Error 3.40
|
-16.6 score on scale
Standard Error 3.48
|
|
Change From Baseline in Pain Assessed by a Pain Numerical Rating Scale (NRS)
Week 48
|
-25.7 score on scale
Standard Error 3.59
|
-15.6 score on scale
Standard Error 3.63
|
|
Change From Baseline in Pain Assessed by a Pain Numerical Rating Scale (NRS)
Week 52
|
-25.4 score on scale
Standard Error 3.65
|
-16.7 score on scale
Standard Error 3.61
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: The full analysis set (FAS) included all participants that received any study drug. At each time point, only participants with non-missing values were included in the analysis.
The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems.The original KOOS consists of 5 subscales: Pain, other Symptoms (like stiffness and swelling), Function in Daily Living, Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Total KOOS scale was calculated as the average of all subscales (100 indicating no symptoms and 0 indicating extreme symptoms). A positive change from baseline indicates an improvement. Change from baseline in KOOS total score was analyzed using a mixed effects model for repeated measures (MMRM) including all time-points to compare treatment groups. The model includes baseline, treatment, timepoint and treatment-by-timepoints as fixed effects. Missing data is assumed to be Missing at Random (MAR). Based on second secondary estimand framework.
Outcome measures
| Measure |
Placebo
n=49 Participants
Placebo was administered subcutaneous every 4 weeks during 48 weeks.
|
QUC398 300 mg
n=45 Participants
QUC398 was administered subcutaneous every 4 weeks during 48 weeks.
|
|---|---|---|
|
Change From Baseline in Total Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 1 (Day 5)
|
4.2 score on scale
Standard Error 1.99
|
1.4 score on scale
Standard Error 2.07
|
|
Change From Baseline in Total Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 4
|
8.4 score on scale
Standard Error 1.99
|
3.3 score on scale
Standard Error 2.08
|
|
Change From Baseline in Total Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 8
|
12.5 score on scale
Standard Error 2.02
|
6.7 score on scale
Standard Error 2.10
|
|
Change From Baseline in Total Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 12
|
15.9 score on scale
Standard Error 2.02
|
8.6 score on scale
Standard Error 2.09
|
|
Change From Baseline in Total Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 16
|
16.5 score on scale
Standard Error 2.01
|
10.8 score on scale
Standard Error 2.09
|
|
Change From Baseline in Total Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 20
|
16.2 score on scale
Standard Error 2.02
|
11.2 score on scale
Standard Error 2.11
|
|
Change From Baseline in Total Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 24
|
17.9 score on scale
Standard Error 2.03
|
10.6 score on scale
Standard Error 2.13
|
|
Change From Baseline in Total Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 28
|
19.2 score on scale
Standard Error 2.04
|
11.1 score on scale
Standard Error 2.16
|
|
Change From Baseline in Total Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 32
|
18.4 score on scale
Standard Error 2.05
|
11.1 score on scale
Standard Error 2.18
|
|
Change From Baseline in Total Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 36
|
20.1 score on scale
Standard Error 2.12
|
11.6 score on scale
Standard Error 2.23
|
|
Change From Baseline in Total Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 40
|
19.6 score on scale
Standard Error 2.24
|
12.7 score on scale
Standard Error 2.30
|
|
Change From Baseline in Total Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 44
|
18.4 score on scale
Standard Error 2.32
|
12.9 score on scale
Standard Error 2.38
|
|
Change From Baseline in Total Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 48
|
22.6 score on scale
Standard Error 2.46
|
12.5 score on scale
Standard Error 2.49
|
|
Change From Baseline in Total Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 52
|
21.0 score on scale
Standard Error 2.51
|
13.7 score on scale
Standard Error 2.49
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: The full analysis set (FAS) included all participants that received any study drug. At each time point, only participants with non-missing values were included in the analysis.
The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is other symptoms (eg., stiffness, swelling, clicking) consisting of 7 questions with a recall of 7 days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. A positive change from baseline indicates an improvement. Change from baseline in KOOS Other symptoms score was analyzed using a mixed effects model for repeated measures (MMRM) including all time-points to compare treatment groups. The model includes baseline, treatment, timepoint and treatment-by-timepoints as fixed effects. Missing data is assumed to be Missing at Random (MAR). Based on second secondary estimand framework.
Outcome measures
| Measure |
Placebo
n=49 Participants
Placebo was administered subcutaneous every 4 weeks during 48 weeks.
|
QUC398 300 mg
n=45 Participants
QUC398 was administered subcutaneous every 4 weeks during 48 weeks.
|
|---|---|---|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Other Symptoms Subscale
Week 1 (Day 5)
|
4 score on scale
Standard Error 2.14
|
0.3 score on scale
Standard Error 2.23
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Other Symptoms Subscale
Week 4
|
8.8 score on scale
Standard Error 2.15
|
2.5 score on scale
Standard Error 2.24
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Other Symptoms Subscale
Week 8
|
12.3 score on scale
Standard Error 2.17
|
3.2 score on scale
Standard Error 2.26
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Other Symptoms Subscale
Week 12
|
14.3 score on scale
Standard Error 2.18
|
6.6 score on scale
Standard Error 2.24
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Other Symptoms Subscale
Week 16
|
15.5 score on scale
Standard Error 2.16
|
9.2 score on scale
Standard Error 2.24
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Other Symptoms Subscale
Week 20
|
13.4 score on scale
Standard Error 2.18
|
8.7 score on scale
Standard Error 2.27
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Other Symptoms Subscale
Week 24
|
14.6 score on scale
Standard Error 2.18
|
7.7 score on scale
Standard Error 2.3
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Other Symptoms Subscale
Week 28
|
17.7 score on scale
Standard Error 2.2
|
7.6 score on scale
Standard Error 2.32
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Other Symptoms Subscale
Week 32
|
15.7 score on scale
Standard Error 2.2
|
7.4 score on scale
Standard Error 2.35
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Other Symptoms Subscale
Week 36
|
18.3 score on scale
Standard Error 2.28
|
8.2 score on scale
Standard Error 2.4
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Other Symptoms Subscale
Week 40
|
16.9 score on scale
Standard Error 2.43
|
10.4 score on scale
Standard Error 2.48
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Other Symptoms Subscale
Week 44
|
14.1 score on scale
Standard Error 2.51
|
11.1 score on scale
Standard Error 2.57
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Other Symptoms Subscale
Week 48
|
18.6 score on scale
Standard Error 2.65
|
9.5 score on scale
Standard Error 2.68
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Other Symptoms Subscale
Week 52
|
18.1 score on scale
Standard Error 2.7
|
11.1 score on scale
Standard Error 2.68
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: The full analysis set (FAS) included all participants that received any study drug. At each time point, only participants with non-missing values were included in the analysis.
The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the Function in Daily Living consisting of 17 questions with a recall of 7 days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. A positive change from baseline indicates an improvement. Change from baseline in KOOS Function in daily living score was analyzed using a mixed effects model for repeated measures (MMRM) including all time-points to compare treatment groups. The model includes baseline, treatment, timepoint and treatment-by-timepoints as fixed effects. Missing data is assumed to be Missing at Random (MAR). Based on second secondary estimand framework.
Outcome measures
| Measure |
Placebo
n=49 Participants
Placebo was administered subcutaneous every 4 weeks during 48 weeks.
|
QUC398 300 mg
n=45 Participants
QUC398 was administered subcutaneous every 4 weeks during 48 weeks.
|
|---|---|---|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living Subscale
Week 4
|
10.5 score on scale
Standard Error 2.23
|
3.5 score on scale
Standard Error 2.33
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living Subscale
Week 20
|
20.6 score on scale
Standard Error 2.27
|
15.0 score on scale
Standard Error 2.36
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living Subscale
Week 1 (Day 5)
|
4.4 score on scale
Standard Error 2.22
|
2.9 score on scale
Standard Error 2.32
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living Subscale
Week 8
|
16.4 score on scale
Standard Error 2.26
|
9.4 score on scale
Standard Error 2.35
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living Subscale
Week 12
|
19.1 score on scale
Standard Error 2.26
|
11.3 score on scale
Standard Error 2.34
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living Subscale
Week 16
|
20.5 score on scale
Standard Error 2.25
|
12.5 score on scale
Standard Error 2.34
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living Subscale
Week 24
|
20.6 score on scale
Standard Error 2.28
|
13.5 score on scale
Standard Error 2.4
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living Subscale
Week 28
|
21.9 score on scale
Standard Error 2.29
|
13.1 score on scale
Standard Error 2.43
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living Subscale
Week 32
|
21.7 score on scale
Standard Error 2.3
|
13.4 score on scale
Standard Error 2.46
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living Subscale
Week 36
|
23.2 score on scale
Standard Error 2.39
|
14.3 score on scale
Standard Error 2.52
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living Subscale
Week 40
|
22.5 score on scale
Standard Error 2.55
|
17.0 score on scale
Standard Error 2.62
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living Subscale
Week 44
|
19.7 score on scale
Standard Error 2.66
|
16.3 score on scale
Standard Error 2.72
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living Subscale
Week 48
|
25.4 score on scale
Standard Error 2.83
|
15.8 score on scale
Standard Error 2.85
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living Subscale
Week 52
|
24.2 score on scale
Standard Error 2.91
|
16.4 score on scale
Standard Error 2.87
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: The full analysis set (FAS) included all participants that received any study drug. At each time point, only participants with non-missing values were included in the analysis.
The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the function in sport and recreation consisting of 5 questions with a recall of 7 days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. A positive change from baseline indicates an improvement. Change from baseline in KOOS Function in sport and recreation score was analyzed using a mixed effects model for repeated measures (MMRM) including all time-points to compare treatment groups. The model includes baseline, treatment, timepoint and treatment-by-timepoints as fixed effects. Missing data is assumed to be Missing at Random (MAR). Based on second secondary estimand framework.
Outcome measures
| Measure |
Placebo
n=49 Participants
Placebo was administered subcutaneous every 4 weeks during 48 weeks.
|
QUC398 300 mg
n=45 Participants
QUC398 was administered subcutaneous every 4 weeks during 48 weeks.
|
|---|---|---|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation Subscale
Week 52
|
23.2 score on scale
Standard Error 3.47
|
14.7 score on scale
Standard Error 3.42
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation Subscale
Week 1 (Day 5)
|
2.5 score on scale
Standard Error 2.65
|
2.1 score on scale
Standard Error 2.76
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation Subscale
Week 4
|
7.5 score on scale
Standard Error 2.65
|
4.5 score on scale
Standard Error 2.78
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation Subscale
Week 8
|
11.5 score on scale
Standard Error 2.7
|
8.7 score on scale
Standard Error 2.81
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation Subscale
Week 12
|
17.3 score on scale
Standard Error 2.7
|
10.1 score on scale
Standard Error 2.79
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation Subscale
Week 16
|
15.8 score on scale
Standard Error 2.67
|
12.0 score on scale
Standard Error 2.79
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation Subscale
Week 20
|
16.7 score on scale
Standard Error 2.7
|
11.1 score on scale
Standard Error 2.82
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation Subscale
Week 24
|
22.0 score on scale
Standard Error 2.71
|
12.6 score on scale
Standard Error 2.87
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation Subscale
Week 28
|
19.4 score on scale
Standard Error 2.73
|
12.2 score on scale
Standard Error 2.9
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation Subscale
Week 32
|
21.2 score on scale
Standard Error 2.74
|
14.2 score on scale
Standard Error 2.93
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation Subscale
Week 36
|
22.1 score on scale
Standard Error 2.86
|
14.6 score on scale
Standard Error 3.00
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation Subscale
Week 40
|
19.8 score on scale
Standard Error 3.06
|
12.4 score on scale
Standard Error 3.13
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation Subscale
Week 44
|
22.5 score on scale
Standard Error 3.17
|
14.4 score on scale
Standard Error 3.25
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation Subscale
Week 48
|
24.1 score on scale
Standard Error 3.36
|
12.9 score on scale
Standard Error 3.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: The full analysis set (FAS) included all participants that received any study drug. At each time point, only participants with non-missing values were included in the analysis.
The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the knee-related quality of life consisting of 4 questions with a recall of 7 days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. A positive change from baseline indicates an improvement. Change from baseline in KOOS Knee related quality of life score was analyzed using a mixed effects model for repeated measures (MMRM) including all time-points to compare treatment groups. The model includes baseline, treatment, timepoint and treatment-by-timepoints as fixed effects. Missing data is assumed to be Missing at Random (MAR). Based on second secondary estimand framework.
Outcome measures
| Measure |
Placebo
n=49 Participants
Placebo was administered subcutaneous every 4 weeks during 48 weeks.
|
QUC398 300 mg
n=45 Participants
QUC398 was administered subcutaneous every 4 weeks during 48 weeks.
|
|---|---|---|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Related Quality of Life Subscale
Week 1 (Day 5)
|
5.2 score on scale
Standard Error 2.2
|
0.4 score on scale
Standard Error 2.28
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Related Quality of Life Subscale
Week 4
|
5.7 score on scale
Standard Error 2.21
|
2.2 score on scale
Standard Error 2.3
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Related Quality of Life Subscale
Week 8
|
8.6 score on scale
Standard Error 2.24
|
5.3 score on scale
Standard Error 2.32
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Related Quality of Life Subscale
Week 12
|
11.5 score on scale
Standard Error 2.24
|
5.5 score on scale
Standard Error 2.31
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Related Quality of Life Subscale
Week 16
|
12.9 score on scale
Standard Error 2.22
|
8.6 score on scale
Standard Error 2.31
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Related Quality of Life Subscale
Week 20
|
12.3 score on scale
Standard Error 2.24
|
8.4 score on scale
Standard Error 2.33
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Related Quality of Life Subscale
Week 24
|
13.4 score on scale
Standard Error 2.25
|
7.1 score on scale
Standard Error 2.37
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Related Quality of Life Subscale
Week 28
|
16.3 score on scale
Standard Error 2.27
|
9.8 score on scale
Standard Error 2.39
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Related Quality of Life Subscale
Week 32
|
13.1 score on scale
Standard Error 2.28
|
9.5 score on scale
Standard Error 2.42
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Related Quality of Life Subscale
Week 36
|
15.8 score on scale
Standard Error 2.36
|
9.4 score on scale
Standard Error 2.48
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Related Quality of Life Subscale
Week 40
|
17.4 score on scale
Standard Error 2.52
|
10.4 score on scale
Standard Error 2.58
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Related Quality of Life Subscale
Week 44
|
16.7 score on scale
Standard Error 2.62
|
9.5 score on scale
Standard Error 2.68
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Related Quality of Life Subscale
Week 48
|
19.5 score on scale
Standard Error 2.77
|
11.1 score on scale
Standard Error 2.8
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Related Quality of Life Subscale
Week 52
|
17.6 score on scale
Standard Error 2.81
|
13.1 score on scale
Standard Error 2.79
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: The full analysis set (FAS) included all participants that received any study drug. At each time point, only participants with non-missing values were included in the analysis.
The PGA of osteoarthritis disease activity was performed using a NRS (11-point scale from 0 - 10) with a recall period of 24 hours, and it was completed by the participant prior to drug administration at visits specified in the assessment schedule. A negative change from baseline implied improvement in pain. Change from baseline in function in patients global assessment (PGA) was analyzed using a MMRM including all time-points to compare treatment group. The model included baseline, treatment, timepoint and treatment-by-timepoints as fixed effects. Missing data is assumed to be Missing At Random (MAR). Based on second secondary estimand framework.
Outcome measures
| Measure |
Placebo
n=49 Participants
Placebo was administered subcutaneous every 4 weeks during 48 weeks.
|
QUC398 300 mg
n=45 Participants
QUC398 was administered subcutaneous every 4 weeks during 48 weeks.
|
|---|---|---|
|
Change From Baseline in Patient's Global Assessment (PGA) as Assessed by NRS
Week 52
|
-2.0 score on scale
Standard Error 0.47
|
-1.5 score on scale
Standard Error 0.47
|
|
Change From Baseline in Patient's Global Assessment (PGA) as Assessed by NRS
Week 8
|
-1.2 score on scale
Standard Error 0.21
|
-0.7 score on scale
Standard Error 0.22
|
|
Change From Baseline in Patient's Global Assessment (PGA) as Assessed by NRS
Week 12
|
-1.4 score on scale
Standard Error 0.26
|
-1.0 score on scale
Standard Error 0.27
|
|
Change From Baseline in Patient's Global Assessment (PGA) as Assessed by NRS
Week 16
|
-1.6 score on scale
Standard Error 0.26
|
-1.0 score on scale
Standard Error 0.27
|
|
Change From Baseline in Patient's Global Assessment (PGA) as Assessed by NRS
Week 20
|
-1.7 score on scale
Standard Error 0.29
|
-1.0 score on scale
Standard Error 0.30
|
|
Change From Baseline in Patient's Global Assessment (PGA) as Assessed by NRS
Week 24
|
-1.8 score on scale
Standard Error 0.3
|
-1.2 score on scale
Standard Error 0.32
|
|
Change From Baseline in Patient's Global Assessment (PGA) as Assessed by NRS
Week 1 (Day 5)
|
-0.4 score on scale
Standard Error 0.13
|
-0.1 score on scale
Standard Error 0.14
|
|
Change From Baseline in Patient's Global Assessment (PGA) as Assessed by NRS
Week 4
|
-0.8 score on scale
Standard Error 0.19
|
-0.3 score on scale
Standard Error 0.2
|
|
Change From Baseline in Patient's Global Assessment (PGA) as Assessed by NRS
Week 28
|
-2.1 score on scale
Standard Error 0.31
|
-1.3 score on scale
Standard Error 0.33
|
|
Change From Baseline in Patient's Global Assessment (PGA) as Assessed by NRS
Week 32
|
-2.0 score on scale
Standard Error 0.33
|
-1.3 score on scale
Standard Error 0.35
|
|
Change From Baseline in Patient's Global Assessment (PGA) as Assessed by NRS
Week 36
|
-2.3 score on scale
Standard Error 0.31
|
-1.3 score on scale
Standard Error 0.33
|
|
Change From Baseline in Patient's Global Assessment (PGA) as Assessed by NRS
Week 40
|
-2.1 score on scale
Standard Error 0.38
|
-1.4 score on scale
Standard Error 0.39
|
|
Change From Baseline in Patient's Global Assessment (PGA) as Assessed by NRS
Week 44
|
-2.2 score on scale
Standard Error 0.37
|
-1.5 score on scale
Standard Error 0.38
|
|
Change From Baseline in Patient's Global Assessment (PGA) as Assessed by NRS
Week 48
|
-2.3 score on scale
Standard Error 0.41
|
-1.3 score on scale
Standard Error 0.42
|
Adverse Events
QUC398 300 mg
Placebo
Total
Serious adverse events
| Measure |
QUC398 300 mg
n=50 participants at risk
QUC398 was administered subcutaneous every 4 weeks during 48 weeks.
|
Placebo
n=51 participants at risk
Placebo was administered subcutaneous every 4 weeks during 48 weeks.
|
Total
n=101 participants at risk
Total
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
2.0%
1/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
2.0%
1/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
General disorders
Chest pain
|
0.00%
0/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
2.0%
1/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
2.0%
1/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
2.0%
1/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
2.0%
1/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
0.00%
0/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
2.0%
1/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
0.00%
0/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
Other adverse events
| Measure |
QUC398 300 mg
n=50 participants at risk
QUC398 was administered subcutaneous every 4 weeks during 48 weeks.
|
Placebo
n=51 participants at risk
Placebo was administered subcutaneous every 4 weeks during 48 weeks.
|
Total
n=101 participants at risk
Total
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
5.9%
3/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
3.0%
3/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
General disorders
Influenza like illness
|
16.0%
8/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
7.8%
4/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
11.9%
12/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
General disorders
Injection site reaction
|
46.0%
23/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
9.8%
5/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
27.7%
28/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Infections and infestations
COVID-19
|
8.0%
4/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
3.9%
2/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
5.9%
6/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Infections and infestations
Influenza
|
12.0%
6/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
19.6%
10/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
15.8%
16/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
14.0%
7/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
21.6%
11/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
17.8%
18/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
5.9%
3/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
4.0%
4/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
5.9%
3/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
4.0%
4/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
5.9%
3/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
3.0%
3/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
5.9%
3/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
3.0%
3/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
6.0%
3/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
0.00%
0/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
3.0%
3/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
3/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
19.6%
10/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
12.9%
13/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.0%
3/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
3.9%
2/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
5.0%
5/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
5/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
0.00%
0/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
5.0%
5/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
20.0%
10/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
3.9%
2/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
11.9%
12/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
5.9%
3/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
4.0%
4/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
6.0%
3/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
0.00%
0/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
3.0%
3/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Nervous system disorders
Headache
|
8.0%
4/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
5.9%
3/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
6.9%
7/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
2/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
7.8%
4/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
5.9%
6/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.0%
3/50 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
3.9%
2/51 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
5.0%
5/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 60 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER