Trial Outcomes & Findings for To Evaluate the Efficacy and Safety of Nemolizumab for 12 Weeks in Participants With Chronic Kidney Disease With Associated Moderate to Severe Pruritus (NCT NCT05075408)
NCT ID: NCT05075408
Last Updated: 2025-02-20
Results Overview
Responders are defined as participants with an improvement of \>= 4 in WI NRS from baseline at Week 12 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or Adverse event(AE)/death related to study drug. The WI NRS is a scale that is used by responders to report intensity of their worst pruritus (itch) during last 24 hours. Participants were asked following question: For worst itch intensity:"On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated worse outcome. Percentage of responders with an improvement of WI NRS \>= 4 from Baseline at Week 12 is reported here. Missing data due to discontinuation from the study prior to Week 12 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
258 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2025-02-20
Participant Flow
This study was conducted at 53 study sites in 4 countries from 18 March 2022 to 04 January 2024.
A total of 258 participants were enrolled and treated in this study.
Participant milestones
| Measure |
Nemolizumab 30 mg
Participants received a loading dose of 60 milligrams (mg) nemolizumab at Baseline followed by 2 subcutaneous (SC) injections for a total dose of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Nemolizumab 60 mg
Participants received 2 SC injections of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Placebo
Participants received 2 SC injections of 30 mg placebo-matched to nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
|---|---|---|---|
|
Overall Study
STARTED
|
88
|
85
|
85
|
|
Overall Study
COMPLETED
|
72
|
71
|
72
|
|
Overall Study
NOT COMPLETED
|
16
|
14
|
13
|
Reasons for withdrawal
| Measure |
Nemolizumab 30 mg
Participants received a loading dose of 60 milligrams (mg) nemolizumab at Baseline followed by 2 subcutaneous (SC) injections for a total dose of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Nemolizumab 60 mg
Participants received 2 SC injections of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Placebo
Participants received 2 SC injections of 30 mg placebo-matched to nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
4
|
|
Overall Study
Adverse Event
|
5
|
7
|
8
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Other-unspecified
|
3
|
2
|
0
|
Baseline Characteristics
To Evaluate the Efficacy and Safety of Nemolizumab for 12 Weeks in Participants With Chronic Kidney Disease With Associated Moderate to Severe Pruritus
Baseline characteristics by cohort
| Measure |
Nemolizumab 30 mg
n=88 Participants
Participants received a loading dose of 60 mg nemolizumab at Baseline followed by 2 SC injections for a total dose of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Nemolizumab 60 mg
n=85 Participants
Participants received 2 SC injections of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Placebo
n=85 Participants
Participants received 2 SC injections of 30 mg placebo-matched to nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Total
n=258 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 12.99 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 13.00 • n=7 Participants
|
58.4 years
STANDARD_DEVIATION 11.98 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 12.63 • n=4 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
145 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: ITT population consisted of all randomized participants.
Responders are defined as participants with an improvement of \>= 4 in WI NRS from baseline at Week 12 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or Adverse event(AE)/death related to study drug. The WI NRS is a scale that is used by responders to report intensity of their worst pruritus (itch) during last 24 hours. Participants were asked following question: For worst itch intensity:"On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated worse outcome. Percentage of responders with an improvement of WI NRS \>= 4 from Baseline at Week 12 is reported here. Missing data due to discontinuation from the study prior to Week 12 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae).
Outcome measures
| Measure |
Nemolizumab 30 mg
n=88 Participants
Participants received a loading dose of 60 mg nemolizumab at Baseline followed by 2 SC injections for a total dose of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Nemolizumab 60 mg
n=85 Participants
Participants received 2 SC injections of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Placebo
n=85 Participants
Participants received 2 SC injections of 30 mg placebo-matched to nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
|---|---|---|---|
|
Percentage of Responders With an Improvement of Worst Itch Numeric Rating Scale (WI NRS) Greater Than and Equal to (>=) 4 From Baseline at Week 12
|
38.5 Percentage of Participants
|
47.7 Percentage of Participants
|
32.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT population consisted of all randomized participants.
Responders are defined as participants with an improvement of \>= 3 in WI NRS from baseline at Week 12 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. The WI NRS is a scale that is used by the responders to report the intensity of their worst pruritus (itch) during the last 24 hours. Participants were asked the following question: For worst itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated worse outcome. Percentage of responders with an improvement of WI NRS \>= 3 from Baseline at Week 12 is reported here. Missing data due to discontinuation from the study prior to Week 12 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae).
Outcome measures
| Measure |
Nemolizumab 30 mg
n=88 Participants
Participants received a loading dose of 60 mg nemolizumab at Baseline followed by 2 SC injections for a total dose of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Nemolizumab 60 mg
n=85 Participants
Participants received 2 SC injections of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Placebo
n=85 Participants
Participants received 2 SC injections of 30 mg placebo-matched to nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
|---|---|---|---|
|
Percentage of Responders With an Improvement of WI NRS >= 3 From Baseline at Week 12
|
49.3 Percentage of Participants
|
60.6 Percentage of Participants
|
47.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: ITT population consisted of all randomized participants.
Responders are defined as participants with an improvement of \>= 4 in WI NRS from baseline at Week 4 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. The WI NRS is a scale that is used by the responders to report the intensity of their worst pruritus (itch) during the last 24 hours. Participants were asked the following question: For worst itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated worse outcome. Percentage of responders with an improvement of WI NRS \>= 4 from Baseline at Week 4 is reported here. Missing data due to discontinuation from the study prior to Week 4 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae).
Outcome measures
| Measure |
Nemolizumab 30 mg
n=88 Participants
Participants received a loading dose of 60 mg nemolizumab at Baseline followed by 2 SC injections for a total dose of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Nemolizumab 60 mg
n=85 Participants
Participants received 2 SC injections of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Placebo
n=85 Participants
Participants received 2 SC injections of 30 mg placebo-matched to nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
|---|---|---|---|
|
Percentage of Responders With an Improvement of WI NRS >= 4 From Baseline at Week 4
|
24.3 Percentage of Participants
|
26.6 Percentage of Participants
|
7.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT population consisted of all randomized participants.
Responders are participants with an improvement \>= 4 in SD NRS from baseline at Week 12 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. SD NRS is a scale used by participants to report degree of their sleep loss related to chronic kidney disease with associated pruritus (CKD-aP ). Participants were asked following question: "On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of pruritus' and 10 being 'I did not sleep at all due to the symptoms of pruritus', how would you rate your sleep last night?". Higher scores indicated worse outcome. Percentage of responders with an improvement of SD NRS \>= 4 from Baseline at Week 12 is reported here. Missing data due to discontinuation from study prior to Week 12 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae).
Outcome measures
| Measure |
Nemolizumab 30 mg
n=88 Participants
Participants received a loading dose of 60 mg nemolizumab at Baseline followed by 2 SC injections for a total dose of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Nemolizumab 60 mg
n=85 Participants
Participants received 2 SC injections of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Placebo
n=85 Participants
Participants received 2 SC injections of 30 mg placebo-matched to nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
|---|---|---|---|
|
Percentage of Responders With an Improvement of Sleep Disturbance Numerical Rating Scale (SD NRS) >= 4 From Baseline at Week 12
|
27.7 Percentage of Participants
|
42.6 Percentage of Participants
|
25.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: ITT population consisted of all randomized participants.
Responders are defined as participants with an improvement of \>= 3 in WI NRS from baseline at Week 4 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. The WI NRS is a scale that is used by the responders to report the intensity of their worst pruritus (itch) during the last 24 hours. Participants were asked the following question: For worst itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated worse outcome. Percentage of responders with an improvement of WI NRS \>= 3 from Baseline at Week 4 is reported here. Missing data due to discontinuation from the study prior to Week 4 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae).
Outcome measures
| Measure |
Nemolizumab 30 mg
n=88 Participants
Participants received a loading dose of 60 mg nemolizumab at Baseline followed by 2 SC injections for a total dose of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Nemolizumab 60 mg
n=85 Participants
Participants received 2 SC injections of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Placebo
n=85 Participants
Participants received 2 SC injections of 30 mg placebo-matched to nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
|---|---|---|---|
|
Percentage of Responders With an Improvement of WI NRS >= 3 From Baseline at Week 4
|
36.5 Percentage of Participants
|
35.0 Percentage of Participants
|
12.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: ITT population consisted of all randomized participants.
Responders are defined as participants with an improvement \>= 4 in SD NRS from baseline at Week 4 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. The SD NRS is a scale used by participants to report the degree of their sleep loss related to CKD-aP. Participants were asked the following question: "On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of pruritus' and 10 being 'I did not sleep at all due to the symptoms of pruritus', how would you rate your sleep last night?". Higher scores indicated worse outcome. Percentage of responders with an improvement of SD NRS \>= 4 from Baseline at Week 4 is reported here. Missing data due to discontinuation from the study prior to Week 4 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae).
Outcome measures
| Measure |
Nemolizumab 30 mg
n=88 Participants
Participants received a loading dose of 60 mg nemolizumab at Baseline followed by 2 SC injections for a total dose of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Nemolizumab 60 mg
n=85 Participants
Participants received 2 SC injections of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Placebo
n=85 Participants
Participants received 2 SC injections of 30 mg placebo-matched to nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
|---|---|---|---|
|
Percentage of Responders With an Improvement of SD NRS >= 4 From Baseline at Week 4
|
16.1 Percentage of Participants
|
23.6 Percentage of Participants
|
2.8 Percentage of Participants
|
Adverse Events
Nemolizumab 30 mg
Serious events: 33 serious events
Other events: 29 other events
Deaths: 4 deaths
Nemolizumab 60 mg
Serious events: 22 serious events
Other events: 25 other events
Deaths: 4 deaths
Placebo
Serious events: 27 serious events
Other events: 19 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Nemolizumab 30 mg
n=86 participants at risk
Participants received a loading dose of 60 mg nemolizumab at Baseline followed by 2 SC injections for a total dose of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Nemolizumab 60 mg
n=84 participants at risk
Participants received 2 SC injections of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Placebo
n=85 participants at risk
Participants received 2 SC injections of 30 mg placebo-matched to nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
|---|---|---|---|
|
Immune system disorders
Liver transplant rejection
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell papillary renal cell carcinoma
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
4.7%
4/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
3.5%
3/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Pneumonia
|
2.3%
2/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
5.9%
5/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Cellulitis
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Sepsis
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Bacterial myositis
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Candida pneumonia
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Chest wall abscess
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Gangrene
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Gastroenteritis
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Osteomyelitis
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Osteomyelitis acute
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Pulmonary sepsis
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Sinusitis bacterial
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Staphylococcal sepsis
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Urosepsis
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
4.7%
4/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Angina pectoris
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Atrioventricular block
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Coronary artery aneurysm
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Coronary artery dissection
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Pericardial effusion
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Pericarditis
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Tachycardia
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
2.3%
2/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula maturation failure
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site haemorrhage
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haematoma
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.5%
3/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.3%
2/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Umbilical hernia
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
General disorders
Asthenia
|
2.3%
2/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
General disorders
Non-cardiac chest pain
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
General disorders
Malaise
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Metabolic encephalopathy
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Syncope
|
2.3%
2/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Surgical and medical procedures
Renal transplant
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Surgical and medical procedures
Vascular access placement
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Vascular disorders
Aortic stenosis
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Vascular disorders
Hypertensive crisis
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Vascular disorders
Hypotension
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Immune system disorders
Kidney transplant rejection
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Triple negative breast cancer
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Cardiac arrest
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
3.5%
3/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Post cardiac arrest syndrome
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
Other adverse events
| Measure |
Nemolizumab 30 mg
n=86 participants at risk
Participants received a loading dose of 60 mg nemolizumab at Baseline followed by 2 SC injections for a total dose of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Nemolizumab 60 mg
n=84 participants at risk
Participants received 2 SC injections of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
Placebo
n=85 participants at risk
Participants received 2 SC injections of 30 mg placebo-matched to nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
2/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Pneumonia
|
2.3%
2/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Bronchitis
|
2.3%
2/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
2/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.3%
2/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.5%
3/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
4.8%
4/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
3.5%
3/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.3%
2/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
3/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
3.6%
3/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
3.5%
3/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
4.7%
4/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Toothache
|
2.3%
2/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
2/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
2.3%
2/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
3.5%
3/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
3.5%
3/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
3.5%
3/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.5%
3/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
3.6%
3/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
2/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.2%
1/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Vascular disorders
Dialysis hypotension
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
3.6%
3/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Vascular disorders
Hypotension
|
2.3%
2/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
3.5%
3/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.3%
2/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Dizziness
|
3.5%
3/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
1.2%
1/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/86 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
2.4%
2/84 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
0.00%
0/85 • From baseline up to Week 20
Safety population included all participants who received at least one dose of the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place