Trial Outcomes & Findings for Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus (NCT NCT02472795)
NCT ID: NCT02472795
Last Updated: 2025-10-03
Results Overview
The primary objective of the clinical study was to asses whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE). The change was defined as: Total lymphocyte count at end-of-treatment (EOT) minus total lymphocyte count at baseline. A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased. The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect. The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake. End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
105 participants
Primary outcome timeframe
Baseline to end-of-treatment (EOT) (up to 12 weeks)
Results posted on
2025-10-03
Participant Flow
This study was conducted at 18 sites in 6 countries between 1 June 2015 and 28 February 2017, 105 patients signed consent and 67 were randomized to a study treatment: 49 in part A (randomized 1:1:1:1 to receive cenerimod 0.5, 1, 2 mg or placebo) and 18 in part B (randomized 3:1 to receive cenerimod 4 mg or placebo).
The screening period started when the informed consent was signed (up to 30 days before randomization), and ended with randomization. The period included Visit 1 (screening) and the pre-randomization (pre-dose) assessments at Visit 2 (Day 1). Thirty-two patients did not meet the inclusion/exclusion criteria and 6 patients withdrew from the study.
Participant milestones
| Measure |
Cenerimod 0.5 mg (Part A)
Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.
|
Cenerimod 1 mg (Part A)
Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.
|
Cenerimod 2 mg (Part A)
Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.
|
Cenerimod 4 mg (Part B)
Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.
|
Matching Placebo (Part A and B)
Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
13
|
13
|
17
|
|
Overall Study
Pharmacodynamic Set
|
12
|
10
|
13
|
13
|
16
|
|
Overall Study
Modified Pharmacodynamic Analysis Set
|
12
|
10
|
13
|
9
|
16
|
|
Overall Study
COMPLETED
|
12
|
11
|
13
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Cenerimod 0.5 mg (Part A)
Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.
|
Cenerimod 1 mg (Part A)
Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.
|
Cenerimod 2 mg (Part A)
Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.
|
Cenerimod 4 mg (Part B)
Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.
|
Matching Placebo (Part A and B)
Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Different population analysis sets.
Baseline characteristics by cohort
| Measure |
Cenerimod 0.5 mg (Part A)
n=12 Participants
Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.
|
Cenerimod 1 mg (Part A)
n=12 Participants
Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.
|
Cenerimod 2 mg (Part A)
n=13 Participants
Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.
|
Cenerimod 4 mg (Part B)
n=13 Participants
Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.
|
Matching Placebo (Part A and Part B)
n=17 Participants
Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
Full analysis set
|
41.4 years
STANDARD_DEVIATION 13.2 • n=12 Participants • Different population analysis sets.
|
37.0 years
STANDARD_DEVIATION 6.4 • n=12 Participants • Different population analysis sets.
|
39.2 years
STANDARD_DEVIATION 11.8 • n=13 Participants • Different population analysis sets.
|
41.7 years
STANDARD_DEVIATION 8.1 • n=13 Participants • Different population analysis sets.
|
41.0 years
STANDARD_DEVIATION 9.5 • n=17 Participants • Different population analysis sets.
|
40.1 years
STANDARD_DEVIATION 9.9 • n=67 Participants • Different population analysis sets.
|
|
Age, Continuous
Pharmacodynamic analysis set
|
41.4 years
STANDARD_DEVIATION 13.2 • n=12 Participants • Different population analysis sets.
|
38.1 years
STANDARD_DEVIATION 5.4 • n=10 Participants • Different population analysis sets.
|
39.2 years
STANDARD_DEVIATION 11.8 • n=13 Participants • Different population analysis sets.
|
41.7 years
STANDARD_DEVIATION 8.1 • n=13 Participants • Different population analysis sets.
|
41.8 years
STANDARD_DEVIATION 9.2 • n=16 Participants • Different population analysis sets.
|
40.6 years
STANDARD_DEVIATION 9.8 • n=64 Participants • Different population analysis sets.
|
|
Age, Continuous
Modified pharmacodynamics analysis set
|
41.4 years
STANDARD_DEVIATION 13.2 • n=12 Participants • Different population analysis sets.
|
38.1 years
STANDARD_DEVIATION 5.4 • n=10 Participants • Different population analysis sets.
|
39.2 years
STANDARD_DEVIATION 11.8 • n=13 Participants • Different population analysis sets.
|
41.9 years
STANDARD_DEVIATION 8.6 • n=9 Participants • Different population analysis sets.
|
41.8 years
STANDARD_DEVIATION 9.2 • n=16 Participants • Different population analysis sets.
|
40.6 years
STANDARD_DEVIATION 9.9 • n=60 Participants • Different population analysis sets.
|
|
Sex: Female, Male
Full analysis set · Female
|
11 Participants
n=12 Participants • Different population analysis sets.
|
12 Participants
n=12 Participants • Different population analysis sets.
|
12 Participants
n=13 Participants • Different population analysis sets.
|
10 Participants
n=13 Participants • Different population analysis sets.
|
16 Participants
n=17 Participants • Different population analysis sets.
|
61 Participants
n=67 Participants • Different population analysis sets.
|
|
Sex: Female, Male
Full analysis set · Male
|
1 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=12 Participants • Different population analysis sets.
|
1 Participants
n=13 Participants • Different population analysis sets.
|
3 Participants
n=13 Participants • Different population analysis sets.
|
1 Participants
n=17 Participants • Different population analysis sets.
|
6 Participants
n=67 Participants • Different population analysis sets.
|
|
Sex: Female, Male
Pharmacodynamic analysis set · Female
|
11 Participants
n=12 Participants • Different population analysis sets.
|
10 Participants
n=10 Participants • Different population analysis sets.
|
12 Participants
n=13 Participants • Different population analysis sets.
|
10 Participants
n=13 Participants • Different population analysis sets.
|
16 Participants
n=16 Participants • Different population analysis sets.
|
59 Participants
n=64 Participants • Different population analysis sets.
|
|
Sex: Female, Male
Pharmacodynamic analysis set · Male
|
1 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=10 Participants • Different population analysis sets.
|
1 Participants
n=13 Participants • Different population analysis sets.
|
3 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=16 Participants • Different population analysis sets.
|
5 Participants
n=64 Participants • Different population analysis sets.
|
|
Sex: Female, Male
Modified pharmacodynamic analysis set · Female
|
11 Participants
n=12 Participants • Different population analysis sets.
|
10 Participants
n=10 Participants • Different population analysis sets.
|
12 Participants
n=13 Participants • Different population analysis sets.
|
7 Participants
n=9 Participants • Different population analysis sets.
|
16 Participants
n=16 Participants • Different population analysis sets.
|
56 Participants
n=60 Participants • Different population analysis sets.
|
|
Sex: Female, Male
Modified pharmacodynamic analysis set · Male
|
1 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=10 Participants • Different population analysis sets.
|
1 Participants
n=13 Participants • Different population analysis sets.
|
2 Participants
n=9 Participants • Different population analysis sets.
|
0 Participants
n=16 Participants • Different population analysis sets.
|
4 Participants
n=60 Participants • Different population analysis sets.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=67 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
13 Participants
n=13 Participants
|
13 Participants
n=13 Participants
|
17 Participants
n=17 Participants
|
67 Participants
n=67 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=67 Participants
|
|
Race (NIH/OMB)
Full analysis set · American Indian or Alaska Native
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=17 Participants • Different population analysis sets.
|
0 Participants
n=67 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Full analysis set · Asian
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=17 Participants • Different population analysis sets.
|
0 Participants
n=67 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Full analysis set · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=17 Participants • Different population analysis sets.
|
0 Participants
n=67 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Full analysis set · Black or African American
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
2 Participants
n=17 Participants • Different population analysis sets.
|
2 Participants
n=67 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Full analysis set · White
|
12 Participants
n=12 Participants • Different population analysis sets.
|
12 Participants
n=12 Participants • Different population analysis sets.
|
13 Participants
n=13 Participants • Different population analysis sets.
|
13 Participants
n=13 Participants • Different population analysis sets.
|
15 Participants
n=17 Participants • Different population analysis sets.
|
65 Participants
n=67 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Full analysis set · More than one race
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=17 Participants • Different population analysis sets.
|
0 Participants
n=67 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Full analysis set · Unknown or Not Reported
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=17 Participants • Different population analysis sets.
|
0 Participants
n=67 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Pharmacodynamic analysis set · American Indian or Alaska Native
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=10 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=16 Participants • Different population analysis sets.
|
0 Participants
n=64 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Pharmacodynamic analysis set · Asian
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=10 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=16 Participants • Different population analysis sets.
|
0 Participants
n=64 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Pharmacodynamic analysis set · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=10 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=16 Participants • Different population analysis sets.
|
0 Participants
n=64 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Pharmacodynamic analysis set · Black or African American
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=10 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
2 Participants
n=16 Participants • Different population analysis sets.
|
2 Participants
n=64 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Pharmacodynamic analysis set · White
|
12 Participants
n=12 Participants • Different population analysis sets.
|
10 Participants
n=10 Participants • Different population analysis sets.
|
13 Participants
n=13 Participants • Different population analysis sets.
|
13 Participants
n=13 Participants • Different population analysis sets.
|
14 Participants
n=16 Participants • Different population analysis sets.
|
62 Participants
n=64 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Pharmacodynamic analysis set · More than one race
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=10 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=16 Participants • Different population analysis sets.
|
0 Participants
n=64 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Pharmacodynamic analysis set · Unknown or Not Reported
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=10 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=16 Participants • Different population analysis sets.
|
0 Participants
n=64 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Modified pharmacodynamic analysis set · American Indian or Alaska Native
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=10 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=9 Participants • Different population analysis sets.
|
0 Participants
n=16 Participants • Different population analysis sets.
|
0 Participants
n=60 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Modified pharmacodynamic analysis set · Asian
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=10 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=9 Participants • Different population analysis sets.
|
0 Participants
n=16 Participants • Different population analysis sets.
|
0 Participants
n=60 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Modified pharmacodynamic analysis set · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=10 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=9 Participants • Different population analysis sets.
|
0 Participants
n=16 Participants • Different population analysis sets.
|
0 Participants
n=60 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Modified pharmacodynamic analysis set · Black or African American
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=10 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=9 Participants • Different population analysis sets.
|
2 Participants
n=16 Participants • Different population analysis sets.
|
2 Participants
n=60 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Modified pharmacodynamic analysis set · White
|
12 Participants
n=12 Participants • Different population analysis sets.
|
10 Participants
n=10 Participants • Different population analysis sets.
|
13 Participants
n=13 Participants • Different population analysis sets.
|
9 Participants
n=9 Participants • Different population analysis sets.
|
14 Participants
n=16 Participants • Different population analysis sets.
|
58 Participants
n=60 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Modified pharmacodynamic analysis set · More than one race
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=10 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=9 Participants • Different population analysis sets.
|
0 Participants
n=16 Participants • Different population analysis sets.
|
0 Participants
n=60 Participants • Different population analysis sets.
|
|
Race (NIH/OMB)
Modified pharmacodynamic analysis set · Unknown or Not Reported
|
0 Participants
n=12 Participants • Different population analysis sets.
|
0 Participants
n=10 Participants • Different population analysis sets.
|
0 Participants
n=13 Participants • Different population analysis sets.
|
0 Participants
n=9 Participants • Different population analysis sets.
|
0 Participants
n=16 Participants • Different population analysis sets.
|
0 Participants
n=60 Participants • Different population analysis sets.
|
|
Region of Enrollment
United States
|
1 participants
n=12 Participants
|
1 participants
n=12 Participants
|
0 participants
n=13 Participants
|
0 participants
n=13 Participants
|
2 participants
n=17 Participants
|
4 participants
n=67 Participants
|
|
Region of Enrollment
Ukraine
|
3 participants
n=12 Participants
|
1 participants
n=12 Participants
|
2 participants
n=13 Participants
|
1 participants
n=13 Participants
|
2 participants
n=17 Participants
|
9 participants
n=67 Participants
|
|
Region of Enrollment
Georgia
|
2 participants
n=12 Participants
|
1 participants
n=12 Participants
|
1 participants
n=13 Participants
|
1 participants
n=13 Participants
|
1 participants
n=17 Participants
|
6 participants
n=67 Participants
|
|
Region of Enrollment
Belarus
|
0 participants
n=12 Participants
|
1 participants
n=12 Participants
|
2 participants
n=13 Participants
|
2 participants
n=13 Participants
|
2 participants
n=17 Participants
|
7 participants
n=67 Participants
|
|
Region of Enrollment
Bulgaria
|
3 participants
n=12 Participants
|
2 participants
n=12 Participants
|
2 participants
n=13 Participants
|
7 participants
n=13 Participants
|
5 participants
n=17 Participants
|
19 participants
n=67 Participants
|
|
Region of Enrollment
Russia
|
3 participants
n=12 Participants
|
6 participants
n=12 Participants
|
6 participants
n=13 Participants
|
2 participants
n=13 Participants
|
5 participants
n=17 Participants
|
22 participants
n=67 Participants
|
|
Body mass index
Full analysis set
|
25.2 kg/m^2
STANDARD_DEVIATION 5.1 • n=12 Participants • Different population analysis sets.
|
27.4 kg/m^2
STANDARD_DEVIATION 8.0 • n=12 Participants • Different population analysis sets.
|
26.0 kg/m^2
STANDARD_DEVIATION 5.1 • n=13 Participants • Different population analysis sets.
|
27.5 kg/m^2
STANDARD_DEVIATION 4.7 • n=13 Participants • Different population analysis sets.
|
25.4 kg/m^2
STANDARD_DEVIATION 6.8 • n=17 Participants • Different population analysis sets.
|
26.3 kg/m^2
STANDARD_DEVIATION 6.0 • n=67 Participants • Different population analysis sets.
|
|
Body mass index
Pharmacodynamic analysis set
|
25.2 kg/m^2
STANDARD_DEVIATION 5.1 • n=12 Participants • Different population analysis sets.
|
28.8 kg/m^2
STANDARD_DEVIATION 8.1 • n=10 Participants • Different population analysis sets.
|
26.0 kg/m^2
STANDARD_DEVIATION 5.1 • n=13 Participants • Different population analysis sets.
|
27.5 kg/m^2
STANDARD_DEVIATION 4.7 • n=13 Participants • Different population analysis sets.
|
25.5 kg/m^2
STANDARD_DEVIATION 7.0 • n=16 Participants • Different population analysis sets.
|
26.5 kg/m^2
STANDARD_DEVIATION 6.1 • n=64 Participants • Different population analysis sets.
|
|
Body mass index
Modified pharmacodynamic analysis set
|
25.2 kg/m^2
STANDARD_DEVIATION 5.1 • n=12 Participants • Different population analysis sets.
|
28.8 kg/m^2
STANDARD_DEVIATION 8.1 • n=10 Participants • Different population analysis sets.
|
26.0 kg/m^2
STANDARD_DEVIATION 5.1 • n=13 Participants • Different population analysis sets.
|
28.3 kg/m^2
STANDARD_DEVIATION 5.4 • n=9 Participants • Different population analysis sets.
|
25.5 kg/m^2
STANDARD_DEVIATION 7.0 • n=16 Participants • Different population analysis sets.
|
26.5 kg/m^2
STANDARD_DEVIATION 6.2 • n=60 Participants • Different population analysis sets.
|
|
Disease history time from first Systemic Lupus Erythematosus symptoms
Full analysis set
|
3.7 years
n=12 Participants • Different population analysis sets.
|
8.2 years
n=12 Participants • Different population analysis sets.
|
6.7 years
n=13 Participants • Different population analysis sets.
|
4.6 years
n=13 Participants • Different population analysis sets.
|
7.9 years
n=17 Participants • Different population analysis sets.
|
6.0 years
n=67 Participants • Different population analysis sets.
|
|
Disease history time from first Systemic Lupus Erythematosus symptoms
Pharmacodynamic analysis set
|
3.7 years
n=12 Participants • Different population analysis sets.
|
9.2 years
n=10 Participants • Different population analysis sets.
|
6.7 years
n=13 Participants • Different population analysis sets.
|
4.6 years
n=13 Participants • Different population analysis sets.
|
7.9 years
n=16 Participants • Different population analysis sets.
|
6.2 years
n=64 Participants • Different population analysis sets.
|
|
Disease history time from first Systemic Lupus Erythematosus symptoms
Modified pharmacodynamic analysis set
|
3.7 years
n=12 Participants • Different population analysis sets.
|
9.2 years
n=10 Participants • Different population analysis sets.
|
6.7 years
n=13 Participants • Different population analysis sets.
|
3.2 years
n=9 Participants • Different population analysis sets.
|
7.9 years
n=16 Participants • Different population analysis sets.
|
6.2 years
n=60 Participants • Different population analysis sets.
|
|
Time from first Systemic Lupus Erythematosus diagnosis
Full analysis set
|
2.4 years
n=12 Participants • Different population analysis sets.
|
6.2 years
n=12 Participants • Different population analysis sets.
|
4.5 years
n=13 Participants • Different population analysis sets.
|
2.9 years
n=13 Participants • Different population analysis sets.
|
4.9 years
n=17 Participants • Different population analysis sets.
|
3.8 years
n=67 Participants • Different population analysis sets.
|
|
Time from first Systemic Lupus Erythematosus diagnosis
Pharmacodynamic analysis set
|
2.4 years
n=12 Participants • Different population analysis sets.
|
5.8 years
n=10 Participants • Different population analysis sets.
|
4.5 years
n=13 Participants • Different population analysis sets.
|
2.9 years
n=13 Participants • Different population analysis sets.
|
5.0 years
n=16 Participants • Different population analysis sets.
|
3.6 years
n=64 Participants • Different population analysis sets.
|
|
Time from first Systemic Lupus Erythematosus diagnosis
Modified pharmacodynamic analysis set
|
2.4 years
n=12 Participants • Different population analysis sets.
|
5.8 years
n=10 Participants • Different population analysis sets.
|
4.5 years
n=13 Participants • Different population analysis sets.
|
1.3 years
n=9 Participants • Different population analysis sets.
|
5.0 years
n=16 Participants • Different population analysis sets.
|
3.6 years
n=60 Participants • Different population analysis sets.
|
|
Number of American College of Rheumatology criteria ongoing at screening
0 to 3 ACR criteria ongoing at screening
|
5 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
5 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
6 Participants
n=17 Participants
|
20 Participants
n=67 Participants
|
|
Number of American College of Rheumatology criteria ongoing at screening
4 to 11 ACR criteria ongoing at screening
|
7 Participants
n=12 Participants
|
9 Participants
n=12 Participants
|
8 Participants
n=13 Participants
|
12 Participants
n=13 Participants
|
11 Participants
n=17 Participants
|
47 Participants
n=67 Participants
|
|
Number of American College of Rheumatology criteria ongoing at screening
0 to 3 ACR criteria more than 6 months ago
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=67 Participants
|
|
Number of American College of Rheumatology criteria ongoing at screening
4 to 11 ACR criteria more than 6 months ago
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
13 Participants
n=13 Participants
|
13 Participants
n=13 Participants
|
17 Participants
n=17 Participants
|
67 Participants
n=67 Participants
|
|
Systemic Lupus Erythematosus Disease Activity Index-2000, modified to exclude leucopenia
Full analysis set
|
7.3 units on a scale
STANDARD_DEVIATION 3.3 • n=12 Participants • Different population analysis sets.
|
8.3 units on a scale
STANDARD_DEVIATION 3.7 • n=12 Participants • Different population analysis sets.
|
7.1 units on a scale
STANDARD_DEVIATION 2.3 • n=13 Participants • Different population analysis sets.
|
8.7 units on a scale
STANDARD_DEVIATION 3.1 • n=13 Participants • Different population analysis sets.
|
7.4 units on a scale
STANDARD_DEVIATION 3.3 • n=17 Participants • Different population analysis sets.
|
7.7 units on a scale
STANDARD_DEVIATION 3.1 • n=67 Participants • Different population analysis sets.
|
|
Systemic Lupus Erythematosus Disease Activity Index-2000, modified to exclude leucopenia
Pharmacodynamic analysis set
|
7.3 units on a scale
STANDARD_DEVIATION 3.3 • n=12 Participants • Different population analysis sets.
|
7.0 units on a scale
STANDARD_DEVIATION 2.2 • n=10 Participants • Different population analysis sets.
|
7.1 units on a scale
STANDARD_DEVIATION 2.3 • n=13 Participants • Different population analysis sets.
|
8.7 units on a scale
STANDARD_DEVIATION 3.1 • n=13 Participants • Different population analysis sets.
|
7.3 units on a scale
STANDARD_DEVIATION 3.4 • n=16 Participants • Different population analysis sets.
|
7.5 units on a scale
STANDARD_DEVIATION 2.9 • n=64 Participants • Different population analysis sets.
|
|
Systemic Lupus Erythematosus Disease Activity Index-2000, modified to exclude leucopenia
Modified pharmacodynamic analysis set
|
7.3 units on a scale
STANDARD_DEVIATION 3.3 • n=12 Participants • Different population analysis sets.
|
7.0 units on a scale
STANDARD_DEVIATION 2.2 • n=10 Participants • Different population analysis sets.
|
7.1 units on a scale
STANDARD_DEVIATION 2.3 • n=13 Participants • Different population analysis sets.
|
8.1 units on a scale
STANDARD_DEVIATION 2.5 • n=9 Participants • Different population analysis sets.
|
7.3 units on a scale
STANDARD_DEVIATION 3.4 • n=16 Participants • Different population analysis sets.
|
7.3 units on a scale
STANDARD_DEVIATION 2.8 • n=60 Participants • Different population analysis sets.
|
PRIMARY outcome
Timeframe: Baseline to end-of-treatment (EOT) (up to 12 weeks)Population: Pharmacodynamics analysis (PD) set. The PD set includes all participants who received at least 21 days of study treatment, with lymphocyte count measurements at baseline and post-baseline. Last observation carried forward (using the Week 4 visit or later) was used for participants with a missing end-of-treatment (EOT) assessment.
The primary objective of the clinical study was to asses whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE). The change was defined as: Total lymphocyte count at end-of-treatment (EOT) minus total lymphocyte count at baseline. A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased. The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect. The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake. End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12.
Outcome measures
| Measure |
Cenerimod 0.5 mg (Part A)
n=12 Participants
Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.
|
Cenerimod 1 mg (Part A)
n=10 Participants
Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.
|
Cenerimod 2 mg (Part A)
n=13 Participants
Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.
|
Cenerimod 4 mg (Part B)
n=13 Participants
Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.
|
Matching Placebo
n=16 Participants
Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT)
|
-0.26 10^9 cells/L
Standard Deviation 0.48
|
-0.96 10^9 cells/L
Standard Deviation 0.68
|
-0.86 10^9 cells/L
Standard Deviation 0.61
|
-0.87 10^9 cells/L
Standard Deviation 1.24
|
-0.33 10^9 cells/L
Standard Deviation 0.72
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment Visit (up to 12 weeks)Population: Pharmacodynamics analysis (PD) set. The PD set includes all participants who received at least 21 days of study treatment, with lymphocyte count measurements at baseline and post-baseline. Last observation carried forward (using the Week 4 visit or later) was used for participants with a missing end-of-treatment (EOT) assessment.
The primary objective of the clinical study was to assess whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE). The change was defined as: Total lymphocyte count at visit minus total lymphocyte count at baseline. A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased. The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect. The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake. End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12.
Outcome measures
| Measure |
Cenerimod 0.5 mg (Part A)
n=12 Participants
Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.
|
Cenerimod 1 mg (Part A)
n=12 Participants
Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.
|
Cenerimod 2 mg (Part A)
n=13 Participants
Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.
|
Cenerimod 4 mg (Part B)
n=13 Participants
Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.
|
Matching Placebo
n=17 Participants
Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment
Baseline visit
|
1.37 10^9 cells/L
Standard Deviation 0.52
|
1.71 10^9 cells/L
Standard Deviation 0.82
|
1.62 10^9 cells/L
Standard Deviation 0.75
|
1.88 10^9 cells/L
Standard Deviation 0.77
|
1.65 10^9 cells/L
Standard Deviation 0.88
|
|
Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment
Week 2 visit
|
-0.13 10^9 cells/L
Standard Deviation 0.56
|
-0.48 10^9 cells/L
Standard Deviation 0.56
|
-0.52 10^9 cells/L
Standard Deviation 1.03
|
-1.09 10^9 cells/L
Standard Deviation 0.65
|
-0.16 10^9 cells/L
Standard Deviation 0.75
|
|
Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment
Week 4 visit
|
-0.28 10^9 cells/L
Standard Deviation 0.42
|
-0.69 10^9 cells/L
Standard Deviation 0.76
|
-0.86 10^9 cells/L
Standard Deviation 0.63
|
-0.68 10^9 cells/L
Standard Deviation 1.32
|
-0.33 10^9 cells/L
Standard Deviation 0.69
|
|
Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment
Week 8 Visit
|
-0.28 10^9 cells/L
Standard Deviation 0.60
|
-0.92 10^9 cells/L
Standard Deviation 0.60
|
-0.89 10^9 cells/L
Standard Deviation 0.68
|
-1.03 10^9 cells/L
Standard Deviation 1.12
|
-0.09 10^9 cells/L
Standard Deviation 0.82
|
|
Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment
Week 12 visit
|
-0.26 10^9 cells/L
Standard Deviation 0.48
|
-0.72 10^9 cells/L
Standard Deviation 1.03
|
-0.86 10^9 cells/L
Standard Deviation 0.61
|
-0.87 10^9 cells/L
Standard Deviation 1.24
|
-0.29 10^9 cells/L
Standard Deviation 0.73
|
|
Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment
End-of-treatment visit
|
-0.26 10^9 cells/L
Standard Deviation 0.48
|
-0.72 10^9 cells/L
Standard Deviation 1.03
|
-0.86 10^9 cells/L
Standard Deviation 0.61
|
-0.87 10^9 cells/L
Standard Deviation 1.24
|
-0.30 10^9 cells/L
Standard Deviation 0.71
|
POST_HOC outcome
Timeframe: Baseline to end-of-treatment (EOT) (up to 12 weeks)Population: Ctrough levels were discovered to be low, or below the lower limit of quantification (BLQ), in four patients randomized to the cenerimod 4 mg group, a finding incompatible with compliance with study treatment. These patients were excluded from the pharmacodynamic analysis set to form a modified pharmacodynamics analysis set.
The change was defined as: Total lymphocyte count at end-of-treatment (EOT) minus total lymphocyte count at baseline. A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased. The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake. End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12. The modified pharmacodynamics analysis set includes all participants who: * received at least 21 days of study treatment \& * with lymphocyte count measurements at baseline and post-baseline (namely, one sample taken at least 21 days after the first study treatment intake and no later than 7 days after the last study treatment intake with no treatment interruption documented in the first 21 days) \& * with cenerimod plasma concentrations at Week 4 consistent with expectations.
Outcome measures
| Measure |
Cenerimod 0.5 mg (Part A)
n=12 Participants
Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.
|
Cenerimod 1 mg (Part A)
n=10 Participants
Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.
|
Cenerimod 2 mg (Part A)
n=13 Participants
Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.
|
Cenerimod 4 mg (Part B)
n=9 Participants
Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.
|
Matching Placebo
n=16 Participants
Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT) Based on Pharmacokinetic Cthrough Profiles
|
-0.26 10^9 cells/L
Standard Deviation 0.48
|
-0.96 10^9 cells/L
Standard Deviation 0.68
|
-0.86 10^9 cells/L
Standard Deviation 0.61
|
-1.48 10^9 cells/L
Standard Deviation 0.73
|
-0.32 10^9 cells/L
Standard Deviation 0.72
|
POST_HOC outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment (EOT - up to 12 weeks), end-of-study (6 weeks after EOT)Population: All participants for which data was available. Ctrough levels were discovered to be low, or below the lower limit of quantification (BLQ), in four patients randomised to the cenerimod 4 mg group, a finding incompatible with compliance with study treatment. These patients were excluded from the PD set to form a modified pharmacodynamic analysis set.
The primary objective of the clinical study was to see whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE). The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect. The modified pharmacodynamics analysis set includes all participants who: * received at least 21 days of study treatment \& * with lymphocyte count measurements at baseline and post-baseline (namely, one sample taken at least 21 days after the first study treatment intake and no later than 7 days after the last study treatment intake with no treatment interruption documented in the first 21 days) \& * with cenerimod plasma concentrations at Week 4 consistent with expectations.
Outcome measures
| Measure |
Cenerimod 0.5 mg (Part A)
n=12 Participants
Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.
|
Cenerimod 1 mg (Part A)
n=10 Participants
Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.
|
Cenerimod 2 mg (Part A)
n=13 Participants
Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.
|
Cenerimod 4 mg (Part B)
n=9 Participants
Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.
|
Matching Placebo
n=16 Participants
Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Absolute Values of Total Lymphocyte Count at Each Analysis Visit
Baseline visit
|
1.37 10^9 cells/L
Standard Deviation 0.52
|
1.83 10^9 cells/L
Standard Deviation 0.79
|
1.62 10^9 cells/L
Standard Deviation 0.75
|
2.04 10^9 cells/L
Standard Deviation 0.80
|
1.66 10^9 cells/L
Standard Deviation 0.91
|
|
Absolute Values of Total Lymphocyte Count at Each Analysis Visit
Week 2 visit
|
1.24 10^9 cells/L
Standard Deviation 0.34
|
1.38 10^9 cells/L
Standard Deviation 0.49
|
1.19 10^9 cells/L
Standard Deviation 0.89
|
0.79 10^9 cells/L
Standard Deviation 0.44
|
1.44 10^9 cells/L
Standard Deviation 0.44
|
|
Absolute Values of Total Lymphocyte Count at Each Analysis Visit
Week 4 visit
|
1.09 10^9 cells/L
Standard Deviation 0.27
|
0.99 10^9 cells/L
Standard Deviation 0.38
|
0.73 10^9 cells/L
Standard Deviation 0.39
|
0.71 10^9 cells/L
Standard Deviation 0.49
|
1.31 10^9 cells/L
Standard Deviation 0.5
|
|
Absolute Values of Total Lymphocyte Count at Each Analysis Visit
Week 8 visit
|
1.08 10^9 cells/L
Standard Deviation 0.43
|
0.91 10^9 cells/L
Standard Deviation 0.40
|
0.73 10^9 cells/L
Standard Deviation 0.36
|
0.51 10^9 cells/L
Standard Deviation 0.28
|
1.49 10^9 cells/L
Standard Deviation 0.73
|
|
Absolute Values of Total Lymphocyte Count at Each Analysis Visit
Week 12 visit
|
1.11 10^9 cells/L
Standard Deviation 0.37
|
0.87 10^9 cells/L
Standard Deviation 0.34
|
0.76 10^9 cells/L
Standard Deviation 0.44
|
0.57 10^9 cells/L
Standard Deviation 0.21
|
1.33 10^9 cells/L
Standard Deviation 0.54
|
|
Absolute Values of Total Lymphocyte Count at Each Analysis Visit
End-of-treatment visit
|
1.11 10^9 cells/L
Standard Deviation 0.37
|
0.87 10^9 cells/L
Standard Deviation 0.34
|
0.76 10^9 cells/L
Standard Deviation 0.44
|
0.57 10^9 cells/L
Standard Deviation 0.21
|
1.34 10^9 cells/L
Standard Deviation 0.51
|
|
Absolute Values of Total Lymphocyte Count at Each Analysis Visit
End-of-study visit
|
1.42 10^9 cells/L
Standard Deviation 0.37
|
1.42 10^9 cells/L
Standard Deviation 0.58
|
1.35 10^9 cells/L
Standard Deviation 0.45
|
1.14 10^9 cells/L
Standard Deviation 0.52
|
1.71 10^9 cells/L
Standard Deviation 0.86
|
POST_HOC outcome
Timeframe: Baseline to End of Treatment (EOT) (up to 12 weeks)Population: Ctrough levels were discovered to be low, or below the lower limit of quantification (BLQ), in four patients randomized to the cenerimod 4 mg group, a finding incompatible with compliance with study treatment. These patients were excluded from the pharmacodynamic set to form a modified pharmacodynamic analysis set.
Percentage change in total lymphocyte count from baseline to end-of-treatment (EOT). Percent change from baseline is defined as the absolute change from baseline divided by the baseline value (if the baseline value is \> 0) and then multiplied by 100. A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased. The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect. The modified pharmacodynamics analysis set includes all participants who: * received at least 21 days of study treatment \& * with lymphocyte count measurements at baseline and post-baseline (namely, one sample taken at least 21 days after the first study treatment intake and no later than 7 days after the last study treatment intake with no treatment interruption documented in the first 21 days) \& * with cenerimod plasma concentrations at Week 4 consistent with expectations.
Outcome measures
| Measure |
Cenerimod 0.5 mg (Part A)
n=12 Participants
Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.
|
Cenerimod 1 mg (Part A)
n=10 Participants
Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.
|
Cenerimod 2 mg (Part A)
n=13 Participants
Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.
|
Cenerimod 4 mg (Part B)
n=9 Participants
Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.
|
Matching Placebo
n=16 Participants
Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Total Lymphocyte Count Percent Change From Baseline to End-of-treatment (EOT)
|
-12.23 Percent change of total lymphocyte count
Standard Deviation 34.29
|
-47.76 Percent change of total lymphocyte count
Standard Deviation 20.37
|
-51.52 Percent change of total lymphocyte count
Standard Deviation 22.53
|
-69.27 Percent change of total lymphocyte count
Standard Deviation 13.68
|
-5.04 Percent change of total lymphocyte count
Standard Deviation 39.22
|
Adverse Events
Cenerimod 0.5 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cenerimod 1 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cenerimod 2 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cenerimod 4 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cenerimod 0.5 mg
n=12 participants at risk
Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.
|
Cenerimod 1 mg
n=12 participants at risk
Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.
|
Cenerimod 2 mg
n=13 participants at risk
Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.
|
Cenerimod 4 mg
n=13 participants at risk
Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.
|
Matching Placebo
n=17 participants at risk
Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 2 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Hepatobiliary disorders
Post cholecystectomy syndrome
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
Other adverse events
| Measure |
Cenerimod 0.5 mg
n=12 participants at risk
Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.
|
Cenerimod 1 mg
n=12 participants at risk
Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.
|
Cenerimod 2 mg
n=13 participants at risk
Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.
|
Cenerimod 4 mg
n=13 participants at risk
Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.
|
Matching Placebo
n=17 participants at risk
Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Infections and infestations
Erysipelas
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
8.3%
1/12 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
2/12 • Number of events 2 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 2 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Eye disorders
Age-related macular degeneration
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Eye disorders
Cataract
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Eye disorders
Dry age-related macular degeneration
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.3%
1/12 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 2 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
8.3%
1/12 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
8.3%
1/12 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Hepatobiliary disorders
Chronic hepatitis
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
11.8%
2/17 • Number of events 2 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
8.3%
1/12 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
2/12 • Number of events 2 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Investigations
Bilirubin conjugated increased
|
8.3%
1/12 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Investigations
Electrocardiogram T wave amplitude decreased
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 2 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Investigations
Laboratory test abnormal
|
8.3%
1/12 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
8.3%
1/12 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Investigations
Neutrophil count decreased
|
8.3%
1/12 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 2 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
8.3%
1/12 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 2 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Renal and urinary disorders
Nitrituria
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Number of events 2 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
8.3%
1/12 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
5.9%
1/17 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
8.3%
1/12 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/12 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/13 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
7.7%
1/13 • Number of events 1 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
0.00%
0/17 • All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
|
Additional Information
Viatris Innovation Clinical Trial Information
Viatris Innovation GmbH
Phone: +1 908 435 2675
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place