Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis Patients (NCT NCT03948334)
NCT ID: NCT03948334
Last Updated: 2021-10-08
Results Overview
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. As all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
16 weeks (week 16 to week 32 referring to core study)
Results posted on
2021-10-08
Participant Flow
Subjects who had received ZPL389 30 mg or 50 mg doses in the core study, continued to receive the same doses in double-blinded fashion. Subjects who had received ZPL389 3 mg, 10 mg or placebo in the core study were randomized to 30 mg or 50 mg ZPL389 in a 1:1 ratio.
Participant milestones
| Measure |
ZPL389 30mg
Dose 1 of ZPL389 + TCS and/or TCI
|
ZPL389 50mg
Dose 2 of ZPL389 + TCS and/or TCI
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
63
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
60
|
63
|
Reasons for withdrawal
| Measure |
ZPL389 30mg
Dose 1 of ZPL389 + TCS and/or TCI
|
ZPL389 50mg
Dose 2 of ZPL389 + TCS and/or TCI
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
4
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
|
Overall Study
Study terminated by Sponsor
|
50
|
51
|
|
Overall Study
Subject Decision /Guardian Decision
|
4
|
7
|
Baseline Characteristics
A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis Patients
Baseline characteristics by cohort
| Measure |
ZPL389 30mg
n=60 Participants
Dose 1 of ZPL389 + TCS and/or TCI
|
ZPL389 50mg
n=63 Participants
Dose 2 of ZPL389 + TCS and/or TCI
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.8 years
STANDARD_DEVIATION 12.18 • n=5 Participants
|
34.4 years
STANDARD_DEVIATION 11.24 • n=7 Participants
|
34.6 years
STANDARD_DEVIATION 11.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
36 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeks (week 16 to week 32 referring to core study)Population: The Extension study set comprised all subjects who were randomized and to whom study treatment had been assigned and had at least one visit in the extension study.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. As all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis.
Outcome measures
| Measure |
ZPL389 30mg
n=60 Participants
Dose 1 of ZPL389 + TCS and/or TCI
|
ZPL389 50mg
n=63 Participants
Dose 2 of ZPL389 + TCS and/or TCI
|
ZPL389 30mg Continuing After Core Study
30mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study
|
ZPL389 50mg Continuing After Core Study
50mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study
|
|---|---|---|---|---|
|
Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study
Adverse events
|
29 Participants
|
33 Participants
|
—
|
—
|
|
Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study
SAEs
|
2 Participants
|
5 Participants
|
—
|
—
|
|
Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study
AEs leading to discontinuation
|
2 Participants
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From week 16 to week 67 of this extension study (week 32 to week 83 referring to core study)Population: The Extension study set comprised all subjects who were randomized and to whom study treatment had been assigned and had at least one visit in the extension study.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. As all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis.
Outcome measures
| Measure |
ZPL389 30mg
n=60 Participants
Dose 1 of ZPL389 + TCS and/or TCI
|
ZPL389 50mg
n=63 Participants
Dose 2 of ZPL389 + TCS and/or TCI
|
ZPL389 30mg Continuing After Core Study
30mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study
|
ZPL389 50mg Continuing After Core Study
50mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study
|
|---|---|---|---|---|
|
Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study
Adverse events
|
18 Participants
|
20 Participants
|
—
|
—
|
|
Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study
SAEs
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study
AEs leading to discontinuation
|
0 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 16, Week 28, Week 40 (Week 20, Week 24, Week 28 ,Week 32, Week 44, Week 56 referring to core study)Population: The Extension study set comprised all subjects who were randomized and to whom study treatment had been assigned and had at least one visit in the extension study.
IGA score is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. The scale ranges from 0=clear to 4=severe. It is a static scale and doesn't refer to previous status of the subject. IGA response is an achievement of an IGA score of 0 or 1 with a 2-point reduction from baseline without use of confounding therapy up to the assessment time point. Treatment discontinuations for lack of efficacy or AE are considered non-responders.Presentation of the results is stratified by if patients were re-randomized from the core study or not. As all patients were rolling over from the core study, in addition to the timeframe referring to the start in this extension study, the timeframe corresponding to the start in the core study (+16 weeks) are provided in parenthesis. Percentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline IGA as covariates.
Outcome measures
| Measure |
ZPL389 30mg
n=34 Participants
Dose 1 of ZPL389 + TCS and/or TCI
|
ZPL389 50mg
n=30 Participants
Dose 2 of ZPL389 + TCS and/or TCI
|
ZPL389 30mg Continuing After Core Study
n=26 Participants
30mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study
|
ZPL389 50mg Continuing After Core Study
n=33 Participants
50mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study
|
|---|---|---|---|---|
|
Percentage of Investigator's Global Assessment (IGA) Responders Over Time
week 4 (week 20 referring to core study)
|
2.9 Percentage of participants
Interval -2.7 to 8.6
|
5.2 Percentage of participants
Interval -3.4 to 13.8
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
3.0 Percentage of participants
Interval -2.8 to 8.9
|
|
Percentage of Investigator's Global Assessment (IGA) Responders Over Time
Week 8 (week 24 referring to core study)
|
2.9 Percentage of participants
Interval -2.7 to 8.6
|
4.8 Percentage of participants
Interval -3.9 to 13.5
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
3.1 Percentage of participants
Interval -2.8 to 9.0
|
|
Percentage of Investigator's Global Assessment (IGA) Responders Over Time
Week 12 (week 28 referring to core study)
|
3.5 Percentage of participants
Interval -3.1 to 10.1
|
4.0 Percentage of participants
Interval -4.4 to 12.4
|
0.0 Percentage of participants
Interval -1.0 to 1.1
|
3.0 Percentage of participants
Interval -2.8 to 8.9
|
|
Percentage of Investigator's Global Assessment (IGA) Responders Over Time
Week 16 (week 32 referring to core study)
|
3.9 Percentage of participants
Interval -3.3 to 11.0
|
5.9 Percentage of participants
Interval -3.7 to 15.5
|
0.0 Percentage of participants
Interval -1.7 to 1.9
|
0.0 Percentage of participants
Interval -2.0 to 2.4
|
|
Percentage of Investigator's Global Assessment (IGA) Responders Over Time
Week 28 (week 44 referring to core study)
|
0.0 Percentage of participants
Interval -3.7 to 6.4
|
7.5 Percentage of participants
Interval -3.7 to 18.7
|
0.0 Percentage of participants
Interval -1.4 to 1.6
|
1.5 Percentage of participants
Interval -3.8 to 6.9
|
|
Percentage of Investigator's Global Assessment (IGA) Responders Over Time
Week 40 (week 56 referring to core study)
|
3.4 Percentage of participants
Interval -4.4 to 11.2
|
9.1 Percentage of participants
Interval -2.7 to 20.8
|
0.0 Percentage of participants
Interval -4.3 to 7.0
|
0.0 Percentage of participants
Interval -4.2 to 7.0
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 16, Week 28, Week 40 (Week 20, Week 24, Week 28 ,Week 32, Week 44, Week 56 referring to core study)Population: The Extension study set comprised all subjects who were randomized and to whom study treatment had been assigned and had at least one visit in the extension study.
Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema. EASI50 response is defined as achieving ≥ 50% improvement (reduction) in EASI score compared to baseline. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders. Presentation of the results is stratified by if patients were re-randomized from the core study or not. As all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis. Percentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline EASI as covariates.
Outcome measures
| Measure |
ZPL389 30mg
n=34 Participants
Dose 1 of ZPL389 + TCS and/or TCI
|
ZPL389 50mg
n=30 Participants
Dose 2 of ZPL389 + TCS and/or TCI
|
ZPL389 30mg Continuing After Core Study
n=26 Participants
30mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study
|
ZPL389 50mg Continuing After Core Study
n=33 Participants
50mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study
|
|---|---|---|---|---|
|
Percentage of EASI50 Responders Over Time
week 4 (week 20 referring to core study)
|
14.7 Percentage of participants
Interval 2.8 to 26.6
|
13.0 Percentage of participants
Interval 0.8 to 25.2
|
7.7 Percentage of participants
Interval -2.6 to 17.9
|
12.1 Percentage of participants
Interval 1.0 to 23.3
|
|
Percentage of EASI50 Responders Over Time
Week 8 (week 24 referring to core study)
|
17.6 Percentage of participants
Interval 4.8 to 30.5
|
15.6 Percentage of participants
Interval 2.2 to 29.0
|
11.5 Percentage of participants
Interval -0.7 to 23.8
|
12.1 Percentage of participants
Interval 1.0 to 23.3
|
|
Percentage of EASI50 Responders Over Time
Week 12 (week 28 referring to core study)
|
22.3 Percentage of participants
Interval 8.0 to 36.6
|
15.9 Percentage of participants
Interval 2.5 to 29.3
|
10.7 Percentage of participants
Interval -1.5 to 23.0
|
12.1 Percentage of participants
Interval 1.0 to 23.3
|
|
Percentage of EASI50 Responders Over Time
Week 16 (week 32 referring to core study)
|
19.6 Percentage of participants
Interval 5.7 to 33.4
|
18.2 Percentage of participants
Interval 3.8 to 32.6
|
10.1 Percentage of participants
Interval -2.0 to 22.2
|
11.9 Percentage of participants
Interval 0.5 to 23.3
|
|
Percentage of EASI50 Responders Over Time
Week 28 (week 44 referring to core study)
|
10.8 Percentage of participants
Interval -1.0 to 22.6
|
14.8 Percentage of participants
Interval 0.8 to 28.8
|
14.0 Percentage of participants
Interval 0.1 to 27.8
|
14.2 Percentage of participants
Interval 1.6 to 26.8
|
|
Percentage of EASI50 Responders Over Time
Week 40 (week 56 referring to core study)
|
14.8 Percentage of participants
Interval 1.4 to 28.2
|
20.3 Percentage of participants
Interval 4.6 to 36.1
|
12.3 Percentage of participants
Interval -0.9 to 25.5
|
13.8 Percentage of participants
Interval 0.9 to 26.6
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 16, Week 28, Week 40 (Week 20, Week 24, Week 28 ,Week 32, Week 44, Week 56 referring to core study)Population: The Extension study set comprised all subjects who were randomized and to whom study treatment had been assigned and had at least one visit in the extension study.
Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema. EASI75 response is defined as a reduction from baseline of ≥ 75% in EASI score. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders. Presentation of the results is stratified by if patients were re-randomized from the core study or not. As all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis. Percentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline EASI as covariates.
Outcome measures
| Measure |
ZPL389 30mg
n=34 Participants
Dose 1 of ZPL389 + TCS and/or TCI
|
ZPL389 50mg
n=30 Participants
Dose 2 of ZPL389 + TCS and/or TCI
|
ZPL389 30mg Continuing After Core Study
n=26 Participants
30mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study
|
ZPL389 50mg Continuing After Core Study
n=33 Participants
50mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study
|
|---|---|---|---|---|
|
Percentage of EASI75 Responders Over Time
week 4 (week 20 referring to core study)
|
5.9 Percentage of participants
Interval -2.0 to 13.8
|
8.8 Percentage of participants
Interval -1.8 to 19.4
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
12.1 Percentage of participants
Interval 1.0 to 23.3
|
|
Percentage of EASI75 Responders Over Time
Week 8 (week 24 referring to core study)
|
5.9 Percentage of participants
Interval -2.0 to 13.8
|
14.2 Percentage of participants
Interval 1.0 to 27.4
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
9.1 Percentage of participants
Interval -0.7 to 18.9
|
|
Percentage of EASI75 Responders Over Time
Week 12 (week 28 referring to core study)
|
12.0 Percentage of participants
Interval 1.0 to 23.1
|
11.4 Percentage of participants
Interval -0.6 to 23.4
|
4.6 Percentage of participants
Interval -4.0 to 13.2
|
12.1 Percentage of participants
Interval 1.0 to 23.3
|
|
Percentage of EASI75 Responders Over Time
Week 16 (week 32 referring to core study)
|
8.4 Percentage of participants
Interval -1.8 to 18.7
|
10.3 Percentage of participants
Interval -1.3 to 22.0
|
0.0 Percentage of participants
Interval -4.2 to 6.6
|
4.9 Percentage of participants
Interval -3.0 to 12.8
|
|
Percentage of EASI75 Responders Over Time
Week 28 (week 44 referring to core study)
|
8.2 Percentage of participants
Interval -2.0 to 18.5
|
8.9 Percentage of participants
Interval -2.9 to 20.8
|
0.0 Percentage of participants
Interval -4.0 to 5.9
|
2.6 Percentage of participants
Interval -4.6 to 9.9
|
|
Percentage of EASI75 Responders Over Time
Week 40 (week 56 referring to core study)
|
10.0 Percentage of participants
Interval -2.4 to 22.3
|
13.5 Percentage of participants
Interval -0.2 to 27.3
|
6.1 Percentage of participants
Interval -4.0 to 16.2
|
3.2 Percentage of participants
Interval -4.4 to 10.8
|
Adverse Events
ZPL389 30mg in the First 16 Weeks of This Extension Study
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
ZPL389 50mg in the First 16 Weeks of This Extension Study
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
ZPL389 30 mg After 16 Weeks of Treatment in This Extension Study
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
ZPL389 50 mg After 16 Weeks of Treatment in This Extension Study
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ZPL389 30mg in the First 16 Weeks of This Extension Study
n=60 participants at risk
AEs starting up to week 16 of this extension study (week 16 to week 32 referring to core study)
|
ZPL389 50mg in the First 16 Weeks of This Extension Study
n=63 participants at risk
AEs starting up to week 16 of this extension study (week 16 to week 32 referring to core study)
|
ZPL389 30 mg After 16 Weeks of Treatment in This Extension Study
n=60 participants at risk
AEs from week 16 to week 67 of this extension study (week 32 to week 83 referring to core study)
|
ZPL389 50 mg After 16 Weeks of Treatment in This Extension Study
n=63 participants at risk
AEs from week 16 to week 67 of this extension study (week 32 to week 83 referring to core study)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.6%
1/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Hepatobiliary disorders
Steatohepatitis
|
0.00%
0/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.6%
1/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.6%
1/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Infections and infestations
Bronchitis
|
0.00%
0/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.6%
1/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.6%
1/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.6%
1/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Reproductive system and breast disorders
Prostatitis
|
1.7%
1/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.7%
1/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.6%
1/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.6%
1/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
Other adverse events
| Measure |
ZPL389 30mg in the First 16 Weeks of This Extension Study
n=60 participants at risk
AEs starting up to week 16 of this extension study (week 16 to week 32 referring to core study)
|
ZPL389 50mg in the First 16 Weeks of This Extension Study
n=63 participants at risk
AEs starting up to week 16 of this extension study (week 16 to week 32 referring to core study)
|
ZPL389 30 mg After 16 Weeks of Treatment in This Extension Study
n=60 participants at risk
AEs from week 16 to week 67 of this extension study (week 32 to week 83 referring to core study)
|
ZPL389 50 mg After 16 Weeks of Treatment in This Extension Study
n=63 participants at risk
AEs from week 16 to week 67 of this extension study (week 32 to week 83 referring to core study)
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
10.0%
6/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
6.3%
4/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
13.3%
8/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
4.8%
3/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.7%
1/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
6.3%
4/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.7%
1/60 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
4.8%
3/63 • Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER