Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis (NCT NCT03517566)
NCT ID: NCT03517566
Last Updated: 2021-10-08
Results Overview
Investigator's Global Assessment (IGA) score is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. It reflects a subject's overall disease severity for the whole body. The scale includes 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. It is a static scale and does not refer to previous status of the subject. IGA response is defined as achievement of an IGA score of 0 or 1 with a 2-point reduction from baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders. 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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
293 participants
Primary outcome timeframe
Week 16
Results posted on
2021-10-08
Participant Flow
There were 293 subjects randomized at baseline to one of the five treatment arms. Two mis-randomized subjects in the placebo arm were excluded from the baseline analysis population.
Participant milestones
| Measure |
Placebo
Placebo
|
ZPL389 3mg
ZPL389 3 mg oral powder
|
ZPL389 10 mg
ZPL389 10 mg oral powder
|
ZPL389 30mg
ZPL389 30 mg oral powder
|
ZPL389 50mg
ZPL389 50 mg oral powder
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
74
|
37
|
36
|
73
|
73
|
|
Overall Study
COMPLETED
|
42
|
16
|
21
|
39
|
41
|
|
Overall Study
NOT COMPLETED
|
32
|
21
|
15
|
34
|
32
|
Reasons for withdrawal
| Measure |
Placebo
Placebo
|
ZPL389 3mg
ZPL389 3 mg oral powder
|
ZPL389 10 mg
ZPL389 10 mg oral powder
|
ZPL389 30mg
ZPL389 30 mg oral powder
|
ZPL389 50mg
ZPL389 50 mg oral powder
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
2
|
2
|
8
|
7
|
|
Overall Study
Lack of Efficacy
|
3
|
2
|
1
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
1
|
0
|
1
|
1
|
|
Overall Study
Study terminated by Sponsor
|
11
|
5
|
6
|
14
|
12
|
|
Overall Study
Subject Decision /Guardian Decision
|
9
|
8
|
5
|
8
|
8
|
Baseline Characteristics
A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Placebo
n=72 Participants
Placebo
|
ZPL389 3mg
n=37 Participants
ZPL389 3 mg oral powder
|
ZPL389 10 mg
n=36 Participants
ZPL389 10 mg oral powder
|
ZPL389 30mg
n=73 Participants
ZPL389 30 mg oral powder
|
ZPL389 50mg
n=73 Participants
ZPL389 50 mg oral powder
|
Total
n=291 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 12.79 • n=5 Participants
|
38.1 years
STANDARD_DEVIATION 11.86 • n=7 Participants
|
32.1 years
STANDARD_DEVIATION 9.93 • n=5 Participants
|
34.9 years
STANDARD_DEVIATION 11.69 • n=4 Participants
|
35.2 years
STANDARD_DEVIATION 11.91 • n=21 Participants
|
35.0 years
STANDARD_DEVIATION 11.87 • n=8 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
125 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
166 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
51 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
208 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
73 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS.
Investigator's Global Assessment (IGA) score is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. It reflects a subject's overall disease severity for the whole body. The scale includes 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. It is a static scale and does not refer to previous status of the subject. IGA response is defined as achievement of an IGA score of 0 or 1 with a 2-point reduction from baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders. 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 |
Placebo
n=72 Participants
Placebo
|
ZPL389 3mg
n=37 Participants
ZPL389 3 mg oral powder
|
ZPL389 10 mg
n=36 Participants
ZPL389 10 mg oral powder
|
ZPL389 30mg
n=73 Participants
ZPL389 30 mg oral powder
|
ZPL389 50mg
n=73 Participants
ZPL389 50 mg oral powder
|
|---|---|---|---|---|---|
|
Percentage of IGA Responders at Week 16
|
1.9 Percentage of participants
Interval -1.6 to 5.3
|
3.3 Percentage of participants
Interval -4.3 to 10.9
|
7.2 Percentage of participants
Interval -2.3 to 16.8
|
0.8 Percentage of participants
Interval -2.0 to 3.7
|
6.9 Percentage of participants
Interval 0.6 to 13.2
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS
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.
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo
|
ZPL389 3mg
n=37 Participants
ZPL389 3 mg oral powder
|
ZPL389 10 mg
n=36 Participants
ZPL389 10 mg oral powder
|
ZPL389 30mg
n=73 Participants
ZPL389 30 mg oral powder
|
ZPL389 50mg
n=73 Participants
ZPL389 50 mg oral powder
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in EASI Score at Week 16
|
-55.0 Percent change from baseline
Interval -66.9 to -43.1
|
-49.4 Percent change from baseline
Interval -67.4 to -31.4
|
-50.7 Percent change from baseline
Interval -67.3 to -34.1
|
-46.2 Percent change from baseline
Interval -58.8 to -33.6
|
-52.7 Percent change from baseline
Interval -65.0 to -40.4
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12Population: Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS
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.
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo
|
ZPL389 3mg
n=37 Participants
ZPL389 3 mg oral powder
|
ZPL389 10 mg
n=36 Participants
ZPL389 10 mg oral powder
|
ZPL389 30mg
n=73 Participants
ZPL389 30 mg oral powder
|
ZPL389 50mg
n=73 Participants
ZPL389 50 mg oral powder
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in EASI Score Over Time
week 12
|
-55.4 Percent change from baseline
Interval -66.0 to -44.8
|
-48.7 Percent change from baseline
Interval -64.2 to -33.2
|
-54.1 Percent change from baseline
Interval -69.2 to -39.1
|
-45.1 Percent change from baseline
Interval -56.4 to -33.8
|
-52.7 Percent change from baseline
Interval -63.7 to -41.7
|
|
Percent Change From Baseline in EASI Score Over Time
Week 2
|
-17.1 Percent change from baseline
Interval -26.6 to -7.5
|
-20.1 Percent change from baseline
Interval -34.2 to -6.1
|
-10.3 Percent change from baseline
Interval -23.8 to 3.1
|
-14.2 Percent change from baseline
Interval -24.0 to -4.3
|
-16.7 Percent change from baseline
Interval -26.4 to -7.1
|
|
Percent Change From Baseline in EASI Score Over Time
week 4
|
-19.7 Percent change from baseline
Interval -30.6 to -8.9
|
-36.1 Percent change from baseline
Interval -51.4 to -20.9
|
-25.6 Percent change from baseline
Interval -40.6 to -10.7
|
-17.7 Percent change from baseline
Interval -29.0 to -6.4
|
-30.0 Percent change from baseline
Interval -40.6 to -19.4
|
|
Percent Change From Baseline in EASI Score Over Time
week 6
|
-42.8 Percent change from baseline
Interval -53.0 to -32.6
|
-47.6 Percent change from baseline
Interval -62.3 to -32.9
|
-43.2 Percent change from baseline
Interval -57.3 to -29.0
|
-33.2 Percent change from baseline
Interval -44.0 to -22.3
|
-43.5 Percent change from baseline
Interval -54.0 to -33.0
|
|
Percent Change From Baseline in EASI Score Over Time
week 8
|
-49.3 Percent change from baseline
Interval -61.1 to -37.4
|
-50.1 Percent change from baseline
Interval -66.8 to -33.4
|
-47.4 Percent change from baseline
Interval -63.9 to -30.9
|
-38.1 Percent change from baseline
Interval -50.5 to -25.7
|
-45.5 Percent change from baseline
Interval -57.4 to -33.6
|
SECONDARY outcome
Timeframe: Week 2, Week 4, Week 6, Week 8, Week 12, Week 16Population: Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS
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 without use of confounding therapy (e.g. rescue medication) up to the assessment time point. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders. 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 |
Placebo
n=72 Participants
Placebo
|
ZPL389 3mg
n=37 Participants
ZPL389 3 mg oral powder
|
ZPL389 10 mg
n=36 Participants
ZPL389 10 mg oral powder
|
ZPL389 30mg
n=73 Participants
ZPL389 30 mg oral powder
|
ZPL389 50mg
n=73 Participants
ZPL389 50 mg oral powder
|
|---|---|---|---|---|---|
|
Percentage of EASI50 Responders Over Time
week 6
|
18.4 Percentage of participants
Interval 9.4 to 27.4
|
15.0 Percentage of participants
Interval 2.5 to 27.5
|
15.1 Percentage of participants
Interval 2.5 to 27.7
|
9.5 Percentage of participants
Interval 2.1 to 16.8
|
16.7 Percentage of participants
Interval 8.0 to 25.4
|
|
Percentage of EASI50 Responders Over Time
Week 2
|
7.0 Percentage of participants
Interval 1.1 to 12.9
|
15.0 Percentage of participants
Interval 3.1 to 27.0
|
12.6 Percentage of participants
Interval 1.1 to 24.1
|
5.8 Percentage of participants
Interval 0.3 to 11.2
|
10.1 Percentage of participants
Interval 3.1 to 17.2
|
|
Percentage of EASI50 Responders Over Time
week 4
|
13.9 Percentage of participants
Interval 5.9 to 21.9
|
19.0 Percentage of participants
Interval 5.4 to 32.5
|
20.1 Percentage of participants
Interval 6.1 to 34.1
|
9.5 Percentage of participants
Interval 2.4 to 16.7
|
20.7 Percentage of participants
Interval 11.4 to 30.1
|
|
Percentage of EASI50 Responders Over Time
week 8
|
18.9 Percentage of participants
Interval 9.7 to 28.0
|
18.0 Percentage of participants
Interval 4.5 to 31.5
|
16.4 Percentage of participants
Interval 3.3 to 29.5
|
9.4 Percentage of participants
Interval 2.2 to 16.6
|
12.8 Percentage of participants
Interval 4.8 to 20.7
|
|
Percentage of EASI50 Responders Over Time
week 12
|
20.3 Percentage of participants
Interval 10.9 to 29.7
|
11.4 Percentage of participants
Interval -0.4 to 23.1
|
20.3 Percentage of participants
Interval 5.8 to 34.9
|
12.6 Percentage of participants
Interval 4.3 to 20.9
|
12.0 Percentage of participants
Interval 4.2 to 19.7
|
|
Percentage of EASI50 Responders Over Time
week 16
|
16.8 Percentage of participants
Interval 7.9 to 25.8
|
14.4 Percentage of participants
Interval 1.4 to 27.3
|
22.7 Percentage of participants
Interval 7.5 to 37.9
|
12.1 Percentage of participants
Interval 3.9 to 20.3
|
12.7 Percentage of participants
Interval 4.6 to 20.7
|
SECONDARY outcome
Timeframe: Week 2, Week 4, Week 6, Week 8, Week 12, Week 16Population: Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS
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 achieving ≥ 75% improvement (reduction) in EASI score compared to baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders. 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 |
Placebo
n=72 Participants
Placebo
|
ZPL389 3mg
n=37 Participants
ZPL389 3 mg oral powder
|
ZPL389 10 mg
n=36 Participants
ZPL389 10 mg oral powder
|
ZPL389 30mg
n=73 Participants
ZPL389 30 mg oral powder
|
ZPL389 50mg
n=73 Participants
ZPL389 50 mg oral powder
|
|---|---|---|---|---|---|
|
Percentage of EASI75 Responders Over Time
week 2
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval -3.0 to 4.4
|
0.0 Percentage of participants
Interval -3.1 to 4.4
|
1.4 Percentage of participants
Interval -1.3 to 4.1
|
1.5 Percentage of participants
Interval -1.4 to 4.3
|
|
Percentage of EASI75 Responders Over Time
week 4
|
2.8 Percentage of participants
Interval -1.0 to 6.6
|
7.0 Percentage of participants
Interval -2.0 to 16.0
|
1.7 Percentage of participants
Interval -3.9 to 7.2
|
1.8 Percentage of participants
Interval -1.6 to 5.2
|
1.4 Percentage of participants
Interval -1.3 to 4.2
|
|
Percentage of EASI75 Responders Over Time
week 6
|
5.6 Percentage of participants
Interval 0.3 to 10.9
|
10.3 Percentage of participants
Interval -0.4 to 21.0
|
7.1 Percentage of participants
Interval -1.9 to 16.1
|
1.8 Percentage of participants
Interval -2.0 to 5.7
|
7.4 Percentage of participants
Interval 1.2 to 13.6
|
|
Percentage of EASI75 Responders Over Time
week 8
|
6.0 Percentage of participants
Interval 0.4 to 11.6
|
10.9 Percentage of participants
Interval -0.2 to 21.9
|
8.5 Percentage of participants
Interval -1.8 to 18.8
|
2.5 Percentage of participants
Interval -1.8 to 6.8
|
6.1 Percentage of participants
Interval 0.4 to 11.9
|
|
Percentage of EASI75 Responders Over Time
week 12
|
4.6 Percentage of participants
Interval -0.4 to 9.6
|
6.2 Percentage of participants
Interval -3.1 to 15.6
|
10.6 Percentage of participants
Interval -0.9 to 22.0
|
2.8 Percentage of participants
Interval -1.6 to 7.2
|
5.8 Percentage of participants
Interval 0.0 to 11.7
|
|
Percentage of EASI75 Responders Over Time
week 16
|
9.7 Percentage of participants
Interval 2.6 to 16.8
|
7.1 Percentage of participants
Interval -2.8 to 16.9
|
12.9 Percentage of participants
Interval 0.3 to 25.5
|
3.1 Percentage of participants
Interval -1.7 to 7.8
|
9.3 Percentage of participants
Interval 2.1 to 16.6
|
SECONDARY outcome
Timeframe: Week 2, Week 4, Week 6, Week 8, Week 12Population: Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS
Investigator's Global Assessment (IGA) score is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. It reflects a subject's overall disease severity for the whole body. The scale includes 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. It is a static scale and does not refer to previous status of the subject. IGA response is defined as achievement of an IGA score of 0 or 1 with a 2-point reduction from baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders. 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 |
Placebo
n=72 Participants
Placebo
|
ZPL389 3mg
n=37 Participants
ZPL389 3 mg oral powder
|
ZPL389 10 mg
n=36 Participants
ZPL389 10 mg oral powder
|
ZPL389 30mg
n=73 Participants
ZPL389 30 mg oral powder
|
ZPL389 50mg
n=73 Participants
ZPL389 50 mg oral powder
|
|---|---|---|---|---|---|
|
Percentage of IGA Responders Over Time
week 2
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
2.7 Percentage of participants
Interval -2.5 to 7.9
|
0.0 Percentage of participants
Interval -0.7 to 0.8
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of IGA Responders Over Time
week 4
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
2.8 Percentage of participants
Interval -2.6 to 8.3
|
0.0 Percentage of participants
Interval -1.4 to 1.6
|
0.0 Percentage of participants
Interval -0.6 to 0.7
|
0.0 Percentage of participants
Interval -0.4 to 0.4
|
|
Percentage of IGA Responders Over Time
week 6
|
1.4 Percentage of participants
Interval -1.3 to 4.1
|
6.1 Percentage of participants
Interval -2.1 to 14.4
|
5.9 Percentage of participants
Interval -2.0 to 13.8
|
0.0 Percentage of participants
Interval -1.9 to 2.9
|
0.0 Percentage of participants
Interval -1.2 to 1.6
|
|
Percentage of IGA Responders Over Time
week 8
|
1.6 Percentage of participants
Interval -1.4 to 4.5
|
3.8 Percentage of participants
Interval -3.1 to 10.7
|
6.5 Percentage of participants
Interval -2.1 to 15.0
|
0.0 Percentage of participants
Interval -1.7 to 2.7
|
2.0 Percentage of participants
Interval -1.6 to 5.6
|
|
Percentage of IGA Responders Over Time
week 12
|
1.5 Percentage of participants
Interval -1.4 to 4.4
|
4.0 Percentage of participants
Interval -3.3 to 11.3
|
5.6 Percentage of participants
Interval -3.1 to 14.2
|
1.9 Percentage of participants
Interval -1.6 to 5.5
|
1.0 Percentage of participants
Interval -2.1 to 4.1
|
SECONDARY outcome
Timeframe: Up to week 20Population: Safety Set included all subjects who received at least one dose of study medication. Subjects were analyzed according to treatment received. The safety analyses were based on safety sets (SAF).
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.
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo
|
ZPL389 3mg
n=37 Participants
ZPL389 3 mg oral powder
|
ZPL389 10 mg
n=36 Participants
ZPL389 10 mg oral powder
|
ZPL389 30mg
n=73 Participants
ZPL389 30 mg oral powder
|
ZPL389 50mg
n=73 Participants
ZPL389 50 mg oral powder
|
|---|---|---|---|---|---|
|
Number of Patients With Adverse Events
AE
|
44 Participants
|
22 Participants
|
18 Participants
|
48 Participants
|
43 Participants
|
|
Number of Patients With Adverse Events
SAE
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events
AEs leading to discontinuation
|
7 Participants
|
3 Participants
|
2 Participants
|
11 Participants
|
12 Participants
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
ZPL389 3 mg
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
ZPL389 10 mg
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
ZPL389 30 mg
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
ZPL389 50 mg
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
All Patients
Serious events: 10 serious events
Other events: 105 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=72 participants at risk
Placebo
|
ZPL389 3 mg
n=37 participants at risk
ZPL389 3 mg oral powder
|
ZPL389 10 mg
n=36 participants at risk
ZPL389 10 mg oral powder
|
ZPL389 30 mg
n=73 participants at risk
ZPL389 30 mg oral powder
|
ZPL389 50 mg
n=73 participants at risk
ZPL389 50 mg oral powder
|
All Patients
n=291 participants at risk
All Patients
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/72 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/37 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.4%
1/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.34%
1/291 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Infections and infestations
Herpes dermatitis
|
0.00%
0/72 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/37 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.34%
1/291 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Infections and infestations
Peritonitis
|
0.00%
0/72 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/37 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.4%
1/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.34%
1/291 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Infections and infestations
Pneumonia
|
0.00%
0/72 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/37 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.4%
1/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.34%
1/291 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Pregnancy, puerperium and perinatal conditions
Risk of future pregnancy miscarriage
|
0.00%
0/72 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/37 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.34%
1/291 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.8%
2/72 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
2.7%
1/37 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.4%
1/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.7%
5/291 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
Other adverse events
| Measure |
Placebo
n=72 participants at risk
Placebo
|
ZPL389 3 mg
n=37 participants at risk
ZPL389 3 mg oral powder
|
ZPL389 10 mg
n=36 participants at risk
ZPL389 10 mg oral powder
|
ZPL389 30 mg
n=73 participants at risk
ZPL389 30 mg oral powder
|
ZPL389 50 mg
n=73 participants at risk
ZPL389 50 mg oral powder
|
All Patients
n=291 participants at risk
All Patients
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
2/72 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
2.7%
1/37 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.4%
1/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
6.8%
5/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
3.1%
9/291 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
General disorders
Influenza like illness
|
1.4%
1/72 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/37 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
4.1%
3/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
4.1%
3/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
3.1%
9/291 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
8/72 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
5.4%
2/37 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
5.5%
4/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
5.5%
4/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
6.9%
20/291 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Infections and infestations
Rhinitis
|
0.00%
0/72 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/37 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.4%
1/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.4%
1/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.4%
4/291 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
2/72 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
2.7%
1/37 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
8.2%
6/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.4%
1/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
4.1%
12/291 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Nervous system disorders
Dizziness
|
0.00%
0/72 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/37 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.4%
1/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
4.1%
3/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
2.1%
6/291 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Nervous system disorders
Headache
|
6.9%
5/72 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
2.7%
1/37 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
2.7%
2/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
5.5%
4/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
4.5%
13/291 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/72 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
5.4%
2/37 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.4%
1/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.4%
1/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.7%
5/291 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.8%
2/72 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
5.4%
2/37 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
4.1%
3/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
1.4%
1/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
2.7%
8/291 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
15.3%
11/72 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
16.2%
6/37 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
19.2%
14/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
11.0%
8/73 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
|
14.1%
41/291 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
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