Atopic Dermatitis
Conditions
Keywords
atopic dermatitis, AD, eczema, itch, pruritus, H4R, ZPL389
Brief summary
This extension study (CZPL389A2203E1) was designed as a 2-year (100 weeks) extension to the core study (CZPL389A2203/ NCT03517566) which is disclosed separately. It aimed to assess the short-term and long-term safety of (blinded) 30 mg o.d and 50 mg o.d ZPL389 with concomitant or intermittent use of topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI).
Detailed description
Subjects who had received ZPL389 30 mg or 50 mg doses in the core study (CZPL389A2203), 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. All subjects received concomitant or intermittent TCS and/or TCI along with ZPL389. Short-term safety was assessed up to week 16 of this extension study (week 16 to week 32 referring to the start of core study treatment) and long-term safety was assessed after week 16 of this extension study (after week 32 referring to the start of core study treatment). The entire planned time frame (100 weeks) was not assessed as originally planned due to early termination of the core and extension studies.
Interventions
DRUGZPL389 30mg
30mg of ZPL389; once daily
DRUGZPL389 50mg
50mg of ZPL389; once daily
DRUGTCS and/or TCI
Topical corticosteroids (TCS) and /or topical calcineurin inhibitors (TCI) were used concomitantly or intermittently based on disease severity.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must give a written, signed and dated informed consent * Subjects with atopic dermatitis who have participated in and completed 16 weeks of treatment in CZPL389A2203 study. * Willing and able to comply with scheduled visits, treatment plan, laboratory tests, diary completion and other study procedures.
Exclusion criteria
* Inability to use TCS and/or TCI due to history of important side effects of topical medication (e.g., intolerance or hypersensitivity reactions). * Treatment discontinued subject from CZPL389A2203 study. * Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study | 16 weeks (week 16 to week 32 referring to core 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. |
| Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study | From week 16 to week 67 of this extension study (week 32 to week 83 referring to core 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Investigator's Global Assessment (IGA) Responders Over Time | 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) | 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. |
| Percentage of EASI50 Responders Over Time | 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) | 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. |
| Percentage of EASI75 Responders Over Time | 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) | 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. |
Countries
Belgium, Canada, Finland, Germany, Iceland, Japan, Netherlands, Poland, Russia, Slovakia, Taiwan, United Kingdom, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| ZPL389 30mg Dose 1 of ZPL389 + TCS and/or TCI | 60 |
| ZPL389 50mg Dose 2 of ZPL389 + TCS and/or TCI | 63 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | ZPL389 30mg | ZPL389 50mg | Total |
|---|---|---|---|
| Age, Continuous | 34.8 years STANDARD_DEVIATION 12.18 | 34.4 years STANDARD_DEVIATION 11.24 | 34.6 years STANDARD_DEVIATION 11.66 |
| Race/Ethnicity, Customized Asian | 23 Participants | 20 Participants | 43 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 36 Participants | 42 Participants | 78 Participants |
| Sex: Female, Male Female | 24 Participants | 20 Participants | 44 Participants |
| Sex: Female, Male Male | 36 Participants | 43 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 63 | 0 / 60 | 0 / 63 |
| other Total, other adverse events | 6 / 60 | 8 / 63 | 9 / 60 | 6 / 63 |
| serious Total, serious adverse events | 2 / 60 | 5 / 63 | 0 / 60 | 2 / 63 |
Outcome results
Primary
Number of Patients With Adverse Events After 16 Weeks of Treatment in This 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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ZPL389 30mg | Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study | AEs leading to discontinuation | 0 Participants |
| ZPL389 30mg | Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study | Adverse events | 18 Participants |
| ZPL389 30mg | Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study | SAEs | 0 Participants |
| ZPL389 50mg | Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study | SAEs | 2 Participants |
| ZPL389 50mg | Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study | Adverse events | 20 Participants |
| ZPL389 50mg | Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study | AEs leading to discontinuation | 1 Participants |
Primary
Number of Patients With Adverse Events in the First 16 Weeks of This 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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ZPL389 30mg | Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study | Adverse events | 29 Participants |
| ZPL389 30mg | Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study | SAEs | 2 Participants |
| ZPL389 30mg | Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study | AEs leading to discontinuation | 2 Participants |
| ZPL389 50mg | Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study | SAEs | 5 Participants |
| ZPL389 50mg | Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study | Adverse events | 33 Participants |
| ZPL389 50mg | Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study | AEs leading to discontinuation | 3 Participants |
Secondary
Percentage of EASI50 Responders Over Time
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZPL389 30mg | Percentage of EASI50 Responders Over Time | week 4 (week 20 referring to core study) | 14.7 Percentage of participants |
| ZPL389 30mg | Percentage of EASI50 Responders Over Time | Week 28 (week 44 referring to core study) | 10.8 Percentage of participants |
| ZPL389 30mg | Percentage of EASI50 Responders Over Time | Week 12 (week 28 referring to core study) | 22.3 Percentage of participants |
| ZPL389 30mg | Percentage of EASI50 Responders Over Time | Week 8 (week 24 referring to core study) | 17.6 Percentage of participants |
| ZPL389 30mg | Percentage of EASI50 Responders Over Time | Week 40 (week 56 referring to core study) | 14.8 Percentage of participants |
| ZPL389 30mg | Percentage of EASI50 Responders Over Time | Week 16 (week 32 referring to core study) | 19.6 Percentage of participants |
| ZPL389 50mg | Percentage of EASI50 Responders Over Time | Week 12 (week 28 referring to core study) | 15.9 Percentage of participants |
| ZPL389 50mg | Percentage of EASI50 Responders Over Time | Week 28 (week 44 referring to core study) | 14.8 Percentage of participants |
| ZPL389 50mg | Percentage of EASI50 Responders Over Time | Week 40 (week 56 referring to core study) | 20.3 Percentage of participants |
| ZPL389 50mg | Percentage of EASI50 Responders Over Time | week 4 (week 20 referring to core study) | 13.0 Percentage of participants |
| ZPL389 50mg | Percentage of EASI50 Responders Over Time | Week 16 (week 32 referring to core study) | 18.2 Percentage of participants |
| ZPL389 50mg | Percentage of EASI50 Responders Over Time | Week 8 (week 24 referring to core study) | 15.6 Percentage of participants |
| ZPL389 30mg Continuing After Core Study | Percentage of EASI50 Responders Over Time | Week 40 (week 56 referring to core study) | 12.3 Percentage of participants |
| ZPL389 30mg Continuing After Core Study | Percentage of EASI50 Responders Over Time | Week 28 (week 44 referring to core study) | 14.0 Percentage of participants |
| ZPL389 30mg Continuing After Core Study | Percentage of EASI50 Responders Over Time | Week 8 (week 24 referring to core study) | 11.5 Percentage of participants |
| ZPL389 30mg Continuing After Core Study | Percentage of EASI50 Responders Over Time | Week 12 (week 28 referring to core study) | 10.7 Percentage of participants |
| ZPL389 30mg Continuing After Core Study | Percentage of EASI50 Responders Over Time | Week 16 (week 32 referring to core study) | 10.1 Percentage of participants |
| ZPL389 30mg Continuing After Core Study | Percentage of EASI50 Responders Over Time | week 4 (week 20 referring to core study) | 7.7 Percentage of participants |
| ZPL389 50mg Continuing After Core Study | Percentage of EASI50 Responders Over Time | week 4 (week 20 referring to core study) | 12.1 Percentage of participants |
| ZPL389 50mg Continuing After Core Study | Percentage of EASI50 Responders Over Time | Week 12 (week 28 referring to core study) | 12.1 Percentage of participants |
| ZPL389 50mg Continuing After Core Study | Percentage of EASI50 Responders Over Time | Week 28 (week 44 referring to core study) | 14.2 Percentage of participants |
| ZPL389 50mg Continuing After Core Study | Percentage of EASI50 Responders Over Time | Week 40 (week 56 referring to core study) | 13.8 Percentage of participants |
| ZPL389 50mg Continuing After Core Study | Percentage of EASI50 Responders Over Time | Week 8 (week 24 referring to core study) | 12.1 Percentage of participants |
| ZPL389 50mg Continuing After Core Study | Percentage of EASI50 Responders Over Time | Week 16 (week 32 referring to core study) | 11.9 Percentage of participants |
Secondary
Percentage of EASI75 Responders Over Time
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZPL389 30mg | Percentage of EASI75 Responders Over Time | Week 16 (week 32 referring to core study) | 8.4 Percentage of participants |
| ZPL389 30mg | Percentage of EASI75 Responders Over Time | Week 8 (week 24 referring to core study) | 5.9 Percentage of participants |
| ZPL389 30mg | Percentage of EASI75 Responders Over Time | Week 40 (week 56 referring to core study) | 10.0 Percentage of participants |
| ZPL389 30mg | Percentage of EASI75 Responders Over Time | week 4 (week 20 referring to core study) | 5.9 Percentage of participants |
| ZPL389 30mg | Percentage of EASI75 Responders Over Time | Week 12 (week 28 referring to core study) | 12.0 Percentage of participants |
| ZPL389 30mg | Percentage of EASI75 Responders Over Time | Week 28 (week 44 referring to core study) | 8.2 Percentage of participants |
| ZPL389 50mg | Percentage of EASI75 Responders Over Time | week 4 (week 20 referring to core study) | 8.8 Percentage of participants |
| ZPL389 50mg | Percentage of EASI75 Responders Over Time | Week 12 (week 28 referring to core study) | 11.4 Percentage of participants |
| ZPL389 50mg | Percentage of EASI75 Responders Over Time | Week 16 (week 32 referring to core study) | 10.3 Percentage of participants |
| ZPL389 50mg | Percentage of EASI75 Responders Over Time | Week 28 (week 44 referring to core study) | 8.9 Percentage of participants |
| ZPL389 50mg | Percentage of EASI75 Responders Over Time | Week 8 (week 24 referring to core study) | 14.2 Percentage of participants |
| ZPL389 50mg | Percentage of EASI75 Responders Over Time | Week 40 (week 56 referring to core study) | 13.5 Percentage of participants |
| ZPL389 30mg Continuing After Core Study | Percentage of EASI75 Responders Over Time | Week 16 (week 32 referring to core study) | 0.0 Percentage of participants |
| ZPL389 30mg Continuing After Core Study | Percentage of EASI75 Responders Over Time | Week 8 (week 24 referring to core study) | 0.0 Percentage of participants |
| ZPL389 30mg Continuing After Core Study | Percentage of EASI75 Responders Over Time | Week 12 (week 28 referring to core study) | 4.6 Percentage of participants |
| ZPL389 30mg Continuing After Core Study | Percentage of EASI75 Responders Over Time | Week 40 (week 56 referring to core study) | 6.1 Percentage of participants |
| ZPL389 30mg Continuing After Core Study | Percentage of EASI75 Responders Over Time | week 4 (week 20 referring to core study) | 0.0 Percentage of participants |
| ZPL389 30mg Continuing After Core Study | Percentage of EASI75 Responders Over Time | Week 28 (week 44 referring to core study) | 0.0 Percentage of participants |
| ZPL389 50mg Continuing After Core Study | Percentage of EASI75 Responders Over Time | week 4 (week 20 referring to core study) | 12.1 Percentage of participants |
| ZPL389 50mg Continuing After Core Study | Percentage of EASI75 Responders Over Time | Week 12 (week 28 referring to core study) | 12.1 Percentage of participants |
| ZPL389 50mg Continuing After Core Study | Percentage of EASI75 Responders Over Time | Week 16 (week 32 referring to core study) | 4.9 Percentage of participants |
| ZPL389 50mg Continuing After Core Study | Percentage of EASI75 Responders Over Time | Week 8 (week 24 referring to core study) | 9.1 Percentage of participants |
| ZPL389 50mg Continuing After Core Study | Percentage of EASI75 Responders Over Time | Week 40 (week 56 referring to core study) | 3.2 Percentage of participants |
| ZPL389 50mg Continuing After Core Study | Percentage of EASI75 Responders Over Time | Week 28 (week 44 referring to core study) | 2.6 Percentage of participants |
Secondary
Percentage of Investigator's Global Assessment (IGA) Responders Over Time
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZPL389 30mg | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 12 (week 28 referring to core study) | 3.5 Percentage of participants |
| ZPL389 30mg | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 16 (week 32 referring to core study) | 3.9 Percentage of participants |
| ZPL389 30mg | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | week 4 (week 20 referring to core study) | 2.9 Percentage of participants |
| ZPL389 30mg | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 40 (week 56 referring to core study) | 3.4 Percentage of participants |
| ZPL389 30mg | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 28 (week 44 referring to core study) | 0.0 Percentage of participants |
| ZPL389 30mg | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 8 (week 24 referring to core study) | 2.9 Percentage of participants |
| ZPL389 50mg | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 8 (week 24 referring to core study) | 4.8 Percentage of participants |
| ZPL389 50mg | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 28 (week 44 referring to core study) | 7.5 Percentage of participants |
| ZPL389 50mg | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 40 (week 56 referring to core study) | 9.1 Percentage of participants |
| ZPL389 50mg | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 16 (week 32 referring to core study) | 5.9 Percentage of participants |
| ZPL389 50mg | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 12 (week 28 referring to core study) | 4.0 Percentage of participants |
| ZPL389 50mg | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | week 4 (week 20 referring to core study) | 5.2 Percentage of participants |
| ZPL389 30mg Continuing After Core Study | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 40 (week 56 referring to core study) | 0.0 Percentage of participants |
| ZPL389 30mg Continuing After Core Study | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | week 4 (week 20 referring to core study) | 0.0 Percentage of participants |
| ZPL389 30mg Continuing After Core Study | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 8 (week 24 referring to core study) | 0.0 Percentage of participants |
| ZPL389 30mg Continuing After Core Study | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 12 (week 28 referring to core study) | 0.0 Percentage of participants |
| ZPL389 30mg Continuing After Core Study | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 16 (week 32 referring to core study) | 0.0 Percentage of participants |
| ZPL389 30mg Continuing After Core Study | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 28 (week 44 referring to core study) | 0.0 Percentage of participants |
| ZPL389 50mg Continuing After Core Study | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | week 4 (week 20 referring to core study) | 3.0 Percentage of participants |
| ZPL389 50mg Continuing After Core Study | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 40 (week 56 referring to core study) | 0.0 Percentage of participants |
| ZPL389 50mg Continuing After Core Study | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 8 (week 24 referring to core study) | 3.1 Percentage of participants |
| ZPL389 50mg Continuing After Core Study | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 28 (week 44 referring to core study) | 1.5 Percentage of participants |
| ZPL389 50mg Continuing After Core Study | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 12 (week 28 referring to core study) | 3.0 Percentage of participants |
| ZPL389 50mg Continuing After Core Study | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 16 (week 32 referring to core study) | 0.0 Percentage of participants |