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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000595-15 | EudraCT Number |
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Core terminated due to lack of efficacy
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZPL389 30mg | Experimental | 30mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ZPL389 3mg/ 10mg in the core study) and for patients continuing in the same arm from the core study |
|
| ZPL389 50mg | Experimental | 50mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ZPL389 3mg/ 10mg in the core study) and for patients continuing in the same arm from the core study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZPL389 30mg | Drug | 30mg of ZPL389; once daily |
| |
| ZPL389 50mg |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 16 weeks (week 16 to week 32 referring to core study) |
| 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. | From week 16 to week 67 of this extension study (week 32 to week 83 referring to core study) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Litchfield Park | Arizona | 85340 | United States | ||
| Novartis Investigative Site |
Not provided
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
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Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ZPL389 30mg | Dose 1 of ZPL389 + TCS and/or TCI |
| FG001 | ZPL389 50mg | Dose 2 of ZPL389 + TCS and/or TCI |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 27, 2018 | Apr 7, 2021 |
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| Drug |
50mg of ZPL389; once daily |
|
| TCS and/or TCI | Drug | Topical corticosteroids (TCS) and /or topical calcineurin inhibitors (TCI) were used concomitantly or intermittently based on disease severity. |
|
| 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) |
| 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. | 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) |
| 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. | 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) |
| Fairborn |
| Ohio |
| 45324 |
| United States |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Toronto | Ontario | M4V 1R2 | Canada |
| Novartis Investigative Site | Helsinki | 00250 | Finland |
| Novartis Investigative Site | Turku | 20520 | Finland |
| Novartis Investigative Site | Bielefeld | 33647 | Germany |
| Novartis Investigative Site | Gera | 07548 | Germany |
| Novartis Investigative Site | Hamburg | 20537 | Germany |
| Novartis Investigative Site | Hamburg | 22391 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Memmingen | 87700 | Germany |
| Novartis Investigative Site | München | 80337 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| Novartis Investigative Site | Osnabrück | 49074 | Germany |
| Novartis Investigative Site | Kopavogur | 201 | Iceland |
| Novartis Investigative Site | Nagoya | Aichi-ken | 467-8602 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 060-0063 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 220-6208 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 221-0825 | Japan |
| Novartis Investigative Site | Sakai | Osaka | 593-8324 | Japan |
| Novartis Investigative Site | Shinjuku Ku | Tokyo | 162 8655 | Japan |
| Novartis Investigative Site | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Novartis Investigative Site | Fukuoka | 819 0167 | Japan |
| Novartis Investigative Site | Fukuoka | 819-0373 | Japan |
| Novartis Investigative Site | Kyoto | 606 8507 | Japan |
| Novartis Investigative Site | Tokyo | 158 0097 | Japan |
| Novartis Investigative Site | Breda | CK | 4818 | Netherlands |
| Novartis Investigative Site | Bergen op Zoom | 4624 VT | Netherlands |
| Novartis Investigative Site | Warsaw | Mazowian | 02 495 | Poland |
| Novartis Investigative Site | Rzeszów | 35 055 | Poland |
| Novartis Investigative Site | Warsaw | 04141 | Poland |
| Novartis Investigative Site | Chelyabinsk | 454092 | Russia |
| Novartis Investigative Site | Kazan' | 420012 | Russia |
| Novartis Investigative Site | Moscow | 123182 | Russia |
| Novartis Investigative Site | Saint Petersburg | 191123 | Russia |
| Novartis Investigative Site | Saint Petersburg | 194354 | Russia |
| Novartis Investigative Site | Saint Petersburg | 196143 | Russia |
| Novartis Investigative Site | Smolensk | 214019 | Russia |
| Novartis Investigative Site | Bardejov | SVK | 085 01 | Slovakia |
| Novartis Investigative Site | Bratislava | 85101 | Slovakia |
| Novartis Investigative Site | Levice | 934 01 | Slovakia |
| Novartis Investigative Site | SvidnÃk | 08901 | Slovakia |
| Novartis Investigative Site | Taichung | Taiwan ROC | 40201 | Taiwan |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | London | SE1 9RT | United Kingdom |
| Novartis Investigative Site | Portsmouth | PO6 6AD | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ZPL389 30mg | Dose 1 of ZPL389 + TCS and/or TCI |
| BG001 | ZPL389 50mg | Dose 2 of ZPL389 + TCS and/or TCI |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 16 weeks (week 16 to week 32 referring to core study) |
|
|
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | From week 16 to week 67 of this extension study (week 32 to week 83 referring to core study) |
| ||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
| |||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
| |||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
|
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
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ZPL389 30mg in the First 16 Weeks of This Extension Study | AEs starting up to week 16 of this extension study (week 16 to week 32 referring to core study) | 0 | 60 | 2 | 60 | 6 | 60 |
| EG001 | ZPL389 50mg in the First 16 Weeks of This Extension Study | AEs starting up to week 16 of this extension study (week 16 to week 32 referring to core study) | 0 | 63 | 5 | 63 | 8 | 63 |
| EG002 | ZPL389 30 mg After 16 Weeks of Treatment in This Extension Study | AEs from week 16 to week 67 of this extension study (week 32 to week 83 referring to core study) | 0 | 60 | 0 | 60 | 9 | 60 |
| EG003 | ZPL389 50 mg After 16 Weeks of Treatment in This Extension Study | AEs from week 16 to week 67 of this extension study (week 32 to week 83 referring to core study) | 0 | 63 | 2 | 63 | 6 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Steatohepatitis | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2020 | Apr 7, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| AEs leading to discontinuation |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| OG001 |
| ZPL389 50mg Re-randomized After Core Study |
50mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ ZPL389 3mg/ 10mg in the core study) |
| OG002 | ZPL389 30mg Continuing After Core Study | 30mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study |
| OG003 | ZPL389 50mg Continuing After Core Study | 50mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study |
|
|
50mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ ZPL389 3mg/ 10mg in the core study) |
| OG002 | ZPL389 30mg Continuing After Core Study | 30mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study |
| OG003 | ZPL389 50mg Continuing After Core Study | 50mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study |
|
|
50mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ ZPL389 3mg/ 10mg in the core study) |
| OG002 | ZPL389 30mg Continuing After Core Study | 30mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study |
| OG003 | ZPL389 50mg Continuing After Core Study | 50mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study |
|
|