Not provided
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Lack of efficacy
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This was a randomized, double-blind, placebo-controlled, parallel-group study to assess safety and efficacy of ZPL389 in subjects with moderate to severe atopic dermatitis with a total study duration up to 24 weeks
A screening period of up to 4 weeks was followed by a 16-week double blinded treatment period.
After the end of treatment visit, subjects were offered the possibility of ongoing treatment in the extension study (CZPL389A2203E1/ NCT03948334), or of entering the 4 week treatment-free follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | Placebo |
|
| ZPL389 3mg | Experimental | ZPL389 3 mg oral powder |
|
| ZPL389 10 mg | Experimental | ZPL389 10 mg oral powder |
|
| ZPL389 30mg | Experimental | ZPL389 30 mg oral powder |
|
| ZPL389 50mg | Experimental | ZPL389 50 mg oral powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | once daily from baseline until week 16 |
| |
| ZPL389 3mg |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of IGA Responders at Week 16 | 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. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in EASI Score at Week 16 | 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. | Baseline, Week 16 |
| Percent Change From Baseline in EASI Score Over Time |
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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 |
Not provided
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo |
| FG001 | ZPL389 3mg | ZPL389 3 mg oral powder |
| FG002 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 2, 2019 | Apr 7, 2021 |
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| Drug |
ZPL389 3 mg oral powder; once daily from baseline to week 16 |
|
| ZPL389 10mg | Drug | ZPL389 10 mg oral powder; once daily from baseline to week 16 |
|
| ZPL389 30mg | Drug | ZPL389 30 mg oral powder; once daily from baseline to week 16 |
|
| ZPL389 50mg | Drug | ZPL389 50 mg oral powder; once daily from baseline to week 16 |
|
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. |
| Baseline, Week 2, Week 4, Week 6, Week 8, Week 12 |
| 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 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 | Week 2, Week 4, Week 6, Week 8, Week 12, Week 16 |
| 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 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 | Week 2, Week 4, Week 6, Week 8, Week 12, Week 16 |
| Percentage of IGA Responders Over Time | 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. | Week 2, Week 4, Week 6, Week 8, Week 12 |
| Number of Patients With Adverse Events | 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. | Up to week 20 |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Novartis Investigative Site | San Diego | California | 92103 | United States |
| Novartis Investigative Site | San Diego | California | 92123 | United States |
| Novartis Investigative Site | Tampa | Florida | 33609 | United States |
| Novartis Investigative Site | Tampa | Florida | 33612 | United States |
| Novartis Investigative Site | Louisville | Kentucky | 40217 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45231 | United States |
| Novartis Investigative Site | Fairborn | Ohio | 45324 | United States |
| Novartis Investigative Site | Greer | South Carolina | 29651 | United States |
| Novartis Investigative Site | Houston | Texas | 77004 | United States |
| Novartis Investigative Site | West Jordan | Utah | 84088 | United States |
| Novartis Investigative Site | Vienna | A 1090 | Austria |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Markham | Ontario | L3P 1A8 | Canada |
| Novartis Investigative Site | Newmarket | Ontario | L3Y 5G8 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M4V 1R2 | Canada |
| Novartis Investigative Site | Waterloo | Ontario | N2J 1C4 | Canada |
| Novartis Investigative Site | Sainte-Hyacinthe | Quebec | J2S 66 | Canada |
| Novartis Investigative Site | Karlovy Vary | Czech Republic | 36001 | Czechia |
| Novartis Investigative Site | Nový Jičín | Czech Republic | 74101 | Czechia |
| Novartis Investigative Site | Prague | Prague 1 | 11000 | Czechia |
| Novartis Investigative Site | Prague | 100 00 | Czechia |
| Novartis Investigative Site | Helsinki | 00250 | Finland |
| Novartis Investigative Site | Tampere | 33520 | Finland |
| Novartis Investigative Site | Turku | 20520 | Finland |
| Novartis Investigative Site | Bielefeld | 33647 | Germany |
| Novartis Investigative Site | Braunschweig | 38100 | Germany |
| Novartis Investigative Site | Frankfurt | 60590 | Germany |
| Novartis Investigative Site | Gera | 07548 | Germany |
| Novartis Investigative Site | Halle | 06108 | 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 | Debrecen | 4032 | Hungary |
| 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 | Kobe | Hyōgo | 654 0011 | 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 | Shinagawa Ku | Tokyo | 141 8625 | 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 | Bergen op Zoom | 4624 VT | Netherlands |
| Novartis Investigative Site | Breda | 4818 CK | Netherlands |
| Novartis Investigative Site | Groningen | 9713 GZ | Netherlands |
| Novartis Investigative Site | Rotterdam | 3015 CE | Netherlands |
| Novartis Investigative Site | Warsaw | Mazowian | 02 495 | Poland |
| Novartis Investigative Site | Katowice | 40-648 | 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 | Krasnodar | 350020 | Russia |
| Novartis Investigative Site | Moscow | 123182 | Russia |
| Novartis Investigative Site | Petrozavodsk | 185019 | Russia |
| Novartis Investigative Site | Saint Petersburg | 191123 | Russia |
| Novartis Investigative Site | Saint Petersburg | 192007 | Russia |
| Novartis Investigative Site | Saint Petersburg | 194223 | Russia |
| Novartis Investigative Site | Saint Petersburg | 194325 | Russia |
| Novartis Investigative Site | Saint Petersburg | 196143 | Russia |
| Novartis Investigative Site | Saint Petersburg | 196240 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197136 | Russia |
| Novartis Investigative Site | Smolensk | 214019 | Russia |
| Novartis Investigative Site | Stavropol | 355020 | Russia |
| Novartis Investigative Site | Yekaterinburg | 620023 | Russia |
| Novartis Investigative Site | Yekaterinburg | 620109 | 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 | Svidník | 08901 | Slovakia |
| Novartis Investigative Site | Taichung | Taiwan ROC | 40201 | Taiwan |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Plymouth | Devon | PL6 8DH | United Kingdom |
| Novartis Investigative Site | Dudley | West Midlands | DY1 2HQ | United Kingdom |
| Novartis Investigative Site | Liverpool | L14 3PE | United Kingdom |
| Novartis Investigative Site | London | SE1 9RT | United Kingdom |
| Novartis Investigative Site | Portsmouth | PO3 6AD | United Kingdom |
| ZPL389 10 mg |
ZPL389 10 mg oral powder |
| FG003 | ZPL389 30mg | ZPL389 30 mg oral powder |
| FG004 | ZPL389 50mg | ZPL389 50 mg oral powder |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All subjects to whom study treatment was assigned. Two Mis-randomized (mis-randomized in Interactive Response Technology (IRT)) subjects in the placebo group were excluded. Mis-randomized subjects were defined as cases where IRT was contacted by the site either prematurely or inappropriately prior to confirmation of the subject's final randomization eligibility and no study medication was administered to the subject.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo |
| BG001 | ZPL389 3mg | ZPL389 3 mg oral powder |
| BG002 | ZPL389 10 mg | ZPL389 10 mg oral powder |
| BG003 | ZPL389 30mg | ZPL389 30 mg oral powder |
| BG004 | ZPL389 50mg | ZPL389 50 mg oral powder |
| BG005 | 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 | Percentage of IGA Responders at Week 16 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 16 |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in EASI Score at Week 16 | 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. | 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 | Posted | Least Squares Mean | 95% Confidence Interval | Percent change from baseline | Baseline, Week 16 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in EASI Score 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. | 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 | Posted | Least Squares Mean | 95% Confidence Interval | Percent change from baseline | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| 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 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 | 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 | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 2, Week 4, Week 6, Week 8, Week 12, Week 16 |
| |||||||||||||||||||||||||||||||||||||||
| 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 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 | 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 | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 2, Week 4, Week 6, Week 8, Week 12, Week 16 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of IGA Responders Over Time | 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. | 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 | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 2, Week 4, Week 6, Week 8, Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Adverse Events | 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. | 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). | Posted | Count of Participants | Participants | Up to week 20 |
|
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
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 | Placebo | Placebo | 0 | 72 | 2 | 72 | 27 | 72 |
| EG001 | ZPL389 3 mg | ZPL389 3 mg oral powder | 0 | 37 | 1 | 37 | 14 | 37 |
| EG002 | ZPL389 10 mg | ZPL389 10 mg oral powder | 0 | 36 | 3 | 36 | 8 | 36 |
| EG003 | ZPL389 30 mg | ZPL389 30 mg oral powder | 0 | 73 | 1 | 73 | 30 | 73 |
| EG004 | ZPL389 50 mg | ZPL389 50 mg oral powder | 0 | 73 | 3 | 73 | 26 | 73 |
| EG005 | All Patients | All Patients | 0 | 291 | 10 | 291 | 105 | 291 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Herpes dermatitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Risk of future pregnancy miscarriage | Pregnancy, puerperium and perinatal conditions | 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 |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | 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 | Jun 29, 2021 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D011537 | Pruritus |
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| 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 |
|
| Multiple |
|
ZPL389 50 mg oral powder
|
|
ZPL389 50 mg oral powder
|
|
| OG003 |
| ZPL389 30mg |
ZPL389 30 mg oral powder |
| OG004 | ZPL389 50mg | ZPL389 50 mg oral powder |
|
|
| OG003 |
| ZPL389 30mg |
ZPL389 30 mg oral powder |
| OG004 | ZPL389 50mg | ZPL389 50 mg oral powder |
|
|
ZPL389 10 mg oral powder |
| OG003 | ZPL389 30mg | ZPL389 30 mg oral powder |
| OG004 | ZPL389 50mg | ZPL389 50 mg oral powder |
|
|
| OG004 | ZPL389 50mg | ZPL389 50 mg oral powder |
|
|