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A Randomised, Adaptive Design, Double-Blind (3rd Party Open), Placebo Controlled, Sequential Group Study to Determine the Safety,Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of a Topical ZPL-5212372 (1.0% w/w) Ointment Administered for up to 2 Weeks in Adult Healthy Volunteers and Patients with Moderate to Severe Atopic Dermatitis
This study was a randomised, adaptive design, double blind (3rd party open), placebo controlled, sequential group study in both healthy volunteers and patients with moderate to severe AD. This study was divided into 3 separate, sequential cohorts:
Subjects received 1.0% (w/w) ZPL-5212372 or matched placebo ointment topically, twice daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1a | Experimental | ZPL-5212372 1% w/w Ointment BID |
|
| Cohort 1b | Placebo Comparator | Placebo Ointment BID |
|
| Cohort 2a | Experimental | ZPL-5212372 1% w/w Ointment BID |
|
| Cohort 2b | Placebo Comparator | Placebo Ointment BID |
|
| Cohort 3a | Experimental | ZPL-5212372 1% w/w OIntment BID |
|
| Cohort 3b | Placebo Comparator | Placebo Ointment BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZPL-5212372 1% w/w Ointment BID | Drug |
| ||
| Placebo Ointment BID |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in EASI Score in Cohort 3 | The EASI is a validated tool used to measure the severity and extent of atopic eczema (Eczema Area and Severity Index). The body is divided into 4 sections of total skin area: head including neck (10%); arms including extremities (20%); trunk (30%) and legs including extremities (40%). Each area is scored and the 4 scores are combined into the final EASI. The severity parameters are measured on a scale of 0 to 3 (from none to severe). For each section, the percentage area of skin involved with eczema is estimated and transformed into an extent grade from 0 to 6, from 0% of involved skin area with eczema to 90-100% of involved skin area with eczema. The sum of all four severity parameters is calculated for each section of skin and then multiplied by the weight of the respective section. This value is then multiplied by the extent score for that body area. The EASI value can range from 0-72, a higher score indicates more severe disease. | Day 1 and Day 14 |
| Percent Change From Baseline in EASI Score Over Time in Cohort 3 - Observed Case | The EASI is a validated tool used to measure the severity and extent of atopic eczema (Eczema Area and Severity Index). The body is divided into 4 sections of total skin area: head including neck (10%); arms including extremities (20%); trunk (30%) and legs including extremities (40%). Each area is scored and the 4 scores are combined into the final EASI. The severity parameters are measured on a scale of 0 to 3 (from none to severe). For each section, the percentage area of skin involved with eczema is estimated and transformed into an extent grade from 0 to 6, from 0% of involved skin area with eczema to 90-100% of involved skin area with eczema. The sum of all four severity parameters is calculated for each section of skin and then multiplied by the weight of the respective section. This value is then multiplied by the extent score for that body area. The EASI value can range from 0-72, a higher score indicates more severe disease. | Days 1, 5, 8, 10, and 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of EASI-50 and EASI-75 Responders at Week 2 - Cohort 3 | The proportion of subjects who achieved EASI-50 and EASI-75 responses at Week 2 were compared between treatment groups. EASI-50 was defined as a ≥50% reduction from baseline in EASI score at Week 2. EASI-75 was defined as a ≥75% reduction from baseline in EASI score at Week 2. | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| ZPL-5212372 Cmax for Patients in Cohort 2 | PK parameters for patients who had ointment applied over 40% BSA. | Day 1, Day 7 |
| ZPL-5212372 AUCt for Patients in Cohort 2 | PK parameters for patients who had ointment applied over 40% BSA. |
Inclusion Criteria:
or
Males and females aged 18-65 years inclusive with physician documented history or diagnosis of atopic dermatitis for at least 6 months prior to screening. AD should be diagnosed by the Eichenfield revised criteria of Hanifin and Rajka.
For Atopic Dermatitis Patients:
Eczema Area and Severity Index (EASI) of ≥9 and <48 at Screening and an EASI of ≥12 and <48 at Day 1.
An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day 1.
Atopic dermatitis affecting between ≥10 to <40% BSA at Screening and ≥10% to <50% BSA on Day 1.
All Subjects:
Evidence of a personally signed and dated informed consent form, indicating that the subject has been informed of all pertinent aspects of the study.
Exclusion Criteria:
For Healthy Subjects
For Atopic Dermatitis Patients:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Parneix, MD | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MAC | Blackpool | United Kingdom | ||||
| MAC |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (ZPL-5212372) | ZPL-5212372 1% w/w Ointment BID |
| FG001 | Cohort 1 - Placebo | Placebo Ointment BID |
| 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 16, 2017 | Feb 23, 2018 |
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| Drug |
|
| Percentage of Responders on Investigators Global Assessment in Cohort 3 | The following secondary endpoints were assessed for IGA: A subject was considered as having IGA success if they achieved a score of 'Clear' or 'Almost clear'; note, as subjects required a score of ≥3 to enter the study they must have had a reduction of ≥2 from baseline to achieve success A subject was considered as having an IGA response if they achieved a score of 'Clear' or 'Almost clear', or a reduction of ≥2 from baseline IGA was summarized for the FAS with counts and percentages by treatment at each visit. | Day 14 |
| Change From Baseline in NRS for Pruritus at Week 2 - Observed Case in Cohort 3 | Numerical Rating Scale (NRS) for Pruritus (worst itch). The Pruritus NRS is an assessment tool that will be used to assess the subject's worst itch as a result of AD in the previous 24 hours. They will be asked the following question: On a scale of 0 (No Itching) to 10 (Itching as bad as you can imagine), please rate the WORST itching that you felt over the last 24 hours. | Day 1 to day 14 |
| Summary of Patient Global Impression of Change and Logistic Regression of Patient Global Impression of Change in Cohort 3 | Patient Global Impression of Change (PGIC) The PGIC scores were summarised for the FAS with counts and percentages in each treatment group. All data collected were included. The PGIC was dichotomized into responders, defined as responses of 'Very Much Improved', 'Much Improved' or 'Minimally improved' and non-responders (all other responses plus missing data). | End of treatment (day 15) |
| Change From Baseline in Body Surface Area at Week 2 - Observed Case in Cohort 3 | Body Surface Area (BSA). The percentage BSA affected was summarised at each visit, including change from baseline, by treatment group, using the Full Analysis Set. | Day 1 to day 14 |
| Day 1, Day 7 |
| ZPL-5212372 Trough Plasma Concentrations in Cohort 3 | PK parameters for patients who had ointment applied over 40% BSA. | Day 5, Day 8, Day 10, Day 15 |
| Leeds |
| United Kingdom |
| MAC | Manchester | United Kingdom |
| FG002 |
| Cohort 2 (ZPL-5212372) |
ZPL-5212372 1% w/w Ointment BID |
| FG003 | Cohort 2b - Placebo | Placebo Ointment BID |
| FG004 | Cohort 3 (ZPL-5212372) | ZPL-5212372 1% w/w OIntment BID |
| FG005 | Cohort 3 - Placebo | Placebo Ointment BID |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (ZPL-5212372) | ZPL-5212372 1% w/w Ointment BID |
| BG001 | Cohort 1 - Placebo | Placebo Ointment BID |
| BG002 | Cohort 2 (ZPL-5212372) | ZPL-5212372 1% w/w Ointment BID |
| BG003 | Cohort 2b - Placebo | Placebo Ointment BID |
| BG004 | Cohort 3 (ZPL-5212372) | ZPL-5212372 1% w/w OIntment BID |
| BG005 | Cohort 3 - Placebo | Placebo Ointment BID |
| BG006 | 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 and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | 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 | Percent Change From Baseline in EASI Score in Cohort 3 | The EASI is a validated tool used to measure the severity and extent of atopic eczema (Eczema Area and Severity Index). The body is divided into 4 sections of total skin area: head including neck (10%); arms including extremities (20%); trunk (30%) and legs including extremities (40%). Each area is scored and the 4 scores are combined into the final EASI. The severity parameters are measured on a scale of 0 to 3 (from none to severe). For each section, the percentage area of skin involved with eczema is estimated and transformed into an extent grade from 0 to 6, from 0% of involved skin area with eczema to 90-100% of involved skin area with eczema. The sum of all four severity parameters is calculated for each section of skin and then multiplied by the weight of the respective section. This value is then multiplied by the extent score for that body area. The EASI value can range from 0-72, a higher score indicates more severe disease. | Full Analysis set | Posted | Mean | Standard Error | percent change from baseline in EASI | Day 1 and Day 14 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percent Change From Baseline in EASI Score Over Time in Cohort 3 - Observed Case | The EASI is a validated tool used to measure the severity and extent of atopic eczema (Eczema Area and Severity Index). The body is divided into 4 sections of total skin area: head including neck (10%); arms including extremities (20%); trunk (30%) and legs including extremities (40%). Each area is scored and the 4 scores are combined into the final EASI. The severity parameters are measured on a scale of 0 to 3 (from none to severe). For each section, the percentage area of skin involved with eczema is estimated and transformed into an extent grade from 0 to 6, from 0% of involved skin area with eczema to 90-100% of involved skin area with eczema. The sum of all four severity parameters is calculated for each section of skin and then multiplied by the weight of the respective section. This value is then multiplied by the extent score for that body area. The EASI value can range from 0-72, a higher score indicates more severe disease. | Full Analysis set | Posted | Mean | Standard Error | percent change from baseline in EASI | Days 1, 5, 8, 10, and 15 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Summary of EASI-50 and EASI-75 Responders at Week 2 - Cohort 3 | The proportion of subjects who achieved EASI-50 and EASI-75 responses at Week 2 were compared between treatment groups. EASI-50 was defined as a ≥50% reduction from baseline in EASI score at Week 2. EASI-75 was defined as a ≥75% reduction from baseline in EASI score at Week 2. | Full analysis set | Posted | Number | participants | Day 14 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Responders on Investigators Global Assessment in Cohort 3 | The following secondary endpoints were assessed for IGA: A subject was considered as having IGA success if they achieved a score of 'Clear' or 'Almost clear'; note, as subjects required a score of ≥3 to enter the study they must have had a reduction of ≥2 from baseline to achieve success A subject was considered as having an IGA response if they achieved a score of 'Clear' or 'Almost clear', or a reduction of ≥2 from baseline IGA was summarized for the FAS with counts and percentages by treatment at each visit. | Full analysis set | Posted | Number | 95% Confidence Interval | Percentage of responders | Day 14 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in NRS for Pruritus at Week 2 - Observed Case in Cohort 3 | Numerical Rating Scale (NRS) for Pruritus (worst itch). The Pruritus NRS is an assessment tool that will be used to assess the subject's worst itch as a result of AD in the previous 24 hours. They will be asked the following question: On a scale of 0 (No Itching) to 10 (Itching as bad as you can imagine), please rate the WORST itching that you felt over the last 24 hours. | Full analysis set | Posted | Least Squares Mean | Standard Error | score on a scale | Day 1 to day 14 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Summary of Patient Global Impression of Change and Logistic Regression of Patient Global Impression of Change in Cohort 3 | Patient Global Impression of Change (PGIC) The PGIC scores were summarised for the FAS with counts and percentages in each treatment group. All data collected were included. The PGIC was dichotomized into responders, defined as responses of 'Very Much Improved', 'Much Improved' or 'Minimally improved' and non-responders (all other responses plus missing data). | Full analysis set | Posted | Count of Participants | Participants | End of treatment (day 15) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Body Surface Area at Week 2 - Observed Case in Cohort 3 | Body Surface Area (BSA). The percentage BSA affected was summarised at each visit, including change from baseline, by treatment group, using the Full Analysis Set. | Full analysis set | Posted | Least Squares Mean | Standard Error | score on a scale | Day 1 to day 14 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | ZPL-5212372 Cmax for Patients in Cohort 2 | PK parameters for patients who had ointment applied over 40% BSA. | Pharmacokinetic analysis set | Posted | Median | Full Range | pg/mL | Day 1, Day 7 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | ZPL-5212372 AUCt for Patients in Cohort 2 | PK parameters for patients who had ointment applied over 40% BSA. | Pharmacokinetic analysis set | Posted | Median | Full Range | h*pg/mL | Day 1, Day 7 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | ZPL-5212372 Trough Plasma Concentrations in Cohort 3 | PK parameters for patients who had ointment applied over 40% BSA. | Pharmacokinetic analysis set | Posted | Median | Full Range | pg/mL | Day 5, Day 8, Day 10, Day 15 |
|
|
Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days. All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 9 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 ZPL-5212372 10% BSA | Cohort 1 ZPL-5212372 10% BSA | 0 | 2 | 0 | 2 | 2 | 2 |
| EG001 | Cohort 1 ZPL-5212372 40% BSA | Cohort 1 ZPL-5212372 40% BSA | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | Cohort 1 Placebo 10% BSA | Cohort 1 Placebo 10% BSA | 0 | 1 | 0 | 1 | 1 | 1 |
| EG003 | Cohort 1 Placebo 40% BSA | Cohort 1 Placebo 40% BSA | 0 | 3 | 0 | 3 | 1 | 3 |
| EG004 | Cohort 2 ZPL-5212372 10% BSA | Cohort 2 ZPL-5212372 10% BSA | 0 | 2 | 0 | 2 | 2 | 2 |
| EG005 | Cohort 2 ZPL-5212372 40% BSA | Cohort 2 ZPL-5212372 40% BSA | 0 | 6 | 0 | 6 | 4 | 6 |
| EG006 | Cohort 2 Placebo 10% BSA | Cohort 2 Placebo 10% BSA | 0 | 1 | 0 | 1 | 1 | 1 |
| EG007 | Cohort 2 Placebo 40% BSA | Cohort 2 Placebo 40% BSA | 0 | 2 | 0 | 2 | 2 | 2 |
| EG008 | Cohort 3 ZPL-5212372 | Cohort 3 ZPL-5212372 | 0 | 20 | 0 | 20 | 17 | 20 |
| EG009 | Cohort 3 Placebo | Cohort 3 Placebo | 0 | 10 | 0 | 10 | 9 | 10 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| NEUTROPHILIA | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| APPLICATION SITE PARAESTHESIA | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| CATHETER SITE HAEMATOMA | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| FEELING ABNORMAL | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| PARONYCHIA | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ACNE | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DERMATITIS ALLERGIC | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DERMATITIS ATOPIC | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| REBOUND ATOPIC DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| SKIN BURNING SENSATION | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| TOOTH EXTRACTION | Surgical and medical procedures | MedDRA (18.1) | 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 |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 28, 2016 | Feb 23, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| 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 |
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|
|
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| Multiple imputations |
|
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| Last observation carried forward |
|
|
| Worst case imputation |
|
|
| Multiple imputations | ANCOVA | 0.4082 | The 1-sided p-value tests if the ZPL-5212372 LS mean is < the placebo LS mean. | Mean Difference (Net) | -3.01 | Standard Error of the Mean | 12.964 | 2-Sided | 90 | -24.39 | 18.36 | Superiority | ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable. |
| Last observation carried forward | ANCOVA | 0.0878 | The 1-sided p-value tests if the ZPL-5212372 LS mean is < the placebo LS mean. | Mean Difference (Net) | -18.27 | Standard Error of the Mean | 13.138 | 2-Sided | 90 | -40.65 | 4.11 | Superiority | ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable. |
| Worst case imputation | ANCOVA | 0.0275 | The 1-sided p-value tests if the ZPL-5212372 LS mean is < the placebo LS mean. | Mean Difference (Net) | -37.60 | Standard Error of the Mean | 18.748 | 2-Sided | 90 | -69.53 | -5.66 | Superiority | ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable. |
| Units | Counts |
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