| Primary | Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12 | Mean fold-changes from baseline at Week 12 in the biomarkers for general inflammation (Matrix Metallopeptidase [MMP]12), hyperplasia (Keratin [KRT]16), Th2 immune response (C-C motif chemokine ligand [CCL]17, CCL18, CCL26), and Th22 immune response (S100 calcium binding protein A [S100A]8, S100A9, S100A12), in lesional (LS) and non-lesional (NL) skin tissues, respectively. Expression levels from RT-PCR are normalized to the housekeeping gene RPLP0 by negatively transforming the Ct values to -dCt. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants measured and analyzed for each parameter at Week 12 visit. | Posted | | Mean | Standard Deviation | Fold change | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
| | | Title | Denominators | Categories |
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| CCL17 (LS) | - ParticipantsOG00014
- ParticipantsOG00113
- ParticipantsOG00213
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| Secondary | Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12 | Mean fold-changes from baseline in immunohistochemistry analysis in lesional skin endpoints at Week 12 are presented. Fold-changes are computed by obtaining the antilog of log2 fold-changes, retaining the sign for log2 fold-change. | The analysis population included all participants randomly assigned to study interventionand who took at least 1 dose of study intervention. Number Analyzed refers to the numberof participants evaluable for each category. | Posted | | Mean | 95% Confidence Interval | Fold change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Secondary | Fold-Change From Baseline in Epidermal Hyperplasia Markers in Skin Biopsies and Skin Thickness at Week 12 | Mean fold-changes from baseline in hyperplasia markers in skin biopsies at Week 12 are presented. Fold-changes are computed by obtaining the antilog of log2 fold-changes, retaining the sign for log2 fold-change. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed refers to the number of participants evaluable for each category. | Posted | | Mean | 95% Confidence Interval | Fold change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Secondary | Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 | OLINK Proteomics Microassay was used to analyze biomarkers in serum to assess the effect of abrocitinib on the blood biomarkers. Mean fold-changes at Week 12 from baseline are listed. Baseline is defined as the last observation on or prior to day of first dose (Day 1). | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants measured and analyzed for each parameter at Week 12 visit. | Posted | | Mean | Standard Deviation | Fold change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Secondary | Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12 | Mean percent changes from baseline at Week 12 in T-cell lymphocyte subset populations (CD3+ T cells, CD4+ T cells, CD8+ T cells, NK cells, B cells) are presented. Baseline is defined as the last observation on or prior to day of first dose (Day 1). | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants measured and analyzed for each parameter at Week 12 visit. | Posted | | Mean | Standard Deviation | Percent change | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Secondary | Response Based on at Least 4 Points Improvement in the Severity of Peak Pruritus Numerical Rating Scale (NRS) From Baseline and Changes From Baseline in Immunohistochemistry (IHC) and Gene Expression Biomarkers in Lesional Skin | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. Spearman correlation coefficient was calculated to assess the relationship between PP-NRS CFB and fold CFB of IHC and gene expression biomarkers. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and had response based on at least 4-points improvement from baseline in the severity of PP-NRS. Number Analyzed refers to the number of participants evaluable for each category. | Posted | | Number | | Spearman correlation coefficient | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 |
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| Secondary | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline at Week 2, 4, 8 and 12 | The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants measured and analyzed for each parameter at the specified visit. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline, Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Secondary | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12 | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants measured and analyzed for each parameter at the specified visit. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline, Week 2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Secondary | Percentage of Participants With >=4 Points at Baseline and Achieving >=4 Points Improvement From Baseline in Numeric Rating Scale for Severity of Pruritus (PP-NRS) at Weeks 2, 4, 8 and 12 | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Higher scores indicated worse itch. Participants who withdrew from the study were counted as non-responder. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants measured and analyzed for each parameter at the specified visit. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline, Week 2, 4, 8, 12 | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Secondary | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12 | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants measured and analyzed for each parameter at the specified visit. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline to Week 2, 4, 8 and 12 | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Secondary | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12 | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants measured and analyzed for each parameter at specified visit. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline to Week 2, 4, 8 and 12 | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Secondary | Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12 | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants measured and analyzed for each parameter at specified visit. | Posted | | Mean | Standard Deviation | Percent change | | Baseline and Week 2, 4, 8 and 12 | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | | Count of Participants | | Participants | | Baseline to 16 weeks | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) | A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | | Count of Participants | | Participants | | Baseline to 16 weeks | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Secondary | Number of Participants Who Discontinued From the Study Due to TEAEs | An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | | Count of Participants | | Participants | | Baseline to 16 weeks | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Secondary | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants with at least one observation of the given laboratory test. | Posted | | Number | | Participants | | Baseline to 16 weeks | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Other Pre-specified | Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12 | Clinical laboratory tests including red blood cell (erythrocytes) were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants measured and analyzed for each parameter at specified visit. | Posted | | Mean | Standard Deviation | 10^6 cells/mm^3 | | Baseline and Week 2, 4, 8 and 12 | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Other Pre-specified | Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12 | Clinical laboratory tests including reticulocytes were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants measured and analyzed for each parameter at specified visit. | Posted | | Mean | Standard Deviation | 10^3 cells/mm^3 | | Baseline and Week 2, 4, 8 and 12 | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Other Pre-specified | Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12 | Clinical laboratory tests including platelet counts were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants measured and analyzed for each parameter at specified visit. | Posted | | Mean | Standard Deviation | 10^3 cells/mm^3 | | Baseline and Week 2, 4, 8 and 12 | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Other Pre-specified | Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12 | Clinical laboratory tests including hs-CRP were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants measured and analyzed for each parameter at specified visit. | Posted | | Mean | Standard Deviation | milligrams per deciliter | | Baseline and Week 2, 4, 8 and 12 | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Other Pre-specified | Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12 | Clinical laboratory tests including interleukin were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants measured and analyzed for each parameter at specified visit. | Posted | | Mean | Standard Deviation | picograms per milliliter | | Baseline and Week 2, 4, 8 and 12 | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Other Pre-specified | Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12 | Clinical laboratory tests including erythropoietin were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants measured and analyzed for each parameter at specified visit. | Posted | | Mean | Standard Deviation | milliunits per milliliter | | Baseline and Week 2, 4, 8 and 12 | | | | ID | Title | Description |
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| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Other Pre-specified | Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12 | Clinical laboratory tests including thrombopoietin were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants measured and analyzed for each parameter at specified visit. | Posted | | Mean | Standard Deviation | Picograms per milliliter (pg/mL) | | Baseline and Week 2, 4, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | Adult participants with moderate-to-severe AD received placebo QD for 12 weeks. |
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| Other Pre-specified | Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12 | The severity and frequency of itch (pruritus) during the night due to AD was assessed using the Night Time Itch Scale Score. Participants assessed their worst itching due to AD during their most recent night's sleep on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Higher scores indicated worse itch. The frequency of itch was assessed using a 5-point qualitative scale, with responses including "Never", "Rarely", "Sometimes", "Often" and "Almost Always". | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants measured and analyzed for each parameter at specified visit. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and Week 2, 4, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. | | OG002 | Placebo | |
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| Other Pre-specified | Plasma PF-04965842 Concentration | Pharmacokinetic (PK) samples were collected at Week 4 and 12 for measurement of plasma concentration of PF-04965842. | The PK analysis included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants with the corresponding PK parameter measured and analyzed at specified visit. | Posted | | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | | Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose | | | | ID | Title | Description |
|---|
| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. |
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| Other Pre-specified | Plasma PF-06471658 (M1) Concentration | PK samples were collected at Week 4 and 12 for measurement of plasma concentration of abrocitinib's metabolite PF-06471658 (M1). | The PK analysis included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants with the corresponding PK parameter measured and analyzed at specified visit. | Posted | | Mean | Standard Deviation | ng/mL | | Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose | | | | ID | Title | Description |
|---|
| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. |
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| Other Pre-specified | Plasma PF-07055087 (M2) Concentration | PK samples were collected at Week 4 and 12 for measurement of plasma concentration of abrocitinib's metabolite PF-07055087 (M2). | The PK analysis included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants with the corresponding PK parameter measured and analyzed at specified visit. | Posted | | Mean | Standard Deviation | ng/mL | | Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose | | | | ID | Title | Description |
|---|
| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. |
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| Other Pre-specified | Plasma PF-07054874 (M4) Concentration | PK samples were collected at Week 4 and 12 for measurement of plasma concentration of abrocitinib's metabolites PF-07054874 (M4). | The PK analysis included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants with the corresponding PK parameter measured and analyzed at specified visit. | Posted | | Mean | Standard Deviation | ng/mL | | Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose | | | | ID | Title | Description |
|---|
| OG000 | Abrocitinib 100 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks. | | OG001 | Abrocitinib 200 mg QD | Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks. |
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