Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE MECHANISM OF ACTION OF ABROCITINIB MONOTHERAPY IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03915496

Acronym

JADE MOA

Enrollment

Registered

2019-04-16

Start date

2020-06-18

Completion date

2021-11-16

Last updated

2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis, atopic eczema, eczema, JAK, janus kinase

Brief summary

B7451037 is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2a study to investigate the mechanism of action of PF-04965842 by correlating efficacy outcomes with changes from baseline in key skin and blood biomarkers in adult participants at least 18 years of age with moderate-to-severe atopic dermatitis. Participants will be screened within 28 days prior to the first dose of study intervention to confirm eligibility. A total of approximately 51 participants will be randomized in a 1:1:1 ratio to receive PF-04965842 200 mg once daily (QD), PF004965842 100 mg QD, or matching placebo QD for 12 weeks. At the end of the 12-week study treatment, qualified participants will have the option to enter the long-term extension study B7451015 (NCT03422822). Participants discontinuing early from this study will undergo a 4-week off-treatment follow-up period.

Interventions

DRUGPF-04965842 200 mg

PF-04965842 200 mg administered as two tablets to be taken orally once daily for 12 weeks

DRUGPF-04965842 100 mg

PF-04965842 100 mg administered as two tablets to be taken orally once daily for 12 weeks

DRUGPlacebo

Placebo administered as two tablets to be taken orally once daily for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of chronic moderate-to-severe atopic dermatitis (AD) for at least 1 year * Recent history of inadequate response to medicated topical therapy for AD or required systemic therapy to control disease * Moderate-to-severe AD defined as affected BSA at least 10%, IGA at least 3, EASI at least 16, Peak Pruritus NRS at least 4

Exclusion criteria

* A current or past medical history of conditions associated with thrombocytopenia, coagulopathy, or platelet dysfunction * Currently have active forms of other inflammatory skin diseases, i.e. not AD, or have evidence of skin conditions (e.g. psoriasis, seborrheic dermatitis, lupus) at the time of Day 1 that would interfere with evaluation of AD or response to treatment * Participants who have received prior treatment with any systemic JAK inhibitors * Require treatment with prohibited concomitant medication(s) or have received a prohibited concomitant medication within specified time frames prior to the first dose of study medication, including topical treatments that could affect AD * Pregnant or breastfeeding women or sexually-active women of childbearing potential who are unwilling to use contraception

Design outcomes

Primary

Measure	Time frame	Description
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	Baseline, 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.

Secondary

Measure	Time frame	Description
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Baseline, 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).
Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	Baseline, 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).
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	Baseline, Week 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). 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.
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	Baseline, Weeks 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.
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12	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.
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	Baseline, Week 2, 4, 8, 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.
Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12	Baseline to 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.
Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12	Baseline to 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.
Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12	Baseline and 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Baseline to 16 weeks	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.
Number of Participants With Serious Adverse Events (SAEs)	Baseline to 16 weeks	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.
Number of Participants Who Discontinued From the Study Due to TEAEs	Baseline to 16 weeks	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.
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Baseline to 16 weeks	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.
Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12	Baseline, 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.
Fold-Change From Baseline in Epidermal Hyperplasia Markers in Skin Biopsies and Skin Thickness at Week 12	Baseline, 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.

Other

Measure	Time frame	Description
Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12	Baseline and 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.
Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12	Baseline and 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.
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12	Baseline and 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.
Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12	Baseline and 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.
Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12	Baseline and 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.
Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12	Baseline and 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.
Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	Baseline and 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.
Plasma PF-04965842 Concentration	Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose	Pharmacokinetic (PK) samples were collected at Week 4 and 12 for measurement of plasma concentration of PF-04965842.
Plasma PF-07055087 (M2) Concentration	Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose	PK samples were collected at Week 4 and 12 for measurement of plasma concentration of abrocitinib's metabolite PF-07055087 (M2).
Plasma PF-07054874 (M4) Concentration	Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose	PK samples were collected at Week 4 and 12 for measurement of plasma concentration of abrocitinib's metabolites PF-07054874 (M4).
Plasma PF-06471658 (M1) Concentration	Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose	PK samples were collected at Week 4 and 12 for measurement of plasma concentration of abrocitinib's metabolite PF-06471658 (M1).
Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12	Baseline and 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.

Countries

Canada, United States

Participant flow

Recruitment details

A total of 46 adult participants with moderate-to-severe atopic dermatitis (AD) were randomized to the study and received study intervention, including 16 participants in the abrocitinib (PF-04965842) 100 mg once daily (QD) group, 14 participants in the abrocitinib 200 mg QD group, and 16 participants in the placebo group.

Participants by arm

Arm	Count
Abrocitinib 100 mg QD Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	16
Abrocitinib 200 mg QD Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	14
Placebo Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.	16
Total	46

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	2	1	2

Baseline characteristics

Characteristic	Abrocitinib 100 mg QD	Abrocitinib 200 mg QD	Placebo	Total
Age, Continuous	46.6 Years STANDARD_DEVIATION 19.41	41.4 Years STANDARD_DEVIATION 16.72	38.9 Years STANDARD_DEVIATION 15.64	42.4 Years STANDARD_DEVIATION 17.28
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	2 Participants	3 Participants	8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants	12 Participants	11 Participants	36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	2 Participants	2 Participants
Race/Ethnicity, Customized Asian	1 Participants	6 Participants	2 Participants	9 Participants
Race/Ethnicity, Customized Black or African American	4 Participants	1 Participants	2 Participants	7 Participants
Race/Ethnicity, Customized Multiracial	0 Participants	1 Participants	1 Participants	2 Participants
Race/Ethnicity, Customized Not reported	1 Participants	1 Participants	0 Participants	2 Participants
Race/Ethnicity, Customized White	10 Participants	5 Participants	11 Participants	26 Participants
Sex: Female, Male Female	11 Participants	7 Participants	3 Participants	21 Participants
Sex: Female, Male Male	5 Participants	7 Participants	13 Participants	25 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 16	0 / 14	0 / 16
other Total, other adverse events	10 / 16	7 / 14	7 / 16
serious Total, serious adverse events	0 / 16	0 / 14	1 / 16

Outcome results

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.

Time frame: Baseline, Week 12

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Abrocitinib 100 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	CCL18 (NL)	-18.307 Fold change	Standard Deviation 24.0808
Abrocitinib 100 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	S100A12 (NL)	4.052 Fold change	Standard Deviation 0.4124
Abrocitinib 100 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	S100A8 (LS)	-76.158 Fold change	Standard Deviation 181.1015
Abrocitinib 100 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	CCL17 (NL)	-0.506 Fold change	Standard Deviation 7.5268
Abrocitinib 100 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	S100A8 (NL)	-3.797 Fold change	Standard Deviation 3.9226
Abrocitinib 100 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	CCL26 (LS)	-3.886 Fold change	Standard Deviation 9.6426
Abrocitinib 100 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	S100A9 (LS)	-52.132 Fold change	Standard Deviation 113.0256
Abrocitinib 100 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	S100A9 (NL)	-2.781 Fold change	Standard Deviation 5.6012
Abrocitinib 100 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	CCL26 (NL)	-3.619 Fold change	Standard Deviation 2.1674
Abrocitinib 100 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	KRT16 (LS)	-24.604 Fold change	Standard Deviation 47.3896
Abrocitinib 100 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	CCL18 (LS)	-11.600 Fold change	Standard Deviation 18.9748
Abrocitinib 100 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	KRT16 (NL)	-3.179 Fold change	Standard Deviation 6.2518
Abrocitinib 100 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	MMP-12 (LS)	-44.200 Fold change	Standard Deviation 123.0708
Abrocitinib 100 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	MMP-12 (NL)	-20.822 Fold change	Standard Deviation 31.564
Abrocitinib 100 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	CCL17 (LS)	-5.896 Fold change	Standard Deviation 16.0867
Abrocitinib 100 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	S100A12 (LS)	-13.931 Fold change	Standard Deviation 23.974
Abrocitinib 200 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	CCL18 (LS)	-24.558 Fold change	Standard Deviation 46.2466
Abrocitinib 200 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	CCL26 (NL)	-4.369 Fold change	Standard Deviation 8.0621
Abrocitinib 200 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	S100A12 (NL)	-4.300 Fold change	Standard Deviation 4.2217
Abrocitinib 200 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	CCL18 (NL)	-12.328 Fold change	Standard Deviation 13.368
Abrocitinib 200 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	CCL17 (LS)	-15.604 Fold change	Standard Deviation 38.5469
Abrocitinib 200 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	S100A8 (LS)	-312.430 Fold change	Standard Deviation 395.0796
Abrocitinib 200 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	MMP-12 (NL)	-27.523 Fold change	Standard Deviation 16.5608
Abrocitinib 200 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	KRT16 (LS)	-53.285 Fold change	Standard Deviation 70.6935
Abrocitinib 200 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	S100A8 (NL)	-14.249 Fold change	Standard Deviation 13.254
Abrocitinib 200 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	MMP-12 (LS)	-306.161 Fold change	Standard Deviation 503.8312
Abrocitinib 200 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	S100A12 (LS)	-1322.88 Fold change	Standard Deviation 4594.187
Abrocitinib 200 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	S100A9 (LS)	-304.023 Fold change	Standard Deviation 376.0106
Abrocitinib 200 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	CCL26 (LS)	-0.464 Fold change	Standard Deviation 5.215
Abrocitinib 200 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	KRT16 (NL)	-2.947 Fold change	Standard Deviation 1.4188
Abrocitinib 200 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	S100A9 (NL)	-34.776 Fold change	Standard Deviation 42.4019
Abrocitinib 200 mg QD	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	CCL17 (NL)	-3.150 Fold change	Standard Deviation 2.6554
Placebo	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	S100A9 (NL)	-7.368 Fold change	Standard Deviation 10.0856
Placebo	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	CCL17 (LS)	-0.729 Fold change	Standard Deviation 4.0821
Placebo	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	CCL17 (NL)	-3.354 Fold change	Standard Deviation 7.68
Placebo	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	CCL18 (LS)	-1.096 Fold change	Standard Deviation 3.68
Placebo	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	CCL18 (NL)	-0.761 Fold change	Standard Deviation 2.8516
Placebo	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	CCL26 (LS)	-0.205 Fold change	Standard Deviation 1.7928
Placebo	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	CCL26 (NL)	0.026 Fold change	Standard Deviation 2.0613
Placebo	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	KRT16 (LS)	-1.898 Fold change	Standard Deviation 19.473
Placebo	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	KRT16 (NL)	-2.674 Fold change	Standard Deviation 7.2836
Placebo	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	MMP-12 (NL)	-1.897 Fold change	Standard Deviation 3.6968
Placebo	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	S100A12 (LS)	5.994 Fold change	Standard Deviation 57.0002
Placebo	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	S100A12 (NL)	-14.200 Fold change	Standard Deviation 21.2222
Placebo	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	S100A8 (LS)	1.213 Fold change	Standard Deviation 31.0236
Placebo	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	S100A8 (NL)	-8.394 Fold change	Standard Deviation 10.7181
Placebo	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	S100A9 (LS)	-2.136 Fold change	Standard Deviation 17.2326
Placebo	Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12	MMP-12 (LS)	-0.184 Fold change	Standard Deviation 3.0962

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).

Time frame: Baseline, Week 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Peptidase Inhibitor 3 (PI3)	-0.463 Fold change	Standard Deviation 0.6634
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Tumor necrosis factor receptor superfamily member 12A (TNFRSF12A)	-0.143 Fold change	Standard Deviation 0.3348
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	PDGF subunit A	-0.360 Fold change	Standard Deviation 0.3354
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CD40	-0.049 Fold change	Standard Deviation 0.1755
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Matrix metalloproteinase-1 (MMP-1)	-0.118 Fold change	Standard Deviation 0.1546
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	EN-RAGE	-0.175 Fold change	Standard Deviation 0.6414
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CD4	-0.252 Fold change	Standard Deviation 0.3139
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Interleukin 20 receptor subunit alpha (IL-20RA)	0.089 Fold change	Standard Deviation 0.2394
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	MCP-3	-0.418 Fold change	Standard Deviation 0.8078
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Cluster of differentiation (CD) 5	-0.373 Fold change	Standard Deviation 0.2546
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-18	-0.488 Fold change	Standard Deviation 0.4737
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Linker for activation of T cells (LAT)	-0.127 Fold change	Standard Deviation 0.4281
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-33	0.022 Fold change	Standard Deviation 0.2275
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-16	-0.512 Fold change	Standard Deviation 0.5606
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 23 (CCL23)	-0.247 Fold change	Standard Deviation 0.3367
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-10	-0.180 Fold change	Standard Deviation 0.4616
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-12	-0.548 Fold change	Standard Deviation 0.502
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Membrane cofactor protein (MCP)-4	-0.627 Fold change	Standard Deviation 0.727
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-6	-0.086 Fold change	Standard Deviation 0.956
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-12B	-0.560 Fold change	Standard Deviation 0.454
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 24 (CCL24)	-0.283 Fold change	Standard Deviation 0.5321
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-5	0.049 Fold change	Standard Deviation 0.2578
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-17C	-0.250 Fold change	Standard Deviation 1.2265
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-6RA	-0.162 Fold change	Standard Deviation 0.2087
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-8	0.080 Fold change	Standard Deviation 0.8463
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-7	-0.082 Fold change	Standard Deviation 0.4541
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CCL4	-0.187 Fold change	Standard Deviation 0.3558
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-2	0.005 Fold change	Standard Deviation 0.1927
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-27	-0.099 Fold change	Standard Deviation 0.1617
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Lipoprotein lipase (LPL)	-0.037 Fold change	Standard Deviation 0.5906
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-4RA	-0.075 Fold change	Standard Deviation 0.2436
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-13	-0.230 Fold change	Standard Deviation 0.481
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-4	-0.130 Fold change	Standard Deviation 0.6704
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-17D	0.057 Fold change	Standard Deviation 0.3222
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 17 (CCL17)	-0.619 Fold change	Standard Deviation 0.8281
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-20	-0.155 Fold change	Standard Deviation 0.2843
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CX3CL1	0.346 Fold change	Standard Deviation 0.4784
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Interferon (IFN)-gamma	0.264 Fold change	Standard Deviation 1.2382
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CCL3	-0.168 Fold change	Standard Deviation 0.4852
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Transforming growth factor (TGF)-beta-1	-0.199 Fold change	Standard Deviation 0.2853
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Interleukin 2 receptor subunit alpha (IL2-RA)	-0.852 Fold change	Standard Deviation 0.6237
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-1ra	-0.295 Fold change	Standard Deviation 0.4298
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CXCL16	0.031 Fold change	Standard Deviation 0.2575
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Interleukin (IL)-1 alpha	0.118 Fold change	Standard Deviation 0.4804
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Selectin E (SELE)	-0.520 Fold change	Standard Deviation 0.6198
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CXCL1	-0.218 Fold change	Standard Deviation 0.3795
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 25 (CCL25)	0.229 Fold change	Standard Deviation 0.3299
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CXCL9	-0.161 Fold change	Standard Deviation 0.6273
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 28 (CCL28)	0.014 Fold change	Standard Deviation 0.2452
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	P-selectin glycoprotein ligand-1 (PSGL-1)	-0.025 Fold change	Standard Deviation 0.2592
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CXCL11	-0.399 Fold change	Standard Deviation 0.6089
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 20 (CCL20)	-0.465 Fold change	Standard Deviation 1.1905
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	MCP-2	-0.204 Fold change	Standard Deviation 0.2714
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CXCL10	-0.268 Fold change	Standard Deviation 0.9825
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 19 (CCL19)	-0.653 Fold change	Standard Deviation 0.662
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Integrin subunit beta 2 (ITGB2)	-0.280 Fold change	Standard Deviation 0.3067
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Thymic stromal lymphopoietin (TSLP)	-0.100 Fold change	Standard Deviation 0.4871
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 16 (CCL16)	-0.258 Fold change	Standard Deviation 0.2716
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Tumor necrosis factor-related apoptosis-inducing ligand (TRAIL)	-0.062 Fold change	Standard Deviation 0.2606
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	X-C motif chemokine ligand 1 (XCL1)	-0.540 Fold change	Standard Deviation 0.4209
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 11 (CCL11)	0.030 Fold change	Standard Deviation 0.2617
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	MCP-1	0.053 Fold change	Standard Deviation 0.4337
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-X-C motif chemokine ligand 5 (CXCL5)	-0.208 Fold change	Standard Deviation 0.2889
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	MMP-12	-0.554 Fold change	Standard Deviation 0.9534
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Platelet-derived growth factor (PDGF) subunit B	-0.057 Fold change	Standard Deviation 0.2185
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Tumor necrosis factor (TNF)	-0.328 Fold change	Standard Deviation 0.356
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Tumor necrosis factor receptor superfamily member 9 (TNFRSF9)	-0.437 Fold change	Standard Deviation 0.3796
Abrocitinib 100 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	TNF-related weak inducer of apoptosis (TWEAK)	-0.057 Fold change	Standard Deviation 0.2239
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-17D	-0.222 Fold change	Standard Deviation 0.2921
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 25 (CCL25)	0.324 Fold change	Standard Deviation 0.4351
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-13	-0.490 Fold change	Standard Deviation 0.6399
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CD40	-0.065 Fold change	Standard Deviation 0.3002
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CXCL1	-0.375 Fold change	Standard Deviation 0.3356
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	MCP-1	0.108 Fold change	Standard Deviation 0.3722
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	TNF-related weak inducer of apoptosis (TWEAK)	-0.157 Fold change	Standard Deviation 0.1705
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 17 (CCL17)	-0.880 Fold change	Standard Deviation 1.063
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Selectin E (SELE)	-0.717 Fold change	Standard Deviation 0.6172
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Integrin subunit beta 2 (ITGB2)	-0.574 Fold change	Standard Deviation 0.2649
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Platelet-derived growth factor (PDGF) subunit B	-0.182 Fold change	Standard Deviation 0.3561
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	PDGF subunit A	-0.590 Fold change	Standard Deviation 0.3884
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Linker for activation of T cells (LAT)	-0.322 Fold change	Standard Deviation 0.3329
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 24 (CCL24)	-0.342 Fold change	Standard Deviation 0.2439
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Lipoprotein lipase (LPL)	0.281 Fold change	Standard Deviation 0.7465
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Interferon (IFN)-gamma	0.903 Fold change	Standard Deviation 1.958
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Interleukin 2 receptor subunit alpha (IL2-RA)	-0.921 Fold change	Standard Deviation 0.453
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Interleukin (IL)-1 alpha	-0.114 Fold change	Standard Deviation 0.2527
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 28 (CCL28)	0.108 Fold change	Standard Deviation 0.2932
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 20 (CCL20)	0.111 Fold change	Standard Deviation 0.8023
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 19 (CCL19)	-1.217 Fold change	Standard Deviation 0.9084
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 16 (CCL16)	-0.313 Fold change	Standard Deviation 0.1866
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 11 (CCL11)	0.109 Fold change	Standard Deviation 0.2891
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	MMP-12	-0.756 Fold change	Standard Deviation 0.6576
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Tumor necrosis factor receptor superfamily member 9 (TNFRSF9)	-0.608 Fold change	Standard Deviation 0.2665
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Tumor necrosis factor receptor superfamily member 12A (TNFRSF12A)	-0.048 Fold change	Standard Deviation 0.3744
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Matrix metalloproteinase-1 (MMP-1)	0.004 Fold change	Standard Deviation 0.2445
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Interleukin 20 receptor subunit alpha (IL-20RA)	-0.111 Fold change	Standard Deviation 0.2573
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-18	-0.578 Fold change	Standard Deviation 0.346
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-16	-0.697 Fold change	Standard Deviation 0.5642
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-12	-0.628 Fold change	Standard Deviation 0.3935
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-12B	-0.637 Fold change	Standard Deviation 0.3808
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-17C	0.136 Fold change	Standard Deviation 0.5533
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-7	-0.425 Fold change	Standard Deviation 0.5173
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-27	-0.177 Fold change	Standard Deviation 0.2611
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 23 (CCL23)	-0.519 Fold change	Standard Deviation 0.3958
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-20	-0.171 Fold change	Standard Deviation 0.2315
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-4	-0.308 Fold change	Standard Deviation 0.5324
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-4RA	-0.619 Fold change	Standard Deviation 0.7577
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-2	-0.069 Fold change	Standard Deviation 0.2345
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-8	0.090 Fold change	Standard Deviation 0.8062
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-5	-0.164 Fold change	Standard Deviation 0.3214
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-6	0.150 Fold change	Standard Deviation 1.4005
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-10	-0.087 Fold change	Standard Deviation 0.4255
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-33	-0.116 Fold change	Standard Deviation 0.2353
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Cluster of differentiation (CD) 5	-0.405 Fold change	Standard Deviation 0.1488
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CD4	-0.406 Fold change	Standard Deviation 0.2184
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Peptidase Inhibitor 3 (PI3)	-0.332 Fold change	Standard Deviation 0.6725
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Tumor necrosis factor (TNF)	-0.227 Fold change	Standard Deviation 0.6622
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-X-C motif chemokine ligand 5 (CXCL5)	-0.364 Fold change	Standard Deviation 0.4082
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	X-C motif chemokine ligand 1 (XCL1)	-0.897 Fold change	Standard Deviation 0.4253
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Thymic stromal lymphopoietin (TSLP)	-0.047 Fold change	Standard Deviation 0.561
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CXCL10	-0.549 Fold change	Standard Deviation 0.9508
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CXCL11	-0.695 Fold change	Standard Deviation 0.7402
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CXCL9	-0.406 Fold change	Standard Deviation 0.9061
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CXCL16	-0.033 Fold change	Standard Deviation 0.2503
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Transforming growth factor (TGF)-beta-1	-0.465 Fold change	Standard Deviation 0.2884
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CCL3	-0.171 Fold change	Standard Deviation 0.5503
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CX3CL1	0.458 Fold change	Standard Deviation 0.4269
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CCL4	-0.085 Fold change	Standard Deviation 0.5211
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Membrane cofactor protein (MCP)-4	-0.860 Fold change	Standard Deviation 0.6659
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	MCP-3	-0.676 Fold change	Standard Deviation 0.5462
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	MCP-2	-0.552 Fold change	Standard Deviation 0.3286
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-1ra	-0.234 Fold change	Standard Deviation 0.6936
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-6RA	-0.274 Fold change	Standard Deviation 0.1833
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Tumor necrosis factor-related apoptosis-inducing ligand (TRAIL)	-0.283 Fold change	Standard Deviation 0.2998
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	EN-RAGE	-0.383 Fold change	Standard Deviation 0.9149
Abrocitinib 200 mg QD	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	P-selectin glycoprotein ligand-1 (PSGL-1)	-0.087 Fold change	Standard Deviation 0.1646
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Tumor necrosis factor receptor superfamily member 12A (TNFRSF12A)	-0.078 Fold change	Standard Deviation 0.4294
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CD40	0.039 Fold change	Standard Deviation 0.2065
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Tumor necrosis factor receptor superfamily member 9 (TNFRSF9)	-0.136 Fold change	Standard Deviation 0.2562
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	MCP-3	-0.229 Fold change	Standard Deviation 0.7573
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Peptidase Inhibitor 3 (PI3)	-0.583 Fold change	Standard Deviation 0.8686
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	MMP-12	-0.631 Fold change	Standard Deviation 0.9298
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Integrin subunit beta 2 (ITGB2)	0.058 Fold change	Standard Deviation 0.1877
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Tumor necrosis factor (TNF)	0.036 Fold change	Standard Deviation 0.9515
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 11 (CCL11)	0.060 Fold change	Standard Deviation 0.2005
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	MCP-1	-0.081 Fold change	Standard Deviation 0.3836
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-X-C motif chemokine ligand 5 (CXCL5)	0.068 Fold change	Standard Deviation 0.4028
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 16 (CCL16)	-0.103 Fold change	Standard Deviation 0.204
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Selectin E (SELE)	-0.170 Fold change	Standard Deviation 0.3571
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	X-C motif chemokine ligand 1 (XCL1)	-0.051 Fold change	Standard Deviation 0.3028
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 19 (CCL19)	-0.012 Fold change	Standard Deviation 0.5347
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-2	0.050 Fold change	Standard Deviation 0.3024
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Thymic stromal lymphopoietin (TSLP)	0.019 Fold change	Standard Deviation 0.4495
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 20 (CCL20)	-0.333 Fold change	Standard Deviation 0.6612
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	MCP-2	-0.007 Fold change	Standard Deviation 0.2398
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CXCL10	0.363 Fold change	Standard Deviation 0.4782
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 28 (CCL28)	0.011 Fold change	Standard Deviation 0.2962
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 17 (CCL17)	0.108 Fold change	Standard Deviation 0.8299
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CXCL11	0.210 Fold change	Standard Deviation 0.4335
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 25 (CCL25)	0.149 Fold change	Standard Deviation 0.2235
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	P-selectin glycoprotein ligand-1 (PSGL-1)	-0.012 Fold change	Standard Deviation 0.1856
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CXCL9	0.159 Fold change	Standard Deviation 0.5395
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Interleukin (IL)-1 alpha	0.046 Fold change	Standard Deviation 0.3275
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CXCL1	-0.062 Fold change	Standard Deviation 0.3892
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Interleukin 2 receptor subunit alpha (IL2-RA)	-0.219 Fold change	Standard Deviation 0.3161
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-1ra	-0.128 Fold change	Standard Deviation 0.6599
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CXCL16	-0.011 Fold change	Standard Deviation 0.1563
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Interferon (IFN)-gamma	0.763 Fold change	Standard Deviation 1.1019
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 23 (CCL23)	-0.245 Fold change	Standard Deviation 0.4302
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Transforming growth factor (TGF)-beta-1	-0.077 Fold change	Standard Deviation 0.2521
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	EN-RAGE	0.175 Fold change	Standard Deviation 0.7755
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CX3CL1	0.012 Fold change	Standard Deviation 0.2771
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-17D	-0.105 Fold change	Standard Deviation 0.242
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CCL3	0.247 Fold change	Standard Deviation 0.7508
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-20	-0.137 Fold change	Standard Deviation 0.3877
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-13	-0.213 Fold change	Standard Deviation 0.6765
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Lipoprotein lipase (LPL)	-0.224 Fold change	Standard Deviation 0.734
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-4	-0.128 Fold change	Standard Deviation 0.3287
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-27	-0.073 Fold change	Standard Deviation 0.225
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-6RA	-0.022 Fold change	Standard Deviation 0.1817
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-4RA	-0.340 Fold change	Standard Deviation 0.5764
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-7	-0.020 Fold change	Standard Deviation 0.5239
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	C-C motif chemokine ligand 24 (CCL24)	-0.191 Fold change	Standard Deviation 0.2425
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-17C	-0.784 Fold change	Standard Deviation 1.0808
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Tumor necrosis factor-related apoptosis-inducing ligand (TRAIL)	0.086 Fold change	Standard Deviation 0.2172
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-8	0.152 Fold change	Standard Deviation 0.918
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-12B	-0.059 Fold change	Standard Deviation 0.323
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CCL4	0.204 Fold change	Standard Deviation 0.4349
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-5	-0.020 Fold change	Standard Deviation 0.3306
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-12	-0.141 Fold change	Standard Deviation 0.3341
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Linker for activation of T cells (LAT)	-0.169 Fold change	Standard Deviation 0.3493
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-6	-0.228 Fold change	Standard Deviation 1.1986
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-16	-0.222 Fold change	Standard Deviation 0.5656
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Platelet-derived growth factor (PDGF) subunit B	0.085 Fold change	Standard Deviation 0.2916
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-10	-0.182 Fold change	Standard Deviation 0.6735
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-18	-0.182 Fold change	Standard Deviation 0.4037
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Membrane cofactor protein (MCP)-4	-0.116 Fold change	Standard Deviation 0.6018
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	IL-33	-0.138 Fold change	Standard Deviation 0.2815
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Interleukin 20 receptor subunit alpha (IL-20RA)	-0.040 Fold change	Standard Deviation 0.2018
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	PDGF subunit A	-0.039 Fold change	Standard Deviation 0.1802
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Cluster of differentiation (CD) 5	-0.064 Fold change	Standard Deviation 0.164
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	Matrix metalloproteinase-1 (MMP-1)	-0.002 Fold change	Standard Deviation 0.1309
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	TNF-related weak inducer of apoptosis (TWEAK)	0.099 Fold change	Standard Deviation 0.1471
Placebo	Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12	CD4	-0.159 Fold change	Standard Deviation 0.322

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.

Time frame: Baseline, Week 12

Population: 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.

Arm	Measure	Group	Value (MEAN)
Abrocitinib 100 mg QD	Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12	CD11C	-1.622 Fold change
Abrocitinib 100 mg QD	Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12	CD3	-1.952 Fold change
Abrocitinib 100 mg QD	Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12	Fc Epsilon R1	-1.610 Fold change
Abrocitinib 100 mg QD	Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12	Macrophage mannose receptor 1	-1.249 Fold change
Abrocitinib 200 mg QD	Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12	Macrophage mannose receptor 1	-1.835 Fold change
Abrocitinib 200 mg QD	Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12	CD11C	-2.460 Fold change
Abrocitinib 200 mg QD	Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12	Fc Epsilon R1	-2.088 Fold change
Abrocitinib 200 mg QD	Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12	CD3	-2.371 Fold change
Placebo	Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12	Macrophage mannose receptor 1	-1.155 Fold change
Placebo	Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12	CD3	-1.054 Fold change
Placebo	Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12	Fc Epsilon R1	1.092 Fold change
Placebo	Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12	CD11C	-1.326 Fold change

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.

Time frame: Baseline, Week 12

Population: 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.

Arm	Measure	Group	Value (MEAN)
Abrocitinib 100 mg QD	Fold-Change From Baseline in Epidermal Hyperplasia Markers in Skin Biopsies and Skin Thickness at Week 12	Ki-67	-1.638 Fold change
Abrocitinib 100 mg QD	Fold-Change From Baseline in Epidermal Hyperplasia Markers in Skin Biopsies and Skin Thickness at Week 12	Thickness	-1.310 Fold change
Abrocitinib 200 mg QD	Fold-Change From Baseline in Epidermal Hyperplasia Markers in Skin Biopsies and Skin Thickness at Week 12	Ki-67	-1.911 Fold change
Abrocitinib 200 mg QD	Fold-Change From Baseline in Epidermal Hyperplasia Markers in Skin Biopsies and Skin Thickness at Week 12	Thickness	-1.508 Fold change
Placebo	Fold-Change From Baseline in Epidermal Hyperplasia Markers in Skin Biopsies and Skin Thickness at Week 12	Ki-67	-1.153 Fold change
Placebo	Fold-Change From Baseline in Epidermal Hyperplasia Markers in Skin Biopsies and Skin Thickness at Week 12	Thickness	-1.185 Fold change

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.

Time frame: Baseline to 16 weeks

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Abrocitinib 100 mg QD	Number of Participants Who Discontinued From the Study Due to TEAEs	All-causality TEAEs	2 Participants
Abrocitinib 100 mg QD	Number of Participants Who Discontinued From the Study Due to TEAEs	Treatment-related TEAEs	2 Participants
Abrocitinib 200 mg QD	Number of Participants Who Discontinued From the Study Due to TEAEs	All-causality TEAEs	1 Participants
Abrocitinib 200 mg QD	Number of Participants Who Discontinued From the Study Due to TEAEs	Treatment-related TEAEs	1 Participants
Placebo	Number of Participants Who Discontinued From the Study Due to TEAEs	All-causality TEAEs	2 Participants
Placebo	Number of Participants Who Discontinued From the Study Due to TEAEs	Treatment-related TEAEs	1 Participants

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.

Time frame: Baseline to 16 weeks

Population: 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.

Arm	Measure	Group	Value (NUMBER)
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Creatine Kinase (U/L) > 2.0*ULN	1 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Ketones ≥ 1	0 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Cholesterol (mg/dL) > 1.3*ULN	0 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Basophils/Leukocytes (%) > 1.2*ULN	1 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	URINE Protein ≥ 1	0 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	URINE Hemoglobin ≥ 1	2 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Leukocyte Esterase ≥ 1	5 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Hemoglobin (g/dL) <0.8*LLN	1 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	URINE Leukocytes (Scalar) ≥ 20	2 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Hyaline Casts (/LPF) > 1	2 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Eosinophils (10^3/mm3) > 1.2*ULN	5 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Hematocrit (%) < 0.8*LLN	1 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Erythrocytes (10^6/mm3) < 0.8*LLN	1 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Reticulocytes/Erythrocytes (%) > 1.5*ULN	1 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Reticulocytes (10^3/mm3) < 0.5*LLN	1 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Eosinophils/Leukocytes (%) > 1.2*ULN	6 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Platelets (10^3/mm3) < 0.5*LLN	1 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Leukocytes (10^3/mm3) < 0.6*LLN	1 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Lymphocytes (10^3/mm3) < 0.8*LLN	2 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Monocytes (10^3/mm3) > 1.2x ULN	0 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Monocytes/Leukocytes (%) > 1.2*ULN	1 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Indirect Bilirubin (mg/dL) > 1.5*ULN	0 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Prothrombin Time (sec) > 1.1*ULN	1 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Lymphocytes/Leukocytes (%) < 0.8*LLN	3 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Bilirubin (mg/dL) > 1.5*ULN	0 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Aspartate Aminotransferase (U/L) > 3.0*ULN	0 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Alanine Aminotransferase (U/L) > 3.0*ULN	0 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Lymphocytes/Leukocytes (%) > 1.2*ULN	0 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Gamma Glutamyl Transferase (U/L) > 3.0*ULN	1 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Lactate Dehydrogenase (U/L) > 3.0*ULN	0 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Creatinine (mg/dL) > 1.3*ULN	1 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Neutrophils (10^3/mm3) < 0.8*LLN	1 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Urate (mg/dL) > 1.2*ULN	1 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Potassium (mEq/L) < 0.9*LLN	1 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Bicarbonate (mEq/L) > 1.1*ULN	0 Participants
Abrocitinib 100 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Neutrophils/Leukocytes (%) < 0.8*LLN	0 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Monocytes (10^3/mm3) > 1.2x ULN	1 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Creatine Kinase (U/L) > 2.0*ULN	3 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Lymphocytes (10^3/mm3) < 0.8*LLN	0 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Bicarbonate (mEq/L) > 1.1*ULN	1 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Ketones ≥ 1	2 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Monocytes/Leukocytes (%) > 1.2*ULN	3 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Lactate Dehydrogenase (U/L) > 3.0*ULN	1 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	URINE Protein ≥ 1	1 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Basophils/Leukocytes (%) > 1.2*ULN	1 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Cholesterol (mg/dL) > 1.3*ULN	0 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	URINE Hemoglobin ≥ 1	2 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Prothrombin Time (sec) > 1.1*ULN	0 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Potassium (mEq/L) < 0.9*LLN	1 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Creatinine (mg/dL) > 1.3*ULN	0 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	URINE Leukocytes (Scalar) ≥ 20	0 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Leukocyte Esterase ≥ 1	3 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Bilirubin (mg/dL) > 1.5*ULN	1 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Hyaline Casts (/LPF) > 1	1 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Hemoglobin (g/dL) <0.8*LLN	0 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Lymphocytes/Leukocytes (%) < 0.8*LLN	0 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Reticulocytes/Erythrocytes (%) > 1.5*ULN	0 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Hematocrit (%) < 0.8*LLN	0 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Eosinophils (10^3/mm3) > 1.2*ULN	2 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Aspartate Aminotransferase (U/L) > 3.0*ULN	1 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Erythrocytes (10^6/mm3) < 0.8*LLN	0 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Indirect Bilirubin (mg/dL) > 1.5*ULN	1 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Neutrophils/Leukocytes (%) < 0.8*LLN	2 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Reticulocytes (10^3/mm3) < 0.5*LLN	0 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Alanine Aminotransferase (U/L) > 3.0*ULN	0 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Urate (mg/dL) > 1.2*ULN	1 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Platelets (10^3/mm3) < 0.5*LLN	0 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Eosinophils/Leukocytes (%) > 1.2*ULN	2 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Neutrophils (10^3/mm3) < 0.8*LLN	3 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Leukocytes (10^3/mm3) < 0.6*LLN	0 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Gamma Glutamyl Transferase (U/L) > 3.0*ULN	0 Participants
Abrocitinib 200 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Lymphocytes/Leukocytes (%) > 1.2*ULN	1 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Leukocytes (10^3/mm3) < 0.6*LLN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Bilirubin (mg/dL) > 1.5*ULN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Cholesterol (mg/dL) > 1.3*ULN	1 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Leukocyte Esterase ≥ 1	1 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Lymphocytes (10^3/mm3) < 0.8*LLN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Lymphocytes/Leukocytes (%) < 0.8*LLN	1 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Lymphocytes/Leukocytes (%) > 1.2*ULN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Neutrophils (10^3/mm3) < 0.8*LLN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Neutrophils/Leukocytes (%) < 0.8*LLN	2 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Basophils/Leukocytes (%) > 1.2*ULN	2 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Eosinophils (10^3/mm3) > 1.2*ULN	10 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Eosinophils/Leukocytes (%) > 1.2*ULN	10 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Monocytes (10^3/mm3) > 1.2x ULN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Monocytes/Leukocytes (%) > 1.2*ULN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Prothrombin Time (sec) > 1.1*ULN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Indirect Bilirubin (mg/dL) > 1.5*ULN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Aspartate Aminotransferase (U/L) > 3.0*ULN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Alanine Aminotransferase (U/L) > 3.0*ULN	1 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Gamma Glutamyl Transferase (U/L) > 3.0*ULN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Lactate Dehydrogenase (U/L) > 3.0*ULN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Creatinine (mg/dL) > 1.3*ULN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Urate (mg/dL) > 1.2*ULN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Potassium (mEq/L) < 0.9*LLN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Bicarbonate (mEq/L) > 1.1*ULN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	URINE Hemoglobin ≥ 1	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Creatine Kinase (U/L) > 2.0*ULN	2 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Ketones ≥ 1	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	URINE Protein ≥ 1	1 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	URINE Leukocytes (Scalar) ≥ 20	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Hemoglobin (g/dL) <0.8*LLN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Hematocrit (%) < 0.8*LLN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Erythrocytes (10^6/mm3) < 0.8*LLN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Reticulocytes (10^3/mm3) < 0.5*LLN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Reticulocytes/Erythrocytes (%) > 1.5*ULN	0 Participants
Placebo	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Platelets (10^3/mm3) < 0.5*LLN	0 Participants

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.

Time frame: Baseline to 16 weeks

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Abrocitinib 100 mg QD	Number of Participants With Serious Adverse Events (SAEs)	All-causality SAEs	0 Participants
Abrocitinib 100 mg QD	Number of Participants With Serious Adverse Events (SAEs)	Treatment-related SAEs	0 Participants
Abrocitinib 200 mg QD	Number of Participants With Serious Adverse Events (SAEs)	All-causality SAEs	0 Participants
Abrocitinib 200 mg QD	Number of Participants With Serious Adverse Events (SAEs)	Treatment-related SAEs	0 Participants
Placebo	Number of Participants With Serious Adverse Events (SAEs)	All-causality SAEs	1 Participants
Placebo	Number of Participants With Serious Adverse Events (SAEs)	Treatment-related SAEs	1 Participants

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.

Time frame: Baseline to 16 weeks

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Abrocitinib 100 mg QD	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	All-causality TEAEs	10 Participants
Abrocitinib 100 mg QD	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Treatment-related TEAEs	6 Participants
Abrocitinib 200 mg QD	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	All-causality TEAEs	7 Participants
Abrocitinib 200 mg QD	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Treatment-related TEAEs	5 Participants
Placebo	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	All-causality TEAEs	8 Participants
Placebo	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Treatment-related TEAEs	3 Participants

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.

Time frame: Baseline to Week 2, 4, 8 and 12

Arm	Measure	Group	Value (NUMBER)
Abrocitinib 100 mg QD	Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12	Week 4	66.7 Percentage of participants
Abrocitinib 100 mg QD	Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12	Week 8	53.3 Percentage of participants
Abrocitinib 100 mg QD	Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12	Week 12	68.8 Percentage of participants
Abrocitinib 100 mg QD	Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12	Week 2	37.5 Percentage of participants
Abrocitinib 200 mg QD	Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12	Week 4	100.0 Percentage of participants
Abrocitinib 200 mg QD	Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12	Week 2	61.5 Percentage of participants
Abrocitinib 200 mg QD	Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12	Week 8	100.0 Percentage of participants
Abrocitinib 200 mg QD	Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12	Week 12	92.9 Percentage of participants
Placebo	Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12	Week 2	12.5 Percentage of participants
Placebo	Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12	Week 12	18.8 Percentage of participants
Placebo	Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12	Week 4	6.7 Percentage of participants
Placebo	Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12	Week 8	6.7 Percentage of participants

Secondary

Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12

Time frame: Baseline to Week 2, 4, 8 and 12

Arm	Measure	Group	Value (NUMBER)
Abrocitinib 100 mg QD	Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12	Week 2	0 Percentage of participants
Abrocitinib 100 mg QD	Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12	Week 4	20.0 Percentage of participants
Abrocitinib 100 mg QD	Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12	Week 8	20.0 Percentage of participants
Abrocitinib 100 mg QD	Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12	Week 12	37.5 Percentage of participants
Abrocitinib 200 mg QD	Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12	Week 8	57.1 Percentage of participants
Abrocitinib 200 mg QD	Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12	Week 12	50.0 Percentage of participants
Abrocitinib 200 mg QD	Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12	Week 2	0 Percentage of participants
Abrocitinib 200 mg QD	Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12	Week 4	28.6 Percentage of participants
Placebo	Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12	Week 2	0 Percentage of participants
Placebo	Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12	Week 4	0 Percentage of participants
Placebo	Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12	Week 8	0 Percentage of participants
Placebo	Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12	Week 12	0 Percentage of participants

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.

Time frame: Baseline, Week 2, 4, 8, and 12

Arm	Measure	Group	Value (NUMBER)
Abrocitinib 100 mg QD	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12	Week 2	6.3 Percentage of participants
Abrocitinib 100 mg QD	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12	Week 8	46.7 Percentage of participants
Abrocitinib 100 mg QD	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12	Week 4	46.7 Percentage of participants
Abrocitinib 100 mg QD	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12	Week 12	43.8 Percentage of participants
Abrocitinib 200 mg QD	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12	Week 8	78.6 Percentage of participants
Abrocitinib 200 mg QD	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12	Week 2	38.5 Percentage of participants
Abrocitinib 200 mg QD	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12	Week 4	50.0 Percentage of participants
Abrocitinib 200 mg QD	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12	Week 12	78.6 Percentage of participants
Placebo	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12	Week 4	0 Percentage of participants
Placebo	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12	Week 8	0 Percentage of participants
Placebo	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12	Week 12	0 Percentage of participants
Placebo	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12	Week 2	0 Percentage of participants

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.

Time frame: Baseline, Weeks 2, 4, 8, and 12

Arm	Measure	Group	Value (NUMBER)
Abrocitinib 100 mg QD	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	Week 8	26.7 Percentage of participants
Abrocitinib 100 mg QD	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	Week 2	0 Percentage of participants
Abrocitinib 100 mg QD	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	Week 4	26.7 Percentage of participants
Abrocitinib 100 mg QD	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	Week 12	25.0 Percentage of participants
Abrocitinib 200 mg QD	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	Week 2	7.7 Percentage of participants
Abrocitinib 200 mg QD	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	Week 4	35.7 Percentage of participants
Abrocitinib 200 mg QD	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	Week 8	64.3 Percentage of participants
Abrocitinib 200 mg QD	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	Week 12	57.1 Percentage of participants
Placebo	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	Week 2	0 Percentage of participants
Placebo	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	Week 8	0 Percentage of participants
Placebo	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	Week 4	0 Percentage of participants
Placebo	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	Week 12	0 Percentage of participants

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.

Time frame: Baseline, Week 2, 4, 8, 12

Arm	Measure	Group	Value (NUMBER)
Abrocitinib 100 mg QD	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	Week 2	25.0 Percentage of participants
Abrocitinib 100 mg QD	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	Week 4	53.3 Percentage of participants
Abrocitinib 100 mg QD	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	Week 8	46.7 Percentage of participants
Abrocitinib 100 mg QD	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	Week 12	35.7 Percentage of participants
Abrocitinib 200 mg QD	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	Week 12	64.3 Percentage of participants
Abrocitinib 200 mg QD	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	Week 2	57.1 Percentage of participants
Abrocitinib 200 mg QD	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	Week 8	64.3 Percentage of participants
Abrocitinib 200 mg QD	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	Week 4	64.3 Percentage of participants
Placebo	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	Week 12	6.3 Percentage of participants
Placebo	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	Week 4	0 Percentage of participants
Placebo	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	Week 8	13.3 Percentage of participants
Placebo	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	Week 2	6.3 Percentage of participants

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.

Time frame: Baseline and Week 2, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Abrocitinib 100 mg QD	Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12	Week 2	-9.6 Percent change	Standard Deviation 12.06
Abrocitinib 100 mg QD	Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12	Week 4	-18.7 Percent change	Standard Deviation 15.7
Abrocitinib 100 mg QD	Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12	Week 8	-18.7 Percent change	Standard Deviation 20.96
Abrocitinib 100 mg QD	Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12	Week 12	-22.0 Percent change	Standard Deviation 19.03
Abrocitinib 200 mg QD	Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12	Week 12	-28.3 Percent change	Standard Deviation 16.95
Abrocitinib 200 mg QD	Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12	Week 2	-17.3 Percent change	Standard Deviation 13.78
Abrocitinib 200 mg QD	Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12	Week 8	-28.3 Percent change	Standard Deviation 16.84
Abrocitinib 200 mg QD	Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12	Week 4	-23.8 Percent change	Standard Deviation 14.19
Placebo	Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12	Week 12	-0.2 Percent change	Standard Deviation 23.2
Placebo	Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12	Week 4	2.1 Percent change	Standard Deviation 18.35
Placebo	Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12	Week 8	0.2 Percent change	Standard Deviation 21.59
Placebo	Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12	Week 2	4.0 Percent change	Standard Deviation 17.25

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).

Time frame: Baseline, Week 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Abrocitinib 100 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	T lymphocytes CD3+CD8 (absolute)	-15.1 Percent change	Standard Deviation 22.19
Abrocitinib 100 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	T lymphocytes CD3+CD4 (absolute)	-13.2 Percent change	Standard Deviation 20.06
Abrocitinib 100 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	B-cells TBNK Screening (%)	35.5 Percent change	Standard Deviation 41.18
Abrocitinib 100 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	T-cells TBNK Screening (absolute)	-14.5 Percent change	Standard Deviation 19.5
Abrocitinib 100 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	T-cells TBNK Screening (%)	-0.2 Percent change	Standard Deviation 5.25
Abrocitinib 100 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	T lymphocytes CD3+CD4 (%)	1.4 Percent change	Standard Deviation 7.18
Abrocitinib 100 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	NK Cells TBNK Screening (%)	-27.3 Percent change	Standard Deviation 40.12
Abrocitinib 100 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	T lymphocytes CD3+CD8 (%)	-0.7 Percent change	Standard Deviation 12.22
Abrocitinib 100 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	NK Cells TBNK Screening (absolute)	-40.0 Percent change	Standard Deviation 29.41
Abrocitinib 100 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	B-cells TBNK Screening (absolute)	18.3 Percent change	Standard Deviation 52.71
Abrocitinib 200 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	NK Cells TBNK Screening (absolute)	-53.2 Percent change	Standard Deviation 26.96
Abrocitinib 200 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	T lymphocytes CD3+CD4 (%)	6.7 Percent change	Standard Deviation 11.73
Abrocitinib 200 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	T lymphocytes CD3+CD4 (absolute)	17.1 Percent change	Standard Deviation 41.66
Abrocitinib 200 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	T lymphocytes CD3+CD8 (%)	3.2 Percent change	Standard Deviation 10.59
Abrocitinib 200 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	T lymphocytes CD3+CD8 (absolute)	16.2 Percent change	Standard Deviation 54.75
Abrocitinib 200 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	T-cells TBNK Screening (%)	3.6 Percent change	Standard Deviation 6.65
Abrocitinib 200 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	T-cells TBNK Screening (absolute)	14.2 Percent change	Standard Deviation 43.43
Abrocitinib 200 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	B-cells TBNK Screening (%)	42.4 Percent change	Standard Deviation 37.49
Abrocitinib 200 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	B-cells TBNK Screening (absolute)	55.0 Percent change	Standard Deviation 59.81
Abrocitinib 200 mg QD	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	NK Cells TBNK Screening (%)	-55.9 Percent change	Standard Deviation 24.04
Placebo	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	NK Cells TBNK Screening (%)	-15.2 Percent change	Standard Deviation 28.64
Placebo	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	T-cells TBNK Screening (absolute)	1.5 Percent change	Standard Deviation 29.1
Placebo	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	B-cells TBNK Screening (%)	7.8 Percent change	Standard Deviation 23.69
Placebo	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	T lymphocytes CD3+CD8 (%)	-1.6 Percent change	Standard Deviation 8.75
Placebo	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	T lymphocytes CD3+CD4 (%)	5.6 Percent change	Standard Deviation 7.96
Placebo	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	B-cells TBNK Screening (absolute)	7.7 Percent change	Standard Deviation 39.19
Placebo	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	T-cells TBNK Screening (%)	1.7 Percent change	Standard Deviation 3.69
Placebo	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	NK Cells TBNK Screening (absolute)	-17.9 Percent change	Standard Deviation 26.81
Placebo	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	T lymphocytes CD3+CD4 (absolute)	5.2 Percent change	Standard Deviation 29.79
Placebo	Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12	T lymphocytes CD3+CD8 (absolute)	-1.1 Percent change	Standard Deviation 33.17

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.

Time frame: Baseline, Week 12

Population: 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.

Arm	Measure	Group	Value (NUMBER)
Abrocitinib 100 mg QD	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	CD11C	0.242 Spearman correlation coefficient
Abrocitinib 100 mg QD	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	KRT16	0.313 Spearman correlation coefficient
Abrocitinib 100 mg QD	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	S100A9	0.390 Spearman correlation coefficient
Abrocitinib 100 mg QD	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	CCL18	0.395 Spearman correlation coefficient
Abrocitinib 100 mg QD	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	S100A12	0.238 Spearman correlation coefficient
Abrocitinib 100 mg QD	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	Macrophage mannose receptor 1	0.396 Spearman correlation coefficient
Abrocitinib 100 mg QD	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	FC Epsilon R1	0.474 Spearman correlation coefficient
Abrocitinib 100 mg QD	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	S100A8	0.365 Spearman correlation coefficient
Abrocitinib 100 mg QD	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	CD3	0.438 Spearman correlation coefficient
Abrocitinib 200 mg QD	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	CD3	0.408 Spearman correlation coefficient
Abrocitinib 200 mg QD	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	Macrophage mannose receptor 1	0.162 Spearman correlation coefficient
Abrocitinib 200 mg QD	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	S100A9	0.529 Spearman correlation coefficient
Abrocitinib 200 mg QD	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	S100A8	0.510 Spearman correlation coefficient
Abrocitinib 200 mg QD	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	KRT16	0.486 Spearman correlation coefficient
Abrocitinib 200 mg QD	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	S100A12	0.454 Spearman correlation coefficient
Abrocitinib 200 mg QD	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	CCL18	0.410 Spearman correlation coefficient
Abrocitinib 200 mg QD	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	CD11C	0.484 Spearman correlation coefficient
Abrocitinib 200 mg QD	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	FC Epsilon R1	0.464 Spearman correlation coefficient
Placebo	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	CCL18	0.365 Spearman correlation coefficient
Placebo	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	S100A8	0.413 Spearman correlation coefficient
Placebo	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	Macrophage mannose receptor 1	-0.134 Spearman correlation coefficient
Placebo	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	CD11C	0.439 Spearman correlation coefficient
Placebo	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	S100A9	0.334 Spearman correlation coefficient
Placebo	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	CD3	0.151 Spearman correlation coefficient
Placebo	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	S100A12	0.460 Spearman correlation coefficient
Placebo	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	KRT16	0.522 Spearman correlation coefficient
Placebo	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	FC Epsilon R1	0.238 Spearman correlation coefficient

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.

Time frame: Baseline and Week 2, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Abrocitinib 100 mg QD	Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12	Week 8	-0.21 10^6 cells/mm^3	Standard Deviation 0.301
Abrocitinib 100 mg QD	Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12	Week 4	-0.16 10^6 cells/mm^3	Standard Deviation 0.279
Abrocitinib 100 mg QD	Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12	Week 12	-0.35 10^6 cells/mm^3	Standard Deviation 0.376
Abrocitinib 100 mg QD	Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12	Week 2	-0.12 10^6 cells/mm^3	Standard Deviation 0.212
Abrocitinib 200 mg QD	Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12	Week 8	-0.35 10^6 cells/mm^3	Standard Deviation 0.424
Abrocitinib 200 mg QD	Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12	Week 4	-0.19 10^6 cells/mm^3	Standard Deviation 0.266
Abrocitinib 200 mg QD	Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12	Week 12	-0.47 10^6 cells/mm^3	Standard Deviation 0.434
Abrocitinib 200 mg QD	Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12	Week 2	-0.21 10^6 cells/mm^3	Standard Deviation 0.305
Placebo	Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12	Week 12	0.07 10^6 cells/mm^3	Standard Deviation 0.183
Placebo	Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12	Week 4	-0.11 10^6 cells/mm^3	Standard Deviation 0.274
Placebo	Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12	Week 8	-0.02 10^6 cells/mm^3	Standard Deviation 0.246
Placebo	Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12	Week 2	-0.10 10^6 cells/mm^3	Standard Deviation 0.242

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.

Time frame: Baseline and Week 2, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Abrocitinib 100 mg QD	Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12	Week 8	7.84 milliunits per milliliter	Standard Deviation 8.305
Abrocitinib 100 mg QD	Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12	Week 2	5.38 milliunits per milliliter	Standard Deviation 7.042
Abrocitinib 100 mg QD	Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12	Week 4	5.30 milliunits per milliliter	Standard Deviation 6.286
Abrocitinib 100 mg QD	Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12	Week 12	7.86 milliunits per milliliter	Standard Deviation 15.831
Abrocitinib 200 mg QD	Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12	Week 12	54.08 milliunits per milliliter	Standard Deviation 136.613
Abrocitinib 200 mg QD	Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12	Week 4	14.60 milliunits per milliliter	Standard Deviation 30.438
Abrocitinib 200 mg QD	Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12	Week 2	15.78 milliunits per milliliter	Standard Deviation 29.596
Abrocitinib 200 mg QD	Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12	Week 8	34.12 milliunits per milliliter	Standard Deviation 58.113
Placebo	Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12	Week 2	0.59 milliunits per milliliter	Standard Deviation 7.412
Placebo	Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12	Week 8	-1.99 milliunits per milliliter	Standard Deviation 8.101
Placebo	Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12	Week 12	-3.11 milliunits per milliliter	Standard Deviation 6.391
Placebo	Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12	Week 4	0.35 milliunits per milliliter	Standard Deviation 8.294

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.

Time frame: Baseline and Week 2, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Abrocitinib 100 mg QD	Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12	Week 4	-0.24 milligrams per deciliter	Standard Deviation 0.376
Abrocitinib 100 mg QD	Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12	Week 12	-0.15 milligrams per deciliter	Standard Deviation 0.368
Abrocitinib 100 mg QD	Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12	Week 8	-0.19 milligrams per deciliter	Standard Deviation 0.287
Abrocitinib 100 mg QD	Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12	Week 2	-0.26 milligrams per deciliter	Standard Deviation 0.431
Abrocitinib 200 mg QD	Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12	Week 2	-0.07 milligrams per deciliter	Standard Deviation 0.147
Abrocitinib 200 mg QD	Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12	Week 4	-0.09 milligrams per deciliter	Standard Deviation 0.217
Abrocitinib 200 mg QD	Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12	Week 12	0.01 milligrams per deciliter	Standard Deviation 0.254
Abrocitinib 200 mg QD	Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12	Week 8	0.03 milligrams per deciliter	Standard Deviation 0.253
Placebo	Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12	Week 12	-0.40 milligrams per deciliter	Standard Deviation 1.114
Placebo	Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12	Week 4	-0.43 milligrams per deciliter	Standard Deviation 1.283
Placebo	Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12	Week 8	-0.42 milligrams per deciliter	Standard Deviation 1.182
Placebo	Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12	Week 2	-0.13 milligrams per deciliter	Standard Deviation 1.538

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.

Time frame: Baseline and Week 2, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Abrocitinib 100 mg QD	Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12	Week 2	-0.02 picograms per milliliter	Standard Deviation 2.732
Abrocitinib 100 mg QD	Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12	Week 8	0.19 picograms per milliliter	Standard Deviation 1.391
Abrocitinib 100 mg QD	Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12	Week 12	-0.23 picograms per milliliter	Standard Deviation 2.712
Abrocitinib 100 mg QD	Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12	Week 4	0.16 picograms per milliliter	Standard Deviation 2.533
Abrocitinib 200 mg QD	Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12	Week 4	-0.85 picograms per milliliter	Standard Deviation 5.045
Abrocitinib 200 mg QD	Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12	Week 2	-0.11 picograms per milliliter	Standard Deviation 7.021
Abrocitinib 200 mg QD	Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12	Week 12	-0.19 picograms per milliliter	Standard Deviation 5.305
Abrocitinib 200 mg QD	Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12	Week 8	0.15 picograms per milliliter	Standard Deviation 5.728
Placebo	Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12	Week 12	-2.59 picograms per milliliter	Standard Deviation 6.339
Placebo	Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12	Week 8	-3.52 picograms per milliliter	Standard Deviation 8.228
Placebo	Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12	Week 2	-0.44 picograms per milliliter	Standard Deviation 2.797
Placebo	Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12	Week 4	-1.83 picograms per milliliter	Standard Deviation 6.034

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.

Time frame: Baseline and Week 2, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Abrocitinib 100 mg QD	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Severity of Night Time Itch Week 12	-3.4 Units on a scale	Standard Deviation 3.8
Abrocitinib 100 mg QD	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Severity of Night Time Itch Week 4	-4.4 Units on a scale	Standard Deviation 3.38
Abrocitinib 100 mg QD	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Frequency of Night Time Itch Week 12	-1.2 Units on a scale	Standard Deviation 1.21
Abrocitinib 100 mg QD	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Severity of Night Time Itch Week 2	-2.4 Units on a scale	Standard Deviation 2.16
Abrocitinib 100 mg QD	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Frequency of Night Time Itch Week 2	-0.8 Units on a scale	Standard Deviation 0.91
Abrocitinib 100 mg QD	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Frequency of Night Time Itch Week 4	-1.8 Units on a scale	Standard Deviation 1.08
Abrocitinib 100 mg QD	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Severity of Night Time Itch Week 8	-3.5 Units on a scale	Standard Deviation 4.14
Abrocitinib 100 mg QD	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Frequency of Night Time Itch Week 8	-1.4 Units on a scale	Standard Deviation 1.35
Abrocitinib 200 mg QD	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Frequency of Night Time Itch Week 12	-2.5 Units on a scale	Standard Deviation 1.45
Abrocitinib 200 mg QD	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Severity of Night Time Itch Week 12	-4.8 Units on a scale	Standard Deviation 3.77
Abrocitinib 200 mg QD	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Frequency of Night Time Itch Week 4	-2.5 Units on a scale	Standard Deviation 1.09
Abrocitinib 200 mg QD	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Frequency of Night Time Itch Week 8	-2.7 Units on a scale	Standard Deviation 1.14
Abrocitinib 200 mg QD	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Severity of Night Time Itch Week 4	-4.9 Units on a scale	Standard Deviation 3.52
Abrocitinib 200 mg QD	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Severity of Night Time Itch Week 8	-5.5 Units on a scale	Standard Deviation 3.52
Abrocitinib 200 mg QD	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Frequency of Night Time Itch Week 2	-2.1 Units on a scale	Standard Deviation 1.14
Abrocitinib 200 mg QD	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Severity of Night Time Itch Week 2	-4.6 Units on a scale	Standard Deviation 2.79
Placebo	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Frequency of Night Time Itch Week 4	-0.6 Units on a scale	Standard Deviation 1.12
Placebo	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Frequency of Night Time Itch Week 2	-0.2 Units on a scale	Standard Deviation 1.08
Placebo	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Severity of Night Time Itch Week 8	-0.8 Units on a scale	Standard Deviation 2.85
Placebo	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Severity of Night Time Itch Week 12	-1.1 Units on a scale	Standard Deviation 2.46
Placebo	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Frequency of Night Time Itch Week 12	-0.4 Units on a scale	Standard Deviation 1.22
Placebo	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Frequency of Night Time Itch Week 8	-0.6 Units on a scale	Standard Deviation 1.39
Placebo	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Severity of Night Time Itch Week 2	-0.3 Units on a scale	Standard Deviation 1.83
Placebo	Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12	NRS01-Severity of Night Time Itch Week 4	-1.1 Units on a scale	Standard Deviation 2.53

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.

Time frame: Baseline and Week 2, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Abrocitinib 100 mg QD	Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12	Week 8	-68.15 10^3 cells/mm^3	Standard Deviation 102.846
Abrocitinib 100 mg QD	Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12	Week 12	-59.00 10^3 cells/mm^3	Standard Deviation 104.408
Abrocitinib 100 mg QD	Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12	Week 4	-89.79 10^3 cells/mm^3	Standard Deviation 123.18
Abrocitinib 100 mg QD	Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12	Week 2	-72.86 10^3 cells/mm^3	Standard Deviation 93.413
Abrocitinib 200 mg QD	Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12	Week 8	-71.38 10^3 cells/mm^3	Standard Deviation 44.925
Abrocitinib 200 mg QD	Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12	Week 2	-53.23 10^3 cells/mm^3	Standard Deviation 28.176
Abrocitinib 200 mg QD	Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12	Week 12	-65.79 10^3 cells/mm^3	Standard Deviation 42.6
Abrocitinib 200 mg QD	Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12	Week 4	-93.29 10^3 cells/mm^3	Standard Deviation 36.123
Placebo	Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12	Week 12	5.47 10^3 cells/mm^3	Standard Deviation 34.62
Placebo	Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12	Week 4	11.79 10^3 cells/mm^3	Standard Deviation 33.025
Placebo	Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12	Week 2	12.87 10^3 cells/mm^3	Standard Deviation 51.582
Placebo	Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12	Week 8	5.79 10^3 cells/mm^3	Standard Deviation 28.917

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.

Time frame: Baseline and Week 2, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Abrocitinib 100 mg QD	Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12	Week 8	-9.31 10^3 cells/mm^3	Standard Deviation 15.997
Abrocitinib 100 mg QD	Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12	Week 4	-11.64 10^3 cells/mm^3	Standard Deviation 27.845
Abrocitinib 100 mg QD	Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12	Week 2	-15.43 10^3 cells/mm^3	Standard Deviation 23.177
Abrocitinib 100 mg QD	Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12	Week 12	-5.07 10^3 cells/mm^3	Standard Deviation 16.615
Abrocitinib 200 mg QD	Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12	Week 4	-20.86 10^3 cells/mm^3	Standard Deviation 28.71
Abrocitinib 200 mg QD	Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12	Week 2	-25.14 10^3 cells/mm^3	Standard Deviation 28.057
Abrocitinib 200 mg QD	Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12	Week 8	-13.23 10^3 cells/mm^3	Standard Deviation 18.682
Abrocitinib 200 mg QD	Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12	Week 12	-7.64 10^3 cells/mm^3	Standard Deviation 28.169
Placebo	Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12	Week 8	0.07 10^3 cells/mm^3	Standard Deviation 15.345
Placebo	Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12	Week 4	1.86 10^3 cells/mm^3	Standard Deviation 16.209
Placebo	Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12	Week 2	5.33 10^3 cells/mm^3	Standard Deviation 12.199
Placebo	Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12	Week 12	4.33 10^3 cells/mm^3	Standard Deviation 20.318

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.

Time frame: Baseline and Week 2, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Abrocitinib 100 mg QD	Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12	Week 12	30.93 Picograms per milliliter (pg/mL)	Standard Deviation 53.723
Abrocitinib 100 mg QD	Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12	Week 4	107.93 Picograms per milliliter (pg/mL)	Standard Deviation 274.324
Abrocitinib 100 mg QD	Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12	Week 2	38.33 Picograms per milliliter (pg/mL)	Standard Deviation 61.921
Abrocitinib 100 mg QD	Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12	Week 8	26.93 Picograms per milliliter (pg/mL)	Standard Deviation 49.26
Abrocitinib 200 mg QD	Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12	Week 4	103.07 Picograms per milliliter (pg/mL)	Standard Deviation 136.964
Abrocitinib 200 mg QD	Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12	Week 8	76.54 Picograms per milliliter (pg/mL)	Standard Deviation 116.433
Abrocitinib 200 mg QD	Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12	Week 12	89.57 Picograms per milliliter (pg/mL)	Standard Deviation 201.7
Abrocitinib 200 mg QD	Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12	Week 2	47.64 Picograms per milliliter (pg/mL)	Standard Deviation 38.472
Placebo	Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12	Week 12	-7.00 Picograms per milliliter (pg/mL)	Standard Deviation 30.166
Placebo	Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12	Week 2	13.29 Picograms per milliliter (pg/mL)	Standard Deviation 31.665
Placebo	Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12	Week 8	4.57 Picograms per milliliter (pg/mL)	Standard Deviation 33.073
Placebo	Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12	Week 4	-9.36 Picograms per milliliter (pg/mL)	Standard Deviation 31.03

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.

Time frame: Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Abrocitinib 100 mg QD	Plasma PF-04965842 Concentration	Day 29 Hour 0	14.77 nanogram per milliliter (ng/mL)	Standard Deviation 29.293
Abrocitinib 100 mg QD	Plasma PF-04965842 Concentration	Day 29 30 minute	266.6 nanogram per milliliter (ng/mL)	Standard Deviation 381.11
Abrocitinib 100 mg QD	Plasma PF-04965842 Concentration	Day 85 30 minute	617.6 nanogram per milliliter (ng/mL)	Standard Deviation 588.85
Abrocitinib 100 mg QD	Plasma PF-04965842 Concentration	Day 85 Hour 4	433.0 nanogram per milliliter (ng/mL)	Standard Deviation 255.44
Abrocitinib 200 mg QD	Plasma PF-04965842 Concentration	Day 85 Hour 4	1147 nanogram per milliliter (ng/mL)	Standard Deviation 580.56
Abrocitinib 200 mg QD	Plasma PF-04965842 Concentration	Day 29 Hour 0	135.7 nanogram per milliliter (ng/mL)	Standard Deviation 272.53
Abrocitinib 200 mg QD	Plasma PF-04965842 Concentration	Day 85 30 minute	792.2 nanogram per milliliter (ng/mL)	Standard Deviation 1013.9
Abrocitinib 200 mg QD	Plasma PF-04965842 Concentration	Day 29 30 minute	802.7 nanogram per milliliter (ng/mL)	Standard Deviation 1128.2

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).

Time frame: Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose

Arm	Measure	Group	Value (MEAN)	Dispersion
Abrocitinib 100 mg QD	Plasma PF-06471658 (M1) Concentration	Day 29 Hour 0	2.588 ng/mL	Standard Deviation 3.4071
Abrocitinib 100 mg QD	Plasma PF-06471658 (M1) Concentration	Day 29 30 minute	65.82 ng/mL	Standard Deviation 137.66
Abrocitinib 100 mg QD	Plasma PF-06471658 (M1) Concentration	Day 85 30 minute	92.51 ng/mL	Standard Deviation 80.717
Abrocitinib 100 mg QD	Plasma PF-06471658 (M1) Concentration	Day 85 Hour 4	82.84 ng/mL	Standard Deviation 70.532
Abrocitinib 200 mg QD	Plasma PF-06471658 (M1) Concentration	Day 85 Hour 4	104.9 ng/mL	Standard Deviation 80.782
Abrocitinib 200 mg QD	Plasma PF-06471658 (M1) Concentration	Day 29 Hour 0	23.13 ng/mL	Standard Deviation 47.649
Abrocitinib 200 mg QD	Plasma PF-06471658 (M1) Concentration	Day 85 30 minute	65.03 ng/mL	Standard Deviation 51.765
Abrocitinib 200 mg QD	Plasma PF-06471658 (M1) Concentration	Day 29 30 minute	95.54 ng/mL	Standard Deviation 108.21

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).

Time frame: Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose

Arm	Measure	Group	Value (MEAN)	Dispersion
Abrocitinib 100 mg QD	Plasma PF-07054874 (M4) Concentration	Day 29 Hour 0	16.10 ng/mL	Standard Deviation 33.537
Abrocitinib 100 mg QD	Plasma PF-07054874 (M4) Concentration	Day 29 30 minute	63.76 ng/mL	Standard Deviation 80.663
Abrocitinib 100 mg QD	Plasma PF-07054874 (M4) Concentration	Day 85 30 minute	149.9 ng/mL	Standard Deviation 126.33
Abrocitinib 100 mg QD	Plasma PF-07054874 (M4) Concentration	Day 85 Hour 4	170.4 ng/mL	Standard Deviation 68.419
Abrocitinib 200 mg QD	Plasma PF-07054874 (M4) Concentration	Day 85 Hour 4	268.2 ng/mL	Standard Deviation 173.11
Abrocitinib 200 mg QD	Plasma PF-07054874 (M4) Concentration	Day 29 Hour 0	48.43 ng/mL	Standard Deviation 83.563
Abrocitinib 200 mg QD	Plasma PF-07054874 (M4) Concentration	Day 85 30 minute	158.2 ng/mL	Standard Deviation 174.55
Abrocitinib 200 mg QD	Plasma PF-07054874 (M4) Concentration	Day 29 30 minute	153.4 ng/mL	Standard Deviation 163.23

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).

Time frame: Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose

Arm	Measure	Group	Value (MEAN)	Dispersion
Abrocitinib 100 mg QD	Plasma PF-07055087 (M2) Concentration	Day 29 Hour 0	9.933 ng/mL	Standard Deviation 22.629
Abrocitinib 100 mg QD	Plasma PF-07055087 (M2) Concentration	Day 29 30 minute	42.89 ng/mL	Standard Deviation 66.789
Abrocitinib 100 mg QD	Plasma PF-07055087 (M2) Concentration	Day 85 30 minute	77.56 ng/mL	Standard Deviation 63.483
Abrocitinib 100 mg QD	Plasma PF-07055087 (M2) Concentration	Day 85 Hour 4	100.0 ng/mL	Standard Deviation 46.321
Abrocitinib 200 mg QD	Plasma PF-07055087 (M2) Concentration	Day 85 Hour 4	132.9 ng/mL	Standard Deviation 69.048
Abrocitinib 200 mg QD	Plasma PF-07055087 (M2) Concentration	Day 29 Hour 0	23.86 ng/mL	Standard Deviation 40.798
Abrocitinib 200 mg QD	Plasma PF-07055087 (M2) Concentration	Day 85 30 minute	70.58 ng/mL	Standard Deviation 67.136
Abrocitinib 200 mg QD	Plasma PF-07055087 (M2) Concentration	Day 29 30 minute	73.84 ng/mL	Standard Deviation 75.245

Source: ClinicalTrials.gov · Data processed: Aug 3, 2026

Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12

Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12

Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12

Fold-Change From Baseline in Epidermal Hyperplasia Markers in Skin Biopsies and Skin Thickness at Week 12

Number of Participants Who Discontinued From the Study Due to TEAEs

Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

Number of Participants With Serious Adverse Events (SAEs)

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12

Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12

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

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

Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12

Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12

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

Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12

Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12

Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12

Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12

Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12

Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12

Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12

Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12

Plasma PF-04965842 Concentration

Plasma PF-06471658 (M1) Concentration

Plasma PF-07054874 (M4) Concentration

Plasma PF-07055087 (M2) Concentration