Table 1.

Clinical Trials Evaluating Efficacy and Safety of Abrocitinib in Atopic Dermatitis

Trial	Title	Phase	Enrollment	Arm	Primary Outcomes	Main Secondary Outcomes	Status
NCT01835197	First-in-Human Study to Evaluate Safety and Tolerability of Single and Multiple Ascending Doses of Janus Kinase-1 Inhibitor PF-04965842 in Healthy Western and Japanese Subjects	1	Patients	-Single doses of 3, 10, 30, 100, 200, 400, or 800 mg of abrocitinib in a dose escalation format; -single doses of abrocitinib matching placebo in a dose escalation format; -doses of 30, 100 or 200 mg QD for 10 days; Abrocitinib matching placebo QD for 10 days; -doses of 100 or 200 mg BID for 10 days; -abrocitinib matching placebo doses BID for 10 days; -200 mg dose BID for 10 days; -abrocitinib matching placebo dose BID for 10 days; -400 mg dose QD for 10 days.	Changes from baseline to week 6 in vital signs; Changes from baseline to week in ECG parameters; Incidence of AE; Incidence of clinical laboratory abnormalities; 24-hour urine creatinine clearance;	Complement Level (C3, C4, C3A); neutrophils count; reticulocytes count Apparent total body clearance; urinary pharmacokinetics; renal clearance; plasma decay half-life; maximum observed plasma concentration; apparent volume of distribution	Completed
NCT02780167	A Phase 2b Randomized, Double-Blind, Placebo-controlled, Parallel, Multicenter, Dose Ranging, Study to Evaluate the Efficacy and Safety Profile of PF-04965842 in Subjects with Moderate-to-Severe Atopic Dermatitis	2	267 adult patients aged 18–75 years	-Abrocitinib 10 mg QD -Abrocitinib 30 mg QD; -abrocitinib 100 mg QD; -abrocitinib 200 mg QD; -placebo QD	Proportion of patients achieving IGA score for clear or almost clear and [2-point improvement from baseline at week 12	Variation rate from baseline to week 12 in EASI, BSA, SCORAD and P-NRS	Completed
NCT03349060	Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis (JADE Mono-1)	3	387 patients aged ≥12 years	-Abrocitinib100 mg QD (135 patients); -abrocitinib 200 mg QD (137 patients); -placebo QD (61 patients)	-Proportion of patients who had achieved an IGA score of 1 or 0 with a ≥2-grade improvement form baseline to week 12 -Proportion of patients achieving EASI75 at week 12	-Improvement in P-NRS response ≥4 point and in the SCORAD score. (≥75% or more); -change in DLQI from baseline to week 12;	Completed
NCT03575871	Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis (JADE Mono-2)	3	391 patients aged ≥12 years	-Abrocitinib 100 mg QD; -abrocitinib 200 mg QD; -placebo QD	-The proportion of subjects the at 12 weeks reaching IGA 0/1 or with an improvement of ≥2 grades from baseline; -The proportion of subjects reaching EASI-75 response	-The proportion of subjects with an improvement of ≥4 points in P-NRS score from baseline to week 12 -The change from baseline to week 12 in AD-PSA; -change in BSA from baseline to week 12; -change in SCORAD from baseline to week 12; -change in DLQI from baseline to week 12;	Completed
NCT03720470	Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy (JADE Compare)	3	838 patients aged 18–75 years	-Abrocitinib 100 mg + placebo injection followed by abrocitinib 100 mg; -abrocitinib 200 mg + placebo injection followed by abrocitinib 200mg; -dupilumab injection + oral placebo followed by oral placebo; -oral placebo + placebo injection followed by 100 mg abrocitinib; -oral placebo + placebo injection followed by 200 mg abrocitinib;	-The proportion of subjects the at 12 weeks reaching IGA 0/1 or with an improvement of ≥2 grades from baseline; -The proportion of subjects reaching EASI-75 response	-The proportion of subjects with an improvement of ≥4 points in P-NRS score from baseline to week 12; -change in BSA from baseline to week 12; -change in SCORAD from baseline to week 12; -change in DLQI from baseline to week 12;	Completed
NCT03627767	Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects	3	1234 subjects aged ≥12 years	-Abrocitinib 100 mg, administered as two tablets to be taken orally QD; -abrocitinib 200 mg, administered as two tablets to be taken orally QD; -placebo administered as two tablets to be taken orally QD;	Percentage of patients with a loss of response to abrocitinib (defined as a loss of at least 50% of the EASI) at week 12	- Change in IGA from baseline to week 12; -change in EASI score from baseline to week 12; -change in SCORAD score from baseline to week 12; -change in BSA score from baseline to week 12; -change in DLQI score from baseline to week 12; - the proportion of subjects with an improvement of ≥4 points in P-NRS score from baseline to week 12	Completed but result no posted
NCT03422822	Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis (JADE EXTEND)	3	3000 subjects aged ≥12 years	-Abrocitinib 100 mg QD; -abrocitinib 200 mg QD	-Incidence of AEs during the blinded phase of the study and until availability of commercial product; -Changes from baseline in clinical laboratory values; -Changes from baseline in electrocardiogram measurements; -Changes from baseline in vital signs.	- Change in IGA from baseline to week 92; -change in EASI score from baseline to week 92; -change in SCORAD score from baseline to week 92; -change in BSA score from baseline to week 92; -change in DLQI score from baseline to week 92; - the proportion of subjects with an improvement of ≥4 points in P-NRS score from baseline to week 92	Enrolling by invitation
NCT04345367	Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy	3b	600 patients aged ≥18 years	- Abrocitinib 200 mg plus placebo injection; - dupilumab 300 mg plus placebo tablets	-Change percentage in P-NRS from baseline to week 4 (Response based on achieving at least a 4-point improvement); -change percentage in EASI values from baseline to week 4	-Percentage of patients achieving EASI90 (≥90% improvement from baseline) at week 16; -percentage of participants achieving EASI75 at week 16; -ercentage of patients achieving IGA 0/1 or with a reduction from baseline of ≥2 points at all scheduled time points; -percentage of subjects with at least a 4-point improvement in the severity of P-NRS; -percentage reduction of BSA	Recruiting
NCT04564755	Abrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis	3	Approximately 500 patients aged ≥ 12 years	-Abrocitinib 100 mg QD; -abrocitinib 200 mg QD	No posted	No posted	Available
NCT03915496	Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis (JADE MOA)	2A	51 adult patients aged ≥18 years	-Abrocitinib 100 mg QD; -abrocitinib 200 mg QD; -placebo QD	Changes from baseline in atopic dermatitis biomarkers in lesional and non-lesional skin	-Changes in gene expression from baseline to week 12; -changes in T-cell and dendritic cell inflammation markers from baseline to week 12; -changes in in epidermal hyperplasia markers; -changes in T-cell lymphocyte subset populations from baseline to week 12; -changes from baseline in pruritus and its correlation to immunohistochemistry and genetic markers from baseline to week 12.	Recruiting

Abbreviations: QD, once daily; BID, twice daily; AEs, adverse event; IGA, Investigator’s Global Assessment; EASI, Eczema Area and Severity Index; BSA, body surface area; SCORAD, Scoring Atopic Dermatitis; P-NRS, Pruritus Numerical Rating Scale; PSA, Pruritus and Symptoms Assessment; DLQI, Dermatology Life Quality Index; Inj, injective.