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Abrocitinib

Phase 3

Atopic Dermatitis | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Apr 7, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment1,427
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06807281A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe EczemaPHASE3 RECRUITING 500Dec 2, 2025Feb 22, 2032Apr 7, 202631 United States, China +6
NCT05375929A Study to Learn About Abrocitinib Tablets in People With Atopic Dermatitis in IndiaPHASE3 COMPLETED 200Jul 16, 2022Mar 14, 2024Oct 15, 202415 India
NCT04345367Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical TherapyPHASE3 COMPLETED 727Jun 11, 2020Jul 13, 2021Jul 8, 2022151 United States, Australia +13
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Study Endpoints
Primary Endpoints
Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events (AEs) that lead to study discontinuation
0-24 months

The number of the treatment emergent adverse events, serious adverse events and adverse events leading to discontinuation among patients with moderate-to-severe disease treated with abrocitinib regardless of discontinuation from study treatment.

Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs): Main Study
From Day 1 of dosing up to 4 weeks post last dose (maximum up to Week 16)

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other situations where medical or scientific judgement should be exercised by investigator. AEs included SAEs and all non-SAEs.

Percentage of Participants Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) From Baseline at Week 2
Week 2

The severity of itch (pruritus) due to atopic dermatitis (AD) was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4
Week 4

EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.

Secondary Endpoints
Number of Participants With Clinically Significant Laboratory Abnormalities
0-24 months
Response based on achieving Validated Investigator's Global Assessment (vIGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a 2 -point reduction from baseline at all scheduled time points
Baseline, 24 months
Percentage of Response based on achieving a ≥4 point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS) at all scheduled time points in participants aged ≥2 to <6 years
0-24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ExtensionEXPERIMENTALPatients who have completed other abrocitinib studies
De novoEXPERIMENTALPatients who have not participated other abrocitinib studies
Abrocitinib 100 mgEXPERIMENTALParticipants will receive abrocitinib 100 mg by mouth (QD).
Abrocitinib 200 mgEXPERIMENTALParticipants will receive abrocitinib 200 mg QD.
Abrocitinib 200 mg plus placebo injectionEXPERIMENTALAbrocitinib 200 mg daily through Week 26, plus placebo injections every other week through Week 24
Dupilumab 300 mg plus placebo tabletsACTIVE_COMPARATORDupilumab 300 mg every other week (2 injections on Day 1) through Week 24, plus placebo tablets daily through Week 26
Interventions
NameTypeDescription
AbrocitinibDRUGAbrocitinib administered as liquid oral suspension.
Abrocitinib 100 mgDRUGOrally administered, abrocitinib 100 mg tablets QD
Abrocitinib 200 mgDRUGOrally administered, abrocitinib 200 mg tablets QD.
Dupilumab 300 mgCOMBINATION_PRODUCTDupilumab 300 mg administered as a single subcutaneous injection every other week for 24 weeks (2 injections on day 1). Placebo tablets will be administered daily.
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Eligibility Criteria
Age Range2 Years — 11 Years
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria for the Extension Cohort: 1\. Participants who have completed the treatment phase of the qualifying parent study (age 2 to \<12 years old). • No contraception methods are required for male participants. Female participants must not be pregnant or breastfeeding and, if the partic...

Countries:United StatesChinaGermanyHungaryJapanMexicoPolandSpainIndiaAustraliaBulgariaCanadaChileFinlandItalyLatviaSlovakiaSouth KoreaTaiwan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06807281primaryCompletionDate: changed
LOWMay 24, 2026NCT06807281studyFirstPostDate: changed