Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04345367 |
Recruitment Status :
Completed
First Posted : April 14, 2020
Last Update Posted : March 22, 2022
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atopic Dermatitis | Drug: Abrocitinib 200 mg Combination Product: Dupilumab 300 mg | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 728 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A PHASE 3B RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED MULTI-CENTER STUDY ASSESSING THE EFFICACY AND SAFETY OF ABROCITINIB COMPARED WITH DUPILUMAB IN ADULT PARTICIPANTS ON BACKGROUND TOPICAL THERAPY WITH MODERATE TO SEVERE ATOPIC DERMATITIS |
Actual Study Start Date : | June 11, 2020 |
Actual Primary Completion Date : | July 13, 2021 |
Actual Study Completion Date : | July 13, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Abrocitinib 200 mg plus placebo injection
Abrocitinib 200 mg daily through Week 26, plus placebo injections every other week through Week 24
|
Drug: Abrocitinib 200 mg
Abrocitinib 200 mg administered as two 100 mg tablets to be taken orally once daily for 26 weeks. Placebo injections will be administered every other week for 24 weeks. |
Active Comparator: Dupilumab 300 mg plus placebo tablets
Dupilumab 300 mg every other week (2 injections on Day 1) through Week 24, plus placebo tablets daily through Week 26
|
Combination Product: Dupilumab 300 mg
Dupilumab 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. |
- Change in Peak Pruritus Numerical Rating Scale (PP-NRS4) [ Time Frame: Change from Baseline to Week 2 ]Response based on achieving at least a 4-point improvement in the severity of PP-NRS4 from baseline at Week 2
- Change in Eczema Area and Severity Index (EASI) [ Time Frame: Change from Baseline to Week 4 ]Response based on achieving the EASI-90 (≥90% improvement from baseline) at Week 4
- Change in Eczema Area and Severity Index (EASI) [ Time Frame: Change from Baseline to Week 16 ]Response based on achieving the EASI-90 (≥90% improvement from baseline) at Week 16
- Change in Eczema Area and Severity Index (EASI) [ Time Frame: Change from Baseline to Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26 ]Response based on achieving a 90% improvement in the EASI total score (EASI-90) at all scheduled time points up to Week 26
- Change in Eczema Area and Severity Index (EASI) [ Time Frame: Change from Baseline to Week 2, Week 8, Week 12, Week 20, Week 26 ]Response based on achieving a ≥75% improvement in the EASI total score (EASI-75) at all other scheduled time points up to Week 26
- Change in Investigator's Global Assessment (IGA) [ Time Frame: Change from Baseline to Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26 ]Response based on Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at all scheduled time points up to Week 26
- Change in Peak Pruritus Numerical Rating Scale (PP-NRS4) [ Time Frame: Change from Baseline to Week 4, Week 8, Week 16, Week 20, Week 26, Week 30 ]Response based on achieving at least a 4-point improvement in the severity of PP-NRS4 from baseline at all scheduled time points except Week 2
- Change in Peak Pruritus Numerical Rating Scale (PP-NRS4) [ Time Frame: Change from Baseline to Week 30 ]Time from baseline to achieve at least a 4-point improvement in the severity of PP-NRS4 scale
- Change in Body Surface Area (BSA) [ Time Frame: Change from Baseline to Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 30 ]Percent Change from Baseline in the % Body Surface Area (BSA) affected at all scheduled time points
- Change in Scoring Atopic Dermatitis (SCORAD) [ Time Frame: Change from Baseline to Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 30 ]Percent Change from Baseline in the SCORing Atopic Dermatitis (SCORAD) at all scheduled time points
- Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Change from Baseline to Week 12, Week 16, Week 26 ]Change from baseline in the HADS at all scheduled time points
- Change in Dermatology Life Quality Index (DLQI) [ Time Frame: Change from Baseline to Week 2, Week 12, Week 16, Week 20, Week 26, Week 30 ]Change from baseline in DLQI at all scheduled time points
- Change in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) [ Time Frame: Change from Baseline to Week 12, Week 16, Week 26, Week 30 ]Change from baseline in EQ-5D-5L at all scheduled time points
- Change in Patient-Oriented Eczema Measure (POEM) [ Time Frame: Change from Baseline to Week 12, Week 16, Week 26 ]Change from baseline in POEM at all scheduled time points
- Change in Medical Outcomes Study - Sleep Scale (MOS Sleep Scale) [ Time Frame: Change from Baseline to Week 12, Week 16, Week 26 ]Change from baseline in MOS Sleep Scale at all scheduled time points
- Change in Skin Pain Numerical Rating Scale (NRS) [ Time Frame: Change from Baseline to Week 2, Week 12, Week 16, Week 20, Week 26 ]Change from baseline in Skin Pain NRS at all scheduled time points
- Medicated topical background therapy-free days [ Time Frame: Baseline to Week 30 ]Medicated topical background therapy-free days
- Incidence of treatment-emergent AEs [ Time Frame: Screening through Week 30 (entire study) ]
Incidence of treatment emergent AEs. An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs are classified according to the severity in 3 categories a) mild (AEs does not interfere with participant's usual function); b) moderate (AEs interferes to some extent with participant's usual function) and c) severe (AEs interferes significantly with participant's usual function).
AE's includes local tolerability, discontinuations and clinically significant changes in vital signs and clinical laboratory parameters. The investigator is to record all directly observed AE's and all AE's spontaneously reported by the subject (or subject's legal guardian). In addition, each study subject (or subject's legal guardian) will be questioned about the occurrence of AE's in a non-leading manner.
- Incidence of serious adverse events (SAE)s and AEs leading to discontinuation [ Time Frame: Screening through Week 30 (entire study) ]
Incidence of SAEs, eg. an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Counts of participants who had adverse events leading to discontinuation.
- Incidence of clinical abnormalities and change from baseline in clinical laboratory values, electrocardiogram (ECG) measurements, and vital signs [ Time Frame: Screening through Week 30 (entire study) ]Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). A 12-lead ECG was obtained after the participant had rested quietly for at least 10 minutes. Vital signs (pulse, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance was determined at the investigator's discretion.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 years of age or older
- Diagnosis of chronic atopic dermatitis (AD) for at least 6 months
- Moderate to severe AD (BSA at least 10%, IGA at least 3, EASI at least 16, and PP-NRS severity score at least 4)
- Recent history of inadequate response to treatment with medicated topical therapy for AD, or who have required systemic therapies for control of their disease
Exclusion Criteria:
- Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation
- Have increased risk of developing venous thromboembolism
- Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
- Prior treatment with systemic JAK inhibitors or IL-4 or IL-13 antagonists including dupilumab, lebrikizumab or tralokinumab
- Other active non-AD inflammatory skin diseases or conditions affecting skin
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
- Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345367

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT04345367 |
Other Study ID Numbers: |
B7451050 2019-004013-13 ( EudraCT Number ) |
First Posted: | April 14, 2020 Key Record Dates |
Last Update Posted: | March 22, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. |
URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
atopic dermatitis atopic eczema eczema JAK janus kinase |
Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Abrocitinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |