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Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

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ClinicalTrials.gov Identifier: NCT04345367
Recruitment Status : Completed
First Posted : April 14, 2020
Last Update Posted : March 22, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
This is a randomized, double-blind, double-dummy, active-controlled, multi-center study to assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally QD compared with dupilumab 300 mg administered by subcutaneous injection every other week (as per label guidelines) in adult participants on background topical therapy, with moderate to severe AD. The treatment duration is 26 weeks. A total of approximately 600 participants will be enrolled from approximately 220 sites globally. Approximately 600 participants will be randomly assigned to study intervention. There are primary efficacy assessments at Week 2 and Week 4, and a key secondary efficacy assessment at Week 16. Efficacy and safety endpoints will be assessed throughout the entire study. Exploratory endpoints related to hand eczema efficacy will be assessed throughout the study.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Abrocitinib 200 mg Combination Product: Dupilumab 300 mg Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Dupilumab

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. Medicated topical background therapy-free days [ Time Frame: Baseline to Week 30 ]
    Medicated topical background therapy-free days


Other Outcome Measures:
  1. 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.


  2. 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.


  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Pfizer:
atopic dermatitis
atopic eczema
eczema
JAK
janus kinase
Additional relevant MeSH terms:
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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