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Trial record 2 of 8 for:    abrocitinib | Atopic Dermatitis

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 : July 26, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 27, 2020
First Posted Date  ICMJE April 14, 2020
Last Update Posted Date July 26, 2021
Actual Study Start Date  ICMJE June 11, 2020
Actual Primary Completion Date July 13, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2020)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
  • Change in Peak Pruritus Numerical Rating Scale (PP-NRS) [ Time Frame: Change from Baseline to Week 2 ]
    Response based on achieving at least a 4-point improvement in the severity of PP-NRS 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-75 (≥75% improvement from baseline) at Week 4
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
  • Change in Eczema Area and Severity Index (EASI) [ Time Frame: Change from Baseline to Week 16 ]
    Response based on achieving the EASI-75 (≥75% improvement from baseline) at Week 16
  • 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 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 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-NRS) [ 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-NRS from baseline at all scheduled time points except Week 2
  • Change in Peak Pruritus Numerical Rating Scale (PP-NRS) [ Time Frame: Change from Baseline to Week 30 ]
    Time from baseline to achieve at least a 4-point improvement in the severity of PP-NRS 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
Current Other Pre-specified Outcome Measures
 (submitted: September 21, 2020)
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Abrocitinib 200 mg plus placebo injection
    Abrocitinib 200 mg daily through Week 26, plus placebo injections every other week through Week 24
    Intervention: Drug: Abrocitinib 200 mg
  • 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
    Intervention: Combination Product: Dupilumab 300 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2021)
728
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2020)
600
Actual Study Completion Date  ICMJE July 13, 2021
Actual Primary Completion Date July 13, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bulgaria,   Canada,   Chile,   Finland,   Germany,   Hungary,   Italy,   Korea, Republic of,   Latvia,   Poland,   Slovakia,   Spain,   Taiwan,   United States
Removed Location Countries Belgium,   Czechia
 
Administrative Information
NCT Number  ICMJE NCT04345367
Other Study ID Numbers  ICMJE B7451050
2019-004013-13 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP