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

NCT04345367

Last updated date
Study Location
Keck School of Medicine of University of Southern California, Dermatology Research Office
Los Angeles, California, 90033, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atopic Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2020)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2, 2021
Estimated Primary Completion Date October 2, 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: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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 CenterPfizer
PRS Account Pfizer
Verification Date November 2020

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