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Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis (JADE EXTEND)

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: NCT03422822
Recruitment Status : Enrolling by invitation
First Posted : February 6, 2018
Last Update Posted : September 15, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 20, 2017
First Posted Date  ICMJE February 6, 2018
Last Update Posted Date September 15, 2020
Actual Study Start Date  ICMJE March 8, 2018
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2020)
  • Treatment emergent adverse events [ Time Frame: Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years ]
    The incidence of treatment emergent adverse events
  • Serious adverse events and adverse events leading to discontinuation [ Time Frame: Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years ]
    The incidence of serious adverse events and adverse events leading to discontinuation
  • Change from baseline in clinical laboratory values [ Time Frame: Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years ]
    Change from baseline in clinical laboratory values
  • Change from baseline in electrocardiogram (ECG) measurements [ Time Frame: Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years ]
    Change from baseline in electrocardiogram (ECG) measurements
  • Change from baseline in vital signs [ Time Frame: Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years ]
    Change from baseline in vital signs
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2018)
  • Treatment emergent adverse events [ Time Frame: Up to 96 weeks ]
    The incidence of treatment emergent adverse events
  • Serious adverse events and adverse events leading to discontinuation [ Time Frame: Up to 96 weeks ]
    The incidence of serious adverse events and adverse events leading to discontinuation
  • Change from baseline in clinical laboratory values [ Time Frame: Up to 96 weeks ]
    Change from baseline in clinical laboratory values
  • Change from baseline in electrocardiogram (ECG) measurements [ Time Frame: Up to 96 weeks ]
    Change from baseline in electrocardiogram (ECG) measurements
  • Change from baseline in vital signs [ Time Frame: Up to 96 weeks ]
    Change from baseline in vital signs
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2020)
  • Investigator's Global Assessment (IGA) [ Time Frame: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]
    Response based on the 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
  • Eczema Area and Severity Index (EASI) [ Time Frame: Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years ]
    Response based on greater than or equal to 50%, 75% and 90% improvement from baseline in the EASI total score (EASI50, EASI75, and EASI90) at all scheduled time points
  • Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]
    Response based on an improvement greater than or equal to 3 points and greater than or equal to 4 points from baseline in the pruritus NRS at all scheduled time points
  • Patient Global Assessment (PtGA) [ Time Frame: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]
    Change from baseline of PtGA at all scheduled time points
  • Body Surface Area (BSA) affected [ Time Frame: Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years ]
    Change from baseline in the percentage BSA affected at all scheduled time points
  • Dermatology Life Quality Index (DLQI) or Children's DLQI (CDLQI) [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]
    Change from baseline in DLQI or CDLQI at all scheduled time points
  • Patient Oriented Eczema Measure (POEM) [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]
    Change from baseline in POEM at all scheduled time points
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96 ]
    Change from baseline in HADS at all scheduled time points
  • EuroQol Quality of Life 5 Dimension 5 Level Scale (EQ-5D-5L) or EuroQol Quality of Life 5 Dimension Youth Scale (EQ-5D-Y) [ Time Frame: Baseline, Week 24, Week 48, Week 60, Week 72, Week 92 ]
    Change from baseline of EQ-5D-5L or EQ-5D-Y at all scheduled time points
  • Steroid-Free Days [ Time Frame: Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years ]
    Number of steroid-free days will be assessed throughout the duration of the study.
  • Serum Hs-CRP Levels [ Time Frame: Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years ]
    Serum Hs-CRP levels at all scheduled time points
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2018)
  • Investigator's Global Assessment (IGA) [ Time Frame: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96 ]
    Response based on the 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
  • Eczema Area and Severity Index (EASI) [ Time Frame: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96 ]
    Response based on greater than or equal to 50%, 75% and 90% improvement from baseline in the EASI total score (EASI50, EASI75, and EASI90) at all scheduled time points
  • Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96 ]
    Response based on an improvement greater than or equal to 3 points and greater than or equal to 4 points from baseline in the pruritus NRS at all scheduled time points
  • Patient Global Assessment (PtGA) [ Time Frame: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96 ]
    Change from baseline of PtGA at all scheduled time points
  • Body Surface Area (BSA) affected [ Time Frame: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96 ]
    Change from baseline in the percentage BSA affected at all scheduled time points
  • Dermatology Life Quality Index (DLQI) or Children's DLQI (CDLQI) [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96 ]
    Change from baseline in DLQI or CDLQI at all scheduled time points
  • Patient Oriented Eczema Measure (POEM) [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96 ]
    Change from baseline in POEM at all scheduled time points
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96 ]
    Change from baseline in HADS at all scheduled time points
  • EuroQol Quality of Life 5 Dimension 5 Level Scale (EQ-5D-5L) or EuroQol Quality of Life 5 Dimension Youth Scale (EQ-5D-Y) [ Time Frame: Baseline, Week 24, Week 48, Week 60, Week 64, Week 72, Week 92, Week 96 ]
    Change from baseline of EQ-5D-5L or EQ-5D-Y at all scheduled time points
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
Official Title  ICMJE A PHASE 3 MULTI-CENTER, LONG-TERM EXTENSION STUDY INVESTIGATING THE EFFICACY AND SAFETY OF ABROCITINIB, WITH OR WITHOUT TOPICAL MEDICATIONS, ADMINISTERED TO SUBJECTS AGED 12 YEARS AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS
Brief Summary B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying Phase 3 study. The efficacy and safety of two dosage strengths of Abrocitinib, 100 mg and 200 mg taken orally once daily, will be evaluated over variable lengths of study participation. The study consists of a 92 week initial treatment period followed by a variable length secondary treatment period during which subjects will receive treatment with open-label abrocitinib until availability of commercial product in their country, or until the sponsor terminates the study in that country
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 Dermatitis, Atopic
Intervention  ICMJE
  • Drug: Abrocitinib 100 mg
    In the initial treatment period, Abrocitinib 100 mg, administered as two tablets to be taken orally once daily.
  • Drug: Abrocitinib 200 mg
    In the initial treatment period, Abrocitinib 200 mg, administered as two tablets to be taken orally once daily.
  • Drug: Placebo
    For subjects whose dose was changed from 100 mg Abrocitinib to placebo, one tablet will be administered to be taken orally once daily for the remainder of the study.
  • Drug: Abrocitinib 100 mg
    For subjects whose dose was changed from 200 mg Abrocitinib to 100 mg PF-04965842, one tablet will be administered to be taken orally once daily for the remainder of the study.
  • Drug: Abrocitinib 100 mg
    In the secondary treatment period, Abrocitinib 100 mg, administered as one tablet to be taken orally once daily.
  • Drug: Abrocitinib 200 mg
    In the secondary treatment period, Abrocitinib 200 mg, administered as two tablets to be taken orally once daily.
Study Arms  ICMJE
  • Experimental: Abrocitinib 100 mg
    Abrocitinib 100 mg QD PO
    Interventions:
    • Drug: Abrocitinib 100 mg
    • Drug: Placebo
    • Drug: Abrocitinib 100 mg
  • Experimental: Abrocitinib 200 mg
    Abrocitinib 200 mg QD PO
    Interventions:
    • Drug: Abrocitinib 200 mg
    • Drug: Abrocitinib 100 mg
    • Drug: Abrocitinib 200 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 Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: October 17, 2019)
3000
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2018)
1260
Estimated Study Completion Date  ICMJE December 1, 2023
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Evidence of a personally signed and dated informed consent document indicating that the subject or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study.
  2. Male or female subjects of 12 years of age or older, at the time of informed consent and meets inclusion criterion for minimum body weight (if applicable) from qualifying Parent study. Adolescent subjects below the age of 18 years old (or country-specific age of majority) will only be enrolled in this study if instructed by the sponsor and approved by the country or regulatory/health authority. If these approvals have not been granted, only subjects aged 18 years (or country-specific age of majority) and older will be enrolled.
  3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
  4. Must have completed the full treatment period of a qualifying Parent study OR must have completed the full rescue treatment period of a qualifying Parent study (if applicable) OR must have completed the full open-label run-in period in B7451014 and did not meet the protocol-specified response criteria at Week 12.
  5. Female subjects who are of childbearing potential (which includes all female subjects aged 12 years and older, regardless of whether they have experienced menarche) must ot be intending to become pregnant, currently pregnant, or lactating. The following onditions apply:

    1. Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to allocation to treatment.
    2. Female subjects of childbearing potential must agree to use a highly effective method of contraception (as per Section 4.4.1) for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.

      For Czech Republic only, 5 b. is revised and 5 c. is added to require:

      Female subjects of childbearing potential 15 years of age who are at risk of pregnancy must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.

    3. Female subjects less than 15 years of age must not be sexually active, and abstinence per the below definition should be confirmed prior to enrollment. NOTE: Sexual abstinence, defined as completely and persistently refraining from all heterosexual intercourse (including during the entire period of risk associated with the study treatments) may obviate the need for contraception ONLY if this is the preferred and usual lifestyle of the subject.
  6. Female subjects of non-childbearing potential must meet at least 1 of the following criteria:

    1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    2. Have medically confirmed ovarian failure; or
    3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
  7. Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.
  8. Must agree to avoid use of prohibited medications throughout the duration of the study. Exclusion Criteria

1. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

2. Currently have active forms of other inflammatory skin diseases, ie, not AD or have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of Day -1 that would interfere with evaluation of atopic dermatitis or response to treatment.

3. Discontinued from treatment (or rescue treatment period/open-label run-in period, if applicable) early in a qualifying Parent study OR triggered a discontinuation criterion at any point during the qualifying Parent study which in the opinion of the investigator, or sponsor, is an ongoing safety concern.

4. Ongoing adverse event in the qualifying Parent study which in the opinion of the investigator, or sponsor, is an ongoing safety concern. 5. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, 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 Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Czechia,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Mexico,   Netherlands,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Korea, Democratic People's Republic of
 
Administrative Information
NCT Number  ICMJE NCT03422822
Other Study ID Numbers  ICMJE B7451015
2017-004851-22 ( EudraCT Number )
JADE EXTEND B745105 ( Other Identifier: Alias Study Number )
JADE EXTEND ( Other Identifier: Alias Study 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: No
IPD Sharing Statement  ICMJE
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
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 September 2020

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