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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)

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ClinicalTrials.gov Identifier: NCT03422822
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
B7451015 is a Phase 3 study to evaluate PF-04965842 with or without Topical Medications in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis and have completed a qualifying Phase 3 study. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated over approximately two years of study participation. Patients who meet safety step-down criteria will have their dose reduced once, from 200 mg QD to 100 mg QD, or from 100 mg QD to placebo.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: PF-04965842 100 mg Drug: PF-04965842 200 mg Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : September 12, 2022
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: PF-04965842 100 mg Drug: PF-04965842 100 mg
PF-04965842 100 mg, administered as two tablets to be taken orally once daily for up to 92 weeks.

Drug: Placebo
For subjects whose dose was changed from 100 mg PF-04965842 to placebo, one tablet will be administered to be taken orally once daily for the remainder of the study.

Experimental: PF-04965842 200 mg Drug: PF-04965842 200 mg
PF-04965842 200 mg, administered as two tablets to be taken orally once daily for up to 92 weeks

Drug: PF-04965842 100 mg
For subjects whose dose was changed from 200 mg PF-04965842 to 100 mg PF-04965842, one tablet will be administered to be taken orally once daily for the remainder of the study.




Primary Outcome Measures :
  1. Treatment emergent adverse events [ Time Frame: Up to 96 weeks ]
    The incidence of treatment emergent adverse events

  2. 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

  3. Change from baseline in clinical laboratory values [ Time Frame: Up to 96 weeks ]
    Change from baseline in clinical laboratory values

  4. Change from baseline in electrocardiogram (ECG) measurements [ Time Frame: Up to 96 weeks ]
    Change from baseline in electrocardiogram (ECG) measurements

  5. Change from baseline in vital signs [ Time Frame: Up to 96 weeks ]
    Change from baseline in vital signs


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 body weight greater than or equal to 40 kg. Adolescent subjects below the age of 18 years old 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 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 Phase 3 study OR must have completed the full rescue treatment period of a qualifying Phase 3 study (if applicable).

    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 not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:

    1. Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization.
    2. Female subjects of childbearing potential 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.

      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 atopic dermatitis.
      3. Have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of Day 0 that would interfere with evaluation of atopic dermatitis or response to treatment.
      4. Discontinued from treatment (or rescue treatment period, if applicable) early in a qualifying Phase 3 study OR triggered discontinuation criteria at any point during the qualifying Phase 3 study OR meets exclusion criteria of the qualifying Phase 3 study.
      5. Ongoing adverse event in the qualifying Phase 3 study which in the opinion of the investigator, or sponsor, is an ongoing safety concern OR the subject is currently triggering safety monitoring criteria in the qualifying Phase 3 study.
      6. 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.

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): NCT03422822


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03422822     History of Changes
Other Study ID Numbers: B7451015
2017‐004851‐22 ( EudraCT Number )
JADE EXTEND B745105 ( Other Identifier: Alias Study Number )
JADE EXTEND ( Other Identifier: Alias Study Number )
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
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: No
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