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    Summary
    EudraCT Number:2018-001714-14
    Sponsor's Protocol Code Number:B7981015
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-07-01
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2018-001714-14
    A.3Full title of the trial
    A PHASE 2B/3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-06651600 IN ADULT AND ADOLESCENT ALOPECIA AREATA (AA) SUBJECTS WITH 50% OR GREATER SCALP HAIR LOSS
    Randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie fáze 2b/3 ke zjištění účinnosti a bezpečnosti přípravku PF-06651600 podávaného v různých dávkách dospělým a adolescentním subjektům s výpadem vlasů (Alopecia Areata, AA) 50 % nebo vyšším
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY OF PF-06651600 IN ADULT AND ADOLESCENT ALOPECIA AREATA (AA) SUBJECTS WITH 50% OR GREATER SCALP HAIR LOSS
    A.4.1Sponsor's protocol code numberB7981015
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03732807
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code PF-06651600-15, 10mg
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codePF-06651600
    D.3.9.3Other descriptive nameJanus Kinase 3 inhibitor
    D.3.9.4EV Substance CodeSUB174316
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code PF-06651600-15, 50mg
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codePF-06651600
    D.3.9.3Other descriptive nameJanus Kinase 3 inhibitor
    D.3.9.4EV Substance CodeSUB174316
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alopecia areata
    E.1.1.1Medical condition in easily understood language
    Scalp Hair Loss
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10001761
    E.1.2Term Alopecia areata
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of PF-06651600 compared to placebo in adult and adolescent alopecia areata (AA) subjects with 50% or greater scalp hair loss on regrowth of lost hair (as measured by an absolute Severity of Alopecia Tool (SALT) Score ≤20).

    Note: For the European Union (EU) (including the Voluntary Harmonisation Procedure [VHP] countries),a as well as if required by any other regulatory agencies, the primary objective is to evaluate the efficacy of PF- 06651600 compared to placebo in adult and adolescent AA subjects with 50% or greater scalp hair loss on regrowth of lost hair (as measured by an absolute SALT Score ≤10) at Week 24.
    E.2.2Secondary objectives of the trial
    • To characterize the exposure response of PF-6651600 on regrowth of lost hair.
    • To assess the efficacy of PF-06651600 on regrowth of lost hair during the treatment period over time.
    • To evaluate the effect of PF-06651600 on patient-centered outcomes and payer relevant measures to assess treatment benefit from the patient perspective and to demonstrate value.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Banked biospecimens, amendment 2, 30 May 2019
    E.3Principal inclusion criteria
    1.Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative/parent(s)/legal guardian has been informed of all pertinent aspects of the study.
    2.Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    3.Male or female subjects age 12 years and older, inclusive, at time of informed consent/assent. Adolescent subjects below the age of 18 years will only be enrolled into this study if permitted by the sponsor, local competent authority, and institutional review board (IRB)/ethics committee (EC). Otherwise, only subjects 18 years or older (or age specified by applicable reviewer) will be enrolled in those countries, regions, or sites. Within the EU, subjects must be aged 18 through 74 years at the time of informed consent.
    4.Subjects must meet/comply with the following reproductive criteria:
    Females:
    Female subjects are eligible to participate if they are not pregnant or breastfeeding, and at least 1 of the following conditions applies:
    a.Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of <1% per year), as described in Section 4.3, during the intervention period and for at least 28 days after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
    OR
    b.Is not a WOCBP (see definitions below):
    Women in the following categories are not considered WOCBP:
    •Premenarchal.
    •Premenopausal female with 1 of the following:
    •Documented hysterectomy;
    •Documented bilateral salpingectomy;
    •Documented bilateral oophorectomy.
    For individuals with permanent infertility due to an alternate medical cause other than the above, (eg, Müllerian agenesis, androgen insensitivity), investigator discretion should be applied to determining study entry.
    Note: Documentation for any of the above categories can come from the site personnel’s review of the participant’s medical records, medical examination, or medical history interview. The method of documentation should be recorded in the participant’s medical record for the study.
    •Postmenopausal female:
    A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. In addition, a high follicle stimulating hormone (FSH) level in the postmenopausal range must be used to confirm a postmenopausal state in women under 60 years old and not using hormonal contraception or hormone replacement therapy (HRT). Females on HRT and whose menopausal status is in doubt will be required to use one of the nonestrogen hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.
    The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Documentation of this review should be included in the participant’s medical record for the study.
    Males:
    Outside of VHP countries in the EU, no contraceptive methods are required for male subjects in this study.
    Within VHP countries in the EU, male subjects are eligible to participate if they agree to the following requirements during the intervention period and for at least 90 days after the last dose of study intervention:
    •Refrain from donating sperm AND
    •Use one acceptable method of contraception as described in Section 4.3.
    5.Must meet the following AA criteria:
    a.Have a clinical diagnosis of AA with no other etiology of hair loss (eg, telogen effluvium, androgenetic alopecia, etc.).
    b.50% hair loss of the scalp, including alopecia totalis (AT) and alopecia universalis (AU), without evidence of terminal hair regrowth within 6 months at both the screening and baseline visits.
    •AT is defined as complete (100%) scalp hair loss.
    •AU is defined as complete (100%) scalp, facial, and body hair loss.
    •Percentage of hair loss on the scalp will be measured by SALT (Appendix 5).
    •Photographs taken at Screening must be submitted to the Sponsor or designee for verification of SALT score ≥50 and hair loss due to AA. Subjects must not be randomized until verification has been confirmed.
    c.Current episode of hair loss ≤10 years.
    6.If receiving permitted concomitant medications for any reason other than AA, subjects should be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half lives (whichever is longer) prior to Day 1. Subject must be willing to stay on a stable regimen during the duration of the study (see Section 5.8 of the protocol).
    Please see the Protocol for a complete list of inclusion criteria.
    E.4Principal exclusion criteria
    1. 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.
    2. Participation in other studies involving investigational drug(s) within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to study entry and/or during study participation.
    3. Other types of alopecia (including, but not limited to traction and scarring alopecia, telogen effluvium). Subjects with known androgenetic alopecia will be excluded.
    4. Other scalp disease that may impact AA assessment (eg, scalp psoriasis, dermatitis, etc).
    5. Active systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc).
    6. Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria:
    a. Suicidal ideation associated with actual intent and a method or plan in the past year: “Yes” answers on items 4 or 5 of the Columbia Suicide Severity Rating Scale (C SSRS) (Appendix 6).
    b. For subjects who had previous history of suicidal behaviors in the past >1 year to <5 years: “Yes” answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C SSRS or any lifetime history of serious or recurrent suicidal behavior, a risk assessment must be performed, and documented, by a qualified mental health professional to assess whether it is safe for the subject to participate in the trial.
    c. Clinically significant depression as indicated by the Patient Health Questionnaire - 8 Items (PHQ 8) (Appendix 13) total score ≥15.
    d. The presence of any current major psychiatric disorder that is not explicitly permitted in the inclusion/exclusion criteria.
    NOTE: For any subject who has significant depression or any suicidal behavior, the subject will not be randomized and should be referred for appropriate evaluation and treatment.
    7.Have hearing loss with progression over the previous 5 years, or sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere’s disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating or progressive.
    Please see the Protocol for a complete list of exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    • Response based on an absolute SALT Score ≤20 at Week 24.

    Note: For the EU (including the VHP countries), as well as if required by any other regulatory agencies, response based on an
    absolute SALT Score =10 at Week 24 will be analyzed as the primary endpoint in a separate analysis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    • Response based on an absolute SALT Score ≤20 at Week 24 will be used to characterize the exposure response.
    • Response based on a SALT score of ≤20 at Weeks 4, 8, 12, 18, 28, 34, 40, and 48.
    • Response based on a SALT score of ≤10 at
    Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48.
    • Response based on a 75% improvement in SALT score from baseline (SALT75) at Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48.
    • Change from baseline in SALT scores at Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48.
    • Response based on at least a 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score at Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48.
    • Response based on at least a 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score at Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48.
    • Patient's Global Impression of Change (PGI-C) response defined as a score of "moderately improved or greatly "improved" at Weeks 4, 8, 12,18, 24, 28, 34, 40, and 48.
    • Change from baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) scales at Weeks 4, 8, 12, 18, 24, 34, 40, and 48.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints for each secondary endpoints are defined within the endpoint
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Dose-Ranging
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial7
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Canada
    Chile
    China
    Colombia
    Czechia
    Germany
    Japan
    Korea, Republic of
    Mexico
    Poland
    Russian Federation
    Spain
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 99
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 99
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 545
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 87
    F.4.2.2In the whole clinical trial 660
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After B7981015 study completion, eligible patients may have the opportunity to receive PF-06651600 for an additional 2 years in an open-label long term extension study. Beyond that, patients will not have access to PF-06651600 as the efficacy and safety of the investigational product will not be established until marketing approval is granted. After the study ends, patients should be treated by their physicians with appropriate standard of care management and medications when required.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-24
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