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    Summary
    EudraCT Number:2019-001084-71
    Sponsor's Protocol Code Number:B7981032
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-02-06
    Trial 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2019-001084-71
    A.3Full title of the trial
    A PHASE 3 OPEN LABEL, MULTI CENTER, LONG TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-Term PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-LT)
    A.4.1Sponsor's protocol code numberB7981032
    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. 235 East 42nd Street, New York, New York
    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
    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.3.9.1CAS number Not availabl
    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
    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 long term safety and tolerability of PF-06651600 in adult and adolescent participants with AA in the treatment period over time.
    E.2.2Secondary objectives of the trial
    To evaluate the long term efficacy of PF-6651600 in adult and adolescent participants with AA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for De Novo Participants and Those Originating from B7931005 or B7981015 with >30 Days between the Index Study and Study B7981032
    1.Participants must meet the following AA criteria:
    •Have a clinical diagnosis of AA with no other etiology of hair loss (including, but not limited to traction and scarring alopecia, telogen effluvium). Androgenetic alopecia coexistent with AA is allowed provided that the following criteria are met;
    • >=25% terminal scalp hair loss due to AA (including AT and AU), as measured
    by SALT, at both the screening and Day 1 visits which, in the opinion of the investigator, is appropriate for systemic therapy;
    •Hair loss must be carefully reviewed to verify that >=25% scalp hair loss is due to AA (ie, SALT (AA) score is >=25%). If, in cases of concomitant AA and androgenetic alopecia, it cannot be verified that SALT (AA) score is >=25%, then the participant must be excluded from the study.
    •No evidence of terminal scalp hair regrowth within 6 months of both the screening and Day 1 visits (for de novo participants only);
    •Current episode of terminal scalp hair loss due to AA =<10 years (for de novo participants only);
    •When determining the duration of "current episode of terminal scalp hair loss", the initiation of the current episode should be the last time when the patient had substantial scalp hair (regardless of whether that hair growth occurred spontaneously or was the result of interventional treatment).
    Inclusion Criteria for All Participants Originating from B7931005 or B7981015
    2.Participants enrolling from Study B7931005 must have:
    •Taken the last dose of PF 06700841 (a TYK2/JAK1 inhibitor) in Study B7931005 >12 weeks prior to the Study B7981032 Day 1 visit.
    3.Participants enrolling from Study B7981015 must have:
    •Completed >=34 weeks of study intervention.
    Inclusion Criteria for All Participants
    4.All participants must be >=12 years of age, at the time they or their parent or guardian signs the informed consent. Participants 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 participants 18 years or
    older (or age 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.
    5.Male or Female. For all participants contraceptive use by men or women should be
    consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    a.Male participants: No contraceptive measures required.
    b.Female participants:
    •A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    •Is not a woman of childbearing potential (WOCBP), See Appendix 4.
    •OR
    •Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Appendix 4 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.
    •A WOCBP must have a negative highly sensitive (Appendix 2) pregnancy test (urine or serum as required by local regulations) at the Day 1 visit before the first dose of study intervention.
    •If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
    •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
    6.All participants must be capable of giving signed informed consent/assent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    7.All participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    8.If receiving permitted concomitant medications for any reason other than AA, participants 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 Day1.Participants must be willing to stay on a stable regimen during the duration of the study (see Section 6.5).
    9.All participants 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.
    E.4Principal exclusion criteria
    Exclusion Criteria for Participants Originating from B7931005 or B7981015 with <=30 Days between Studies
    1.During Study B7931005 or B7981015 or in the period between the index study and Study B7981032, presence of events meeting criteria in the Discontinuation section of Appendix 8 (eg, serious infections, laboratory results, ECG results) other than discontinuation criteria for worsening of AA. .
    2.Discontinuation from Study B7931005 or B7981015 for safety related events. Participants discontinued from Study B7931005 or B7981015 due to issues other than safety-related events must be discussed with the sponsor prior to enrollment in Study B7981032.
    Exclusion Criteria for De Novo Participants and Those Originating from B7931005 or B7981015 with >30 Days between the Index Study and Study B7981032
    3.Other scalp disease that may impact AA assessment (eg, scalp psoriasis, dermatitis, etc).
    4.Active systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc).
    5.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) (Section 8.2.9).
    b.For participants 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 participant to participate in the trial.
    c.The presence of any current major psychiatric disorder that is not explicitly permitted in the inclusion/exclusion criteria.
    d.Clinically significant depression as indicated by a Patient Health Questionnaire 8 Items (PHQ 8) total score >=15 (Section 8.2.10).
    NOTE: For any participant who has significant depression or any suicidal behavior, the participant will not be assigned to study intervention and should be referred for appropriate evaluation and treatment.
    6.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.
    •Participants originating from Study B7931005 or B7981015 with occurrences of any of the above either during the index study or between the end of the index study and Study B7981032 can only be enrolled in Study B7981032 with prior approval of the sponsor.
    Exclusion Criteria for All Participants
    7.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 participants who are Pfizer employees, including their family members, directly involved in the conduct of the study.
    8.Participation in studies other than B7931005 or B7981015 involving investigational drug(s) within 8 weeks (12 weeks for JAK inhibitors other than PF 06651600 received in Study B7931005 or B7981015) or within 5 half lives (if known), whichever is longer, prior to study entry and/or during study participation.
    Please see the Protocol for a complete list of exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    •Incidence of treatment emergent adverse events (TEAEs);
    •Incidence of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation;
    •Incidence of clinically significant abnormalities in vital signs;
    •Incidence of clinically significant abnormalities in clinical laboratory values.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ongoing evaluation at intermittent timepoints until Day 720/EOT
    E.5.2Secondary end point(s)
    •Response based on achieving absolute Severity of Alopecia Tool (SALT) score ≤10 at all time points collected, for overall and AA SALT score;
    •Response based on achieving absolute SALT score ≤20 at all time points collected, for overall and AA SALT score;
    •Absolute SALT scores at all time points collected, for overall and AA SALT score;
    •Change from baseline in SALT score at all timepoints collected, for overall and AA SALT score;
    •Response based on achieving at least 50% improvement in SALT (SALT50) from baseline at all time points collected, for overall and AA SALT score;
    •Response based on achieving at least 75%, improvement in SALT (SALT75) from baseline at all time points collected, for overall and AA SALT score;
    •Response based on achieving at least a 2 grade improvement from baseline or a score of 3 in Eyebrow Assessment (EBA) score at all time points collected;
    •Response based on achieving at a least 2 grade improvement from baseline or a score of 3 in Eyelash Assessment (ELA) score at all time points collected.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the Month 24 or Early Termination visit
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    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
    Czech Republic
    Germany
    Hungary
    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 years2
    E.8.9.1In the Member State concerned months11
    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 months11
    E.8.9.2In all countries concerned by the trial days0
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 129
    F.4.2.2In the whole clinical trial 860
    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)
    There is no intervention required by the protocol following the end of the study
    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 Decision2020-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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