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    Summary
    EudraCT Number:2020-001509-21
    Sponsor's Protocol Code Number:B7981037
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-07
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-001509-21
    A.3Full title of the trial
    A PHASE 2a, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY INVESTIGATING THE SAFETY OF RITLECITINIB (PF 06651600) IN ADULT PARTICIPANTS WITH ALOPECIA AREATA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA
    A.4.1Sponsor's protocol code numberB7981037
    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., 66 Hudson Boulevard East, New York, NY 10001
    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 Centre
    B.5.3 Address:
    B.5.3.1Street Address66 Hudson Boulevard East
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY10001
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 800 7181021
    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.3.1Product nameRitlecitinib
    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 INNRitlecitinib
    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.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.3.1Product nameRitlecitinib
    D.3.2Product code PF-06651600
    D.3.4Pharmaceutical form Capsule
    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 INNRitlecitinib
    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
    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
    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
    Primary Safety:
    To assess I-V interwave latency on brainstem auditory evoked potentials (BAEPs) in adult participants with alopecia areata (AA) treated with PF-06651600.
    E.2.2Secondary objectives of the trial
    Safety:
    -To assess I-V interwave latency on BAEPs in adult participants with AA treated with PF-06651600.
    -To assess axonal dystrophy in intraepidermal nerve endings over time in adult participants with AA treated with PF 06651600
    -To assess intraepidermal nerve fiber density (IENFD) over time in adult participants with AA treated with PF 06651600.
    -To assess wave V amplitude on BAEP over time in adult participants with AA treated with PF-06651600.
    - To assess presence of wave V on BAEP over time in adult participants with AA treated with PF-06651600.
    -To evaluate the safety and tolerability of PF-06651600 in adult participants with AA.
    Efficacy:
    -To evaluate response to PF-06651600 measured by the Severity of Alopecia Tool (SALT) in adult participants with AA.
    -To evaluate the response to PF-06651600 measured by the Patient’s Global Impression of Change (PGI-C) tool in adult participants with AA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Have a clinical diagnosis of AA and ≥25% scalp hair loss (including AT and AU) due to AA.
    2.Have normal hearing and BAEP assessments at screening.
    3.Have a normal neurological examination by a neurologist at screening (unilateral carpal tunnel syndrome or median nerve neuropathy permitted).
    4.Male or female (not pregnant or breastfeeding) subjects between18 to 50 years.
    5.Female (not pregnant or breastfeeding) participants must be either be a WOCBP and using a highly effective contraceptive method or not be of childbearing potential (WOCBP).
    E.4Principal exclusion criteria
    1.Other medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior.
    2.Any current hearing loss or current disease that can affect hearing.
    3.Current or history of clinically significant central or peripheral neurological disease
    4.First degree family history of hereditary neuropathy.
    5.Any history of peripheral neuropathy (PN), including diabetic PN, chemotherapy-induced PN, drug-induced PN, genetic PN, idiopathic PN, etc.
    6.Current or recent history of clinically significant severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine (particularly thyroid disease and parathyroid disease, which can be associated with hair loss), pulmonary, cardiovascular, psychiatric, immunologic (other than AA), rheumatologic, dermatologic or neurologic disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
    7.Any present malignancies or history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
    8.History of any lymphoproliferative disorder.
    9.History of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
    10.History of systemic infection requiring hospitalization, parenteral antimicrobial therapy within 6 months prior to Day 1
    11.Known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
    12.History of HIV or positive serology for human immunodeficiency virus (HIV) at screening.
    13.Considered in imminent need for surgery.
    14.Active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1
    15.Infection with hepatitis B or hepatitis C viruses.
    16.Have evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection.
    17.Abnormal findings on the screening chest radiographs (eg, chest x-ray) including, but not limited to, presence of active TB, infection, cardiomyopathy, or malignancy.

    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in I-V interwave latency on BAEP at a stimulus intensity of 80 decibels (dB) at Month 9.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 9
    E.5.2Secondary end point(s)
    •Change from baseline in I-V interwave latency on BAEP at a stimulus intensity of 80dB at Months 6, 9E, and 15E.
    •Change from baseline in axonal dystrophy in skin punch biopsies at Month 9 and Month 15E.
    •Change from baseline in IENFD in skin punch biopsies at Month 9 and Month 15E.
    •Change from baseline in amplitude of wave V on BAEP at a stimulus intensity of 80dB at Months 6, 9, 9E, and 15E.
    •Absence of wave V on BAEP at stimulus intensities ranging from 80dB to 40dB at Months 6, 9, 9E, and 15E.
    •Incidence of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and adverse events (AEs) leading to discontinuation;
    •Incidence of clinically significant abnormalities in vital signs and ECG;
    •Incidence of clinically significant abnormalities in clinical laboratory values.
    •Change from baseline in overall and AA SALTa score at Month 9 and other time points collected
    •PGI-C score response defined as greatly improved or moderately improved at Month 9 and other time points collected.
    E.5.2.1Timepoint(s) of evaluation of this end point
    80dB at Months 6, 9E, and 15E.
    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 No
    E.6.7Pharmacodynamic No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 trial2
    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 concerned8
    E.8.5The trial involves multiple Member States No
    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
    Australia
    Canada
    United States
    Poland
    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 months7
    E.8.9.1In the Member State concerned days23
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days26
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 72
    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 B7981037 study completion, eligible patients may have the opportunity to receive PF-06651600 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 Decision2020-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-05-07
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