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    Summary
    EudraCT Number:2020-003610-12
    Sponsor's Protocol Code Number:B7451064
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-12-08
    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 ConcernedGreece - EOF
    A.2EudraCT number2020-003610-12
    A.3Full title of the trial
    ABROCITINIB EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADOLESCENTS AND ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This expanded access protocol will provide access to abrocitinib until it becomes commercially available to patients
    A.4.1Sponsor's protocol code numberB7451064
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04564755
    A.5.4Other Identifiers
    Name:US INDNumber:123554
    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 Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street,
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 800 718 1021
    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 nameAbrocitinib
    D.3.2Product code PF-04965842
    D.3.4Pharmaceutical form Film-coated 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 INNPF-04965842
    D.3.9.1CAS number PF-04965842
    D.3.9.3Other descriptive nameabrocitinib
    D.3.9.4EV Substance CodeSUB177174
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Moderate to severe atopic dermatitis (AD)
    E.1.1.1Medical condition in easily understood language
    Atopic dermatitis is also known as atopic eczema. It is a type of inflammation of the skin that results in itchy, red, swollen, and cracked skin.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To provide access to abrocitinib to adolescent and adult patients with or without background topical therapy who have inadequate treatment options due to inadequate response or intolerance to available approved medicated topical and systemic therapies and need abrocitinib as a possible treatment regimen for moderate to severe AD.
    E.2.2Secondary objectives of the trial
    To gain additional safety and tolerability data for abrocitinib 100 mg and 200 mg once daily (QD) with or without background topical therapy in adolescent and adult participants with moderate to severe AD in a ‘real world’ clinical setting.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    Age:
    1. Participants 12 years of age or older at the time of signing the informed consent. Adolescent participants below the age of 18 years(or country -specific age of majority) will only be enrolled if approved by the country regulatory/health authority. If these approvals have not been granted, only participants 18 years of age (or country-specific age of majority) or older at the time of signing of informed consent may be enrolled.
    2. Participants who meet all of the following atopic dermatitis criteria:
    - Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 6months prior to Day 1 and has confirmed atopic dermatitis at the Screening and Baseline visits according to Hanifin and Rajka criteria for AD.10 Refer to protocol. -Inadequate treatment options for moderate to severe AD due to history of inadequate response or intolerance to treatment with available approved medicated topical and systemic therapies for the treatment of AD, underlying conditions that preclude use of available approved medicated topical and systemic therapies for the treatment of AD, or lack of availability or access to approved medicated topical and systemic therapies for the treatment of AD.
    NOTE: Medicated topical therapy is defined as a topical product that contains an active pharmaceutical ingredient indicated for the treatment of AD (irrespective of whether it is an over the counter [OTC] or prescribed product).
    - Moderate to severe AD as indicated by meeting at least 1of the following on the day of the baseline visit: IGA ≥3; EASI ≥16.
    3. Participants who are ineligible for participation in any ongoing clinical trial of abrocitinib, including lack of access due to geographical limitations.
    4. Participants and, as applicable, parents/legal guardians of age of minority participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
    Sex:
    5. Male or Female
    Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Refer to protocol.
    a. Male participants: No contraceptive measures are 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) (Refer to the definition in the Contraceptive Guidance appendix).
    OR
    - Is a WOCBP.A WOCBP who is sexually active must use a contraceptive method that is highly effective, with a failure rate of <1%, as described in Contraceptive Guidanceappendixduring theintervention period and for at least 28 days after the last dose of abrocitinib. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of abrocitinib.
    - A WOCBP must have a negative highly sensitive(refer to the Clinical Laboratory Tests appendix)serum pregnancy test at the Screening visit. A urine pregnancy test with a sensitivity of at least 25 mIU/mL, will be performed before the first dose of abrocitinib and at every site visit including the EOT and Follow-up/EOS visits to confirm the participant has not become pregnant. 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.
    Please refer to section 5.1 of the protocol for a complete list of inclusion criteria
    E.4Principal exclusion criteria
    Medical Conditions:
    1. Other medical or psychiatric condition including recent(within the past year)or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
    2. The participant must have a risk assessment done by a qualified mental health professional (MHP) to assess whether it is safe to participate in the trial if the participant’s responses on any of the screening instruments or other information from the screening period indicate:
    - Suicidal ideation associated with actual intent and a method or plan in the past year for adults or at any time in their lifetime for adolescents ages ≥12 and <18years: “Yes” answers on items 4 or 5 of the Columbia Suicide Severity Rating Scale (C-SSRS).
    - Previous history of suicidal behaviors in the past 5 years for adults or at any time in their lifetime for adolescents ages ≥12 and <18 years: “Yes” answer (in the past 5 years for adults or at any time in their lifetime for adolescents) to any of the suicidal behavior items of the C-SSRS.
    - Any lifetime history of serious or recurrent suicidal behavior (non-suicidal self-injurious behavior is not a trigger for a risk assessment unless in the investigator’s judgement it is indicated).
    - Clinically significant depression: Patient Health Questionnaire 8 items (PHQ-8) when the total score is≥15 for adults or≥10for adolescents ages ≥12 and <18years.
    - The presence of any current major psychiatric disorder that is not explicitly permitted in the inclusion/exclusion criteria.
    - In the investigator’s judgment a risk assessment or exclusion is required.
    3. Have increased risk of developing venous thromboembolism, eg, deep vein thrombosis or pulmonary embolism:
    - History of venous thromboembolism, or
    - First-degree relative with unprovoked venous thromboembolism (ie, without known underlying cause such as trauma, surgery, immobilization, prolonged travel, pregnancy, hormone use, or plaster cast), that would suggest participant is at increased risk of inherited coagulation disorder (eg,Factor V Leiden).
    4. A current or past medical history of conditions associated with thrombocytopenia, coagulopathy, or platelet dysfunction.
    5. Receiving anti-coagulants or medications known to cause thrombocytopenia (unless considered safe to stop and washout for the duration of the study).
    6. Have a history of any lymphoproliferative disorder such as Epstein Barr virus (EBV), related lymphoproliferative disorder, history of lymphoma, leukemia, or signs or symptoms suggestive of current lymphatic or lymphoid disease.
    7. Infection history:
    - Have a history of systemic infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator within 6months prior to Day1;
    - Have active chronic or acute skin infection requiring treatment with systemic antimicrobials within 2weeks prior to Day1, or superficial skin infections within 1week prior to Day1;
    - A participant known to be infected with human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
    • Screening for Hepatitis B will include testing for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb). Participants who are HBsAg negative and HBcAb positive will have testing for HBsAb. Participants who are HBsAg negative, HBcAb positive, and HBsAb positive at Screening will have testing for hepatitis B Virus (HBV) deoxyribonucleic acid (DNA). Participants who have HBV DNA above the lower limit of quantification (LLQ) are excluded. Participants who have HBV DNA negative or below LLQ may be assigned to abrocitinib on Study Day 1 but will have HBV DNA testing repeated at the Q12 week visits, at the End of Treatment (EOT) visit, and at the Follow-up/End of Study visit
    8. Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
    9. Have a known immunodeficiency disorder.
    10. Have a history of alcohol or substance abuse within 6 months prior to Day 1 that in the opinion of the investigator will preclude participation in the study.
    Please refer to section 5.2 of the protocol for a complete list of exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    Not Applicable
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not Applicable
    E.5.2Secondary end point(s)
    Secondary Endpoints :
    All participants who receive abrocitinib (safety population) will be included in the safety analyses. All safety data will be summarized descriptively. Safety endpoints for the study include:
    •Treatment emergent AEs and SAEs;
    •Withdrawals from active treatment due to AEs and SAEs;
    •Serious infections, defined as any infection (viral, bacterial, and fungal) requiring hospitalization or parenteral antimicrobials.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    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) 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 EEA23
    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
    Taiwan
    United States
    Austria
    Netherlands
    Spain
    Switzerland
    Greece
    Belgium
    Russian Federation
    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
    The study will terminate for all participants enrolled in a country when abrocitinib becomes commercially available in that country or until the sponsor terminates the study in that country. The end of the study is defined as the date of the last scheduled procedure as shown in the Summary of Activities for the last participant in the trial globally.
    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 months3
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    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: 55
    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: 55
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 370
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 460
    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)
    No difference from the expected normal treatment of that condition.
    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 Decision2022-01-20
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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