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    Summary
    EudraCT Number:2021-002897-19
    Sponsor's Protocol Code Number:C1131003
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-12-30
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2021-002897-19
    A.3Full title of the trial
    AN INTERVENTIONAL PHASE 2, OPEN-LABEL, ONE-ARM, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06835375 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE PRIMARY IMMUNE THROMBOCYTOPENIA
    INTERVENČNÍ, OTEVŘENÁ, JEDNORAMENNÁ, MULTICENTRICKÁ STUDIE FÁZE 2 HODNOTÍCÍ BEZPEČNOST A ÚČINNOST PŘÍPRAVKU PF-06835375 U DOSPĚLÝCH ÚČASTNÍKŮ SE STŘEDNĚ ZÁVAŽNOU AŽ ZÁVAŽNOU PRIMÁRNÍ IMUNITNÍ TROMBOCYTOPENIÍ
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Open-Label Safety and Efficacy Study of PF-06835375 in adult participants with Immune thrombocytopenia, a disorder in which there is a reduced amount of platelets in the blood stream which are important for blood to clot normally
    A.3.2Name or abbreviated title of the trial where available
    A Phase 2 Open-Label Safety and Efficacy Study of PF-06835375
    A.4.1Sponsor's protocol code numberC1131003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05070845
    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 code10017
    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 namePF-06835375
    D.3.2Product code PF-06835375
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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-06835375
    D.3.9.3Other descriptive namePF-06835375
    D.3.9.4EV Substance CodeSUB235359
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typePF-06835375 is a selective, humanized, afucosyl Ig G1 antibody against CXCR5.
    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
    Primary immune thrombocytopenia
    E.1.1.1Medical condition in easily understood language
    Immune thrombocytopenia is a disorder characterized by a blood abnormality called thrombocytopenia, which is a shortage of blood cells called platelets that are needed for normal blood clotting.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10083843
    E.1.2Term Primary immune thrombocytopenia
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate absolute value of platelet count of treated participants at Week 12
    E.2.2Secondary objectives of the trial
    To evaluate proportion of participants with modified overall response (mOR) at Week 12
    To evaluate proportion of participants with complete response (CR) at Week 12
    To evaluate safety and tolerability of PF-06835375
    To evaluate effect of PF-06835375 treatment on platelet count over time
    To evaluate the effect of PF-06835375 on depletion of circulating B cells and cTfh cells over time
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age and Sex:
    1. Participants between the ages of 18 (or the minimum country-specific age of consent if >18) and 70 years, inclusive, at Screening.
    Type of Participant and Disease Characteristics:
    2. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures.
    3. Diagnosis of Primary ITP.
    ITP must be diagnosed in accordance with established guidelines. Ongoing ITP (platelet counts <50 x 109/L) [No severe bleeding within 1 month or during screening] AND Persistent ITP (3 to 12 months) or Chronic ITP >12 months.
    Weight:
    4. BMI 17.5 to 40 kg/m2, and minimum weight >40 kg (88 lbs).
    Informed Consent:
    5. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the ICD and in this protocol
    E.4Principal exclusion criteria
    Medical Conditions:
    1. Bleeding event according to the WHO grading scale 30 ≥2 occurring ≤4 weeks prior to screen OR a current bleeding event that, in the opinion of the investigator, requires treatment with standard of care therapy OR require blood or blood products during screening
    2. Splenectomy within 3 months of randomization or planned during the study duration.
    3. Have current or recent history of clinically significant, acute or chronic, severe, progressive, or uncontrolled renal, hepatic, gastrointestinal, metabolic, endocrine,
    pulmonary, cardiovascular, psychiatric, immunologic/rheumatologic 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 or study intervention administration, or interfere with the interpretation of study results; or in the opinion of the investigator, the participant is inappropriate for entry into this study.
    4. 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.
    15. Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s).
    16. Any prior treatment with rituximab (or any other B cell depleting agent) must have been completed 12 months prior to first dose of study drug and CD19 count
    (>100 cells per microliter) must be normal prior to first dose.
    5. Contraindication for the pre and post medication treatments (NSAID, APAP,corticosteroids, antihistamine).
    6. Pregnant female participants; breastfeeding female subjects; and female participants of childbearing potential who are unwilling or unable to use one method of
    contraception as outlined in this protocol for the duration of the study and for at least 43 days after the last dose of study intervention.
    7. Have a history of alcohol or substance abuse within 12 months prior to Day 1 that in the opinion of the investigator will preclude participation in the study or protocol adherence in the study. A positive urine drug screen must be reflective of a clinically appropriate use.
    8. Currently active autoimmune disorders or other conditions that compromise or impair the immune system (including but not limited to: CD, RA, scleroderma, vasculitis, SLE, Grave’s disease or asthma) in the opinion of the investigator.
    9. Co-existing myelodysplastic disorder. If clinically significant anemia, neutropenia, or pancytopenia exists, documentation of a bone marrow aspirate/biopsy within
    24 months prior to the first study dose showing no evidence of myelodysplasia is required.
    10. Co-existing thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, coagulopathies or other bleeding disorders.
    11. History of immune deficiency or current evidence of total IgG or total IgA deficiency.
    12. History of allergic or anaphylactic reaction to any components of the study intervention.
    13. Have cancer or a history of cancer within 5 years of screening (other than adequately resected cutaneous basal cell, squamous cell carcinoma, or carcinoma in situ of the uterine cervix with no evidence of recurrence within the previous 3 years).
    14. Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria: Suicidal ideation associated with actual intent and a method or plan in the past year: “Yes” answers on items 4 or 5 of the C-SSRS. Previous history of suicidal behaviors in the past 5 years: “Yes” answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C-SSRS.Any lifetime history of serious or recurrent suicidal behavior.
    15. Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s).
    16. Any prior treatment with rituximab (or any other B cell depleting agent) must have been completed 12 months prior to first dose of study drug and CD19 count
    (>100 cells per microliter) must be normal prior to first dose.
    17. Recent high doses corticosteroids (> 20 mg prednisone or equivalent per day). If on corticosteroids, must be on a stable dose for ≥28 days prior to the first dose
    (maximum dose up to 20 mg/day prednisone equivalent) and expected to remain on a stable dose throughout the study.
    18. Treatment with IVIg ≤28 days prior to the first dose.
    19. Treatment with plasmapheresis within 3 months prior to the first dose.
    20. Treatment with an anti-Rh D antigen agent (eg, WinRho®) ≤28 days prior to the first dose.
    Further exclusion criteria are detailed in the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Log2 (platelet count) at Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    Modified overall response (mOR) at Week 12
    Complete response (CR) at Week 12
    Incidence of AEs as characterized by type, frequency, severity, timing,
    seriousness, and relationship to study intervention, Day 1 through end of study
    Log2 (platelet count)
    Modified response (mOR)
    Complete response (CR)
    Absolute values and change of platelet count from baseline
    Absolute values and change from baseline of circulating B and Tfh cell counts
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    Week 12
    Day 1 through end of study
    The secondary endpoints/estimands will include evaluation of expected value (with 90% confidence intervals) for means of log2(Platelet counts) and proportions of mOR and CR responders over time. Censoring of the log2 (Platelet counts), definitions of mOR and CR responses will be similar and methods for the analysis (MMRM and Wald) will be the same as the methods described in the Section 9.3.2 for the key secondary endpoints. The only difference will be that the MMRM model will use the data collected at all available visits rather than the data collected up to and including Week 12 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 No
    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 Yes
    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 No
    E.8.1.1Randomised Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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 Yes
    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
    Czechia
    Hungary
    Poland
    United States
    E.8.7Trial has a data monitoring committee No
    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 end of the study is defined as the date of the last visit of the last participant in the study or last scheduled procedure shown in the Schedule 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 months7
    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 months10
    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 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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 40
    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 intervention will be provided to study participants at the end of their study participation
    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 Decision2022-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-09
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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