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    Summary
    EudraCT Number:2012-004355-37
    Sponsor's Protocol Code Number:B5301001
    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:2013-01-09
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2012-004355-37
    A.3Full title of the trial
    A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06473871 IN REDUCING HYPERTROPHIC SKIN SCARRING
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to determine the effectiveness and safety of PF-06473871 in reducing raised skin scars in subjects who have had breast surgery
    A.4.1Sponsor's protocol code numberB5301001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01730339
    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 pointDirector, Clinical Trial Disclosure
    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.5.6E-mailMarla.Brickman@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-06473871 Injection, 25 mg/mL
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPF-06473871
    D.3.9.3Other descriptive nameEXC-001
    D.3.9.4EV Substance CodeSUB44258
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntradermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypertrophic skin scarring
    E.1.1.1Medical condition in easily understood language
    Raised skin scarring
    E.1.1.2Therapeutic area Body processes [G] - Integumentary System Physiological Phenomena [G13]
    MedDRA Classification
    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-06473871 compared to placebo, in reducing the severity of skin scarring in subjects undergoing an elective revision of hypertrophic scars resulting from prior breast surgery.
    E.2.2Secondary objectives of the trial
    • To assess the safety of PF-06473871 in subjects undergoing elective revision of hypertrophic scars resulting from prior breast surgery.
    • To evaluate the pharmacokinetics of PF-06473871.
    • To evaluate the operating characteristics and psychometric performance of the patient reported scar evaluation questionnaire (PR SEQ).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Additional Pharmacogenomic Research (Optional)

    Unless prohibited by local legislation, samples collected during the course of the study will be retained in the Pfizer BioBank. Subjects will be asked to specifically consent to allow the Retained Pharmacogenomic Sample(s) to used for the following future research:

    1. Investigations of the disease under study in the clinical trial, and related conditions.
    2. Samples may be used as controls. This includes use in case-control studies of diseases for which Pfizer is researching drug therapies; use in characterizing the natural variation amongst people in genes, RNA, proteins, and metabolites; and use in developing new technologies related to pharmacogenomics.

    Subjects may still participate in the current trial if they elect not to allow their Retained Pharmacogenomic Samples to be used for the above-described additional purposes.
    E.3Principal inclusion criteria
    1. Female and male subjects between 18-55 years of age, inclusive.
    2. Female subjects of childbearing potential must agree to use two highly effective methods of contraception throughout the duration of the 24 week study. A subject is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children. Female subjects who are not of childbearing potential must meet at least one of the following criteria):
    a. Have undergone hysterectomy or bilateral oophorectomy; or
    b. Have medically confirmed ovarian failure; or
    c. Are medically confirmed to be post menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause).
    3. Male subjects must agree to use one of the following effective method of contraception throughout the duration of the 24 week study:
    d. Male condom used with a spermicide.
    e. Male sterilization with appropriately confirmed absence of sperm in the postvasectomy ejaculate
    4. Subjects who have previously had breast surgery such as but not limited to breast reduction, breast augmentation, or mastopexy resulting in unacceptable bilateral scars no earlier than 6 months prior to Day 1 of the study and no later than 15 years.
    5. Subjects must have a pre-existing scar with a severity equivalent to a score of 3, 4, or 5 using the photoguide (Protocol Appendix 4), as rated by the surgeon physician. A separate, independent central reader rating of scars will be performed using the same photoguide. The central reader scores and agreement/disagreement will be documented. In the case of a disagreement between the surgeon physician and the central reader (and the physician challenges), the photos will be sent to the Pfizer clinician for adjudication. Final decision on subject eligibility will be documented in the eCRF.
    6. Subjects should have scars meeting the following criteria to qualify for inclusion in the study:
    a. Bilateral symmetrical scars (same anatomic location), both of which are to be surgically revised (difference in scar scores between left and right must have a Delta less than or equal to 1 on photoguide).
    b. Hypertrophic; both scars must be elevated above the surrounding skin.
    c. The location of scars to be revised and treated are in the same area of breast on both the left and right sides.
    d. Male subjects must agree to shave the treated area of the scars 24-48 hours prior to dosing and scar assessments.
    e. A continuous length of a minimum of either 4 to 6 cm, or 12 cm (continuous or two 6 cm sections) must be available for treatment (although the total length of each scar may be longer), and separated from the scar on the opposite side of the sternum by at least 3 cm.
    • Note: the 4 to 6 cm or 12 cm portion chosen for treatment can be anywhere along the breast scar except the areola, in order to meet this criterion.
    • Note: the investigator may choose to revise as much of the scar as deemed in the best interest of the subject, but only the 4 to 6 cm or 12 cm portion designated on each side will be the “study scar” that will receive treatment with PF 0648371 or placebo.
    7. Subject has chosen to have the appropriate portions of the breast scars revised.
    8. Subjects must be able to tolerate up to a 3 hour scar revision surgery under sedation and local tumescent anesthesia.
    9. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
    10. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, photography and other study procedures.
    E.4Principal exclusion criteria
    1. Subjects undergoing combined surgical procedures (such as concurrent abdominoplasty, etc). Replacement implants (+/- 25% of original size) are allowed at the time of scar revision surgery.
    2. Presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric abnormalities that would make the subject an inappropriate candidate for the study.
    3. Presence or history of breast cancer.
    4. Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin). A subject is considered cured if there has been no evidence of cancer recurrence in the previous 5 years.
    5. History of radiation treatment to the area of the breast scars.
    6. Pregnant females or pregnant during the last 6 months prior to inclusion in the study; breastfeeding females; males and females of childbearing potential not using two (2) methods of highly effective contraception or not agreeing to continue two (2) methods of highly effective contraception for the duration of the 24 week study.
    7. Previous exposure to PF-06473871.
    8. Heavy use of tobacco/ nicotine-containing products as defined as more than 10 cigarettes (or equivalent) per day.
    9. Subjects taking chronic steroids (injected or oral) or other immune modulators.
    10. Any previous history of adverse reaction to an oligonucleotide-based drug.
    11. Use of any prescription medication within 14 days or 5 half lives (whichever is longer) prior to Day 1 or planned while on study that in the investigator’s judgment could affect wound healing.
    12. Use of any over-the-counter (OTC) medication that in the investigator’s judgment could affect wound healing, including herbal products, within the 14 days or 5 half lives (whichever is longer) prior to Day 1 or planned while on study. (Protocol Appendix 5).
    13. Any subject with clinically significant ischemic changes, as assessed by the investigator, or with a QTc of >450 msec should be excluded from the study.
    14. Subjects with a history of skin sensitivity (dermatitis) to either the suture materials to be used or the dressings to be utilized during the course of this study.
    15. Subjects with uncontrolled diabetes or any other condition that would, in the opinion of the Investigator, render them a risky surgical candidate regarding poor wound healing.
    16. Subjects taking aspirin-containing products or other blood thinners.
    17. Subjects with skin conditions (eg, cutis laxa that could result in poor healing or widened scars).
    18. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
    19. Participation in other studies within the previous 60 days, or 5 times the plasma half life (if known) of the investigational drug (whichever is longer) before Screening and/or during study participation.
    20. History of anaphylactic reactions to study or surgical medications.
    21. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    Physician Global Assessment using the Physician Overall Opinion of the Patient and Observer Scar Assessment Scale (POSAS, 10-point scale) at Week 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 3 weeks prior to treatment, and at Week 8, 11, 18 and 24
    E.5.2Secondary end point(s)
    • Physician scar assessment using the complete POSAS (vascularity, pigmentation, thickness, relief, pliability, surface area, overall opinion on a 10-point scale) at Weeks 8, 11, 18 and 24 (same rater at all time points).
    • Patient Global Assessment: The subject overall opinion of the POSAS (10-point scale) at Weeks 8, 11, 18 and 24.
    • Patient-reported scar evaluation questionnaire (PR SEQ Symptoms and Appearance domains) at Weeks 8 and 24.
    • Physician & Patient Photoguide Scar Assessment (5 point scale) at Weeks 8, 11, 18 and 24.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints during the 24-week study period.
    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 No
    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 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Within-subject
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Germany
    Hungary
    Netherlands
    Spain
    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
    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 months2
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days5
    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: 100
    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 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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 100
    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 completion of the current study and 12 months following the initial revision, eligible patients will be offered the opportunity to enrol in an open-label extension study to receive a second scar revision surgery and treatment of either their IMP-treated or placebo scar with PF 06473871, or alternative therapy. If patients do not enter the open-label extension study, they will be treated as per the expected normal treatment of the 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 Decision2013-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-17
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