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    Summary
    EudraCT Number:2016-001158-16
    Sponsor's Protocol Code Number:B7541002
    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:2016-09-21
    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 number2016-001158-16
    A.3Full title of the trial
    A PHASE 2A, MULTICENTER, SINGLE ARM, OPEN-LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test whether PF-06480605 is safe and improves symptoms in patients with ulcerative colitis
    A.4.1Sponsor's protocol code numberB7541002
    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, NY 10017
    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+18007181021
    B.5.5Fax number+13037391119
    B.5.6E-mailclinicaltrials.govcallcenter@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-06480605
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPF-06480605
    D.3.9.2Current sponsor codePF-06480605
    D.3.9.3Other descriptive namePF-06480605
    D.3.9.4EV Substance CodeSUB181859
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number42.5 to 57.5
    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 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 Yes
    D.3.11.13.1Other medicinal product typeHuman IgG1 monoclonal antibody
    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
    Ulcerative colitis (UC)
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis (UC) which is a type of inflammatory bowel disease.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    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 safety and tolerability of PF-06480605 in subjects with moderate to severe UC.
    - To evaluate the efficacy of PF-06480605 in induction of endoscopic improvement (as assessed by Mayo endoscopic subscore) at Week 14 in subjects with moderate to severe UC.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of PF-06480605 in induction of remission at Week 14 (defined as a total Mayo score ≤ 2 with no individual subscore > 1) in subjects with moderate to severe UC.
    - To evaluate the efficacy of PF-06480605 in induction of endoscopic remission at Week 14 (defined as a Mayo endoscopic subscore of 0) in subjects with moderate to severe UC.
    - To describe the PK of PF-06480605 in subjects with moderate to severe UC.
    - To evaluate the immunogenicity of PF-06480605 in subjects with moderate to severe UC.
    - To evaluate disease and pathway related biomarkers (ie, hsCRP and fecal calprotectin), and serum total sTL1A.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

    2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

    3. Male and/or female subjects between ≥18 and ≤75 years of age at the time of informed consent.

    4. Male subjects able to father children and female subjects of childbearing potential and at risk for pregnancy must agree to use two highly effective methods of contraception throughout the study and until the Week 26 visit (or 98 days after the last dose of IP).
    Women of childbearing potential (WOCBP) will be eligible for this study provided these women use two highly effective methods of contraception throughout the study and until the Week 26 visit (or 98 days after the last dose of IP), as outlined in Section 4.3.
    Female subjects who are not of childbearing potential (ie, meet at least 1 of the following criteria):
    •Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    •Have medically confirmed ovarian failure; or
    •Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state.
    Note: For subjects in france, WOCBP are NOT eligible for this study.
    5. A diagnosis of UC for ≥4 months. A biopsy report must be available to confirm the histological diagnosis in the subject’s source documentation. In addition, a report documenting disease duration and extent of disease (eg, proctosigmoiditis, left-sided colitis, and pancolitis) based upon prior endoscopy must also be available in source documentation.

    6. Subjects with moderate to severe active UC as defined (via screening colonoscopy) by a total Mayo score of ≥6, with a rectal bleeding subscore of ≥1 and an endoscopic subscore of ≥2 on the Mayo.

    7. Active disease beyond the rectum (>15 cm of active disease at the screening colonoscopy).

    8. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC:
    •Steroids;
    •Immunosuppressants (AZA [azathioprine], 6-MP, or MTX [methotrexate]);
    •Anti-TNF inhibitors (eg, infliximab, adalimumab, or golimumab);
    •Anti-integrin inhibitors (eg, vedolizumab).
    For subjects in The Netherlands: Subjects must have inadequate response to, loss of response to, or intolerance to at least one biological therapy, such as an anti-TNF inhibitor.
    9. Subjects currently receiving the following treatment for UC are eligible provided they have been on stable doses as described below:
    •Oral 5-ASA or sulfasalazine stable dose for at least 4 weeks prior to baseline. If oral 5-ASA treatment has been recently discontinued, it must have been stopped for at least 2 weeks prior to total Mayo score screening procedures.
    •Oral corticosteroids (prednisone equivalent up to 20 mg/day; budesonide up to 9 mg/day) stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to total Mayo core screening procedures. Decreases in steroid use due to AEs are allowed.
    •6-MP or AZA (≤2.5 mg/kg) stable dose for 8 weeks prior to baseline. Decreases due to AEs are permitted.
    E.4Principal exclusion criteria
    1. Subjects with a diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis or CD. Subjects with clinical findings suggestive of CD (eg, fistulae, granulomas on biopsy) are also excluded.

    2. Subjects with an imminent need for surgery or with elective surgery scheduled to occur during the study.

    3. Subjects with colonic dysplasia or neoplasia.

    4. Subjects with toxic megacolon.

    5. Subjects with primary sclerosing cholangitis.

    6. Subjects with known colonic stricture.

    7. Subjects with history of colonic or small bowel stoma.

    8. Subjects with a history of colonic or small bowel obstruction or resection.

    9. Abnormal findings on the chest x-ray film performed routinely before initiating a new biologic therapy, such as presence of tuberculosis (TB), general infections, heart failure, or malignancy. Chest x-ray examination may be performed up to 12 weeks prior to screening.

    10. Any current evidence of untreated latent or active TB infection, evidence of prior or currently active TB by chest x-ray, residing with or frequent close contact with individual(s) with active TB. Subjects who have a positive Mantoux (PPD) tuberculin skin test or a positive Interferon Gamma Release Assay (IGRA to be tested at the site’s local lab where feasible) during screening or within 12 weeks prior to randomization.

    11. Presence of active enteric infections (positive stool culture and sensitivity). The presence of Clostridium difficile or pseudomembranous colitis. Known active invasive fungal infections such as histoplasmosis or parasitic infections. Subjects with clinically significant underlying disease that could predispose the subjects to infections. A history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks before Day 1. Pyoderma gangrenosum is allowed.

    12. Known history of human immunodeficiency virus (HIV) based on documented history with positive serological test, or positive HIV serologic test at screening, tested at the site’s local lab.

    13. Presence of transplanted organ. Skin grafts to treat pyoderma gangrenosum are allowed.

    14. Significant concurrent medical condition as judged by the investigator at the time of screening or baseline visit.

    15. Prior evidence of liver injury or toxicity due to methotrexate.

    16. Abnormality in hematology and/or chemistry profiles during screening as defined in the protocol.

    17. Subjects receiving the following therapies within the designated time period or are expected to receive any of these therapies during the study period:
    •>9 mg/day of oral budesonide or >20 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.
    •IV, IM (parenteral), or topical (rectal) treatment of 5-ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.
    •Biologics including anti-TNF inhibitors as described below:
    - Infliximab within 8 weeks prior to baseline.
    - Adalimumab within 8 weeks prior to baseline.
    - Golimumab within 8 weeks prior to baseline.
    •Anti-integrin inhibitors (eg, vedolizumab) within 12 weeks prior to baseline.
    For subjects in France: Subjects must not have received any biologic treatment for at least 5 half-lives prior to first dose of PF-06480605. (eg, infliximab: 47.5 days, adalimumab: 70 days, golimumab: 70 days, vedolizumab: 125 days).
    •Other investigational procedure(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.

    18. Current or history within 2 years of serious psychiatric disease or alcohol or drug abuse.

    19. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.

    20. Participation in other studies involving investigational drug(s) within 30 days, or 5 half-lives of IP (whichever is greater), prior to baseline and/or during study participation.

    21. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or IP 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.

    Please refer to the protocol Section 4.2 for a complete list of exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    - Safety and tolerability of PF-06480605: Treatment-Emergent Adverse Event (TEAEs), withdrawal due to AEs, and SAEs will be reported.
    - Endoscopic improvement at Week 14 (defined as a Mayo endoscopic subscore of 0 or 1, and without friability).
    E.5.1.1Timepoint(s) of evaluation of this end point
    - The safety laboratory tests will be performed at times defined in the Schedule of Activities, page 20 of the protocol.
    - Endoscopic improvement will be assessed at Week 14
    E.5.2Secondary end point(s)
    - Remission at Week 14 (defined as a total Mayo score ≤ 2 with no individual subscore >1).
    - Endoscopic remission at Week 14 (defined as a Mayo endoscopic subscore of 0).
    - PF-06480605 plasma concentrations.
    - Incidence of development of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs).
    - Change from baseline in fecal calprotectin.
    - Change from baseline in hsCRP.
    - Change from baseline in serum total sTL1A.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Endoscopic remission will be assessed at Week 14
    - The laboratory tests will be performed at times defined in the Schedule of Activities, page 20 of the protocol.
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 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.8.3 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Belgium
    France
    Italy
    Korea, Republic of
    Netherlands
    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
    End of trial in a Member State of the European Union is defined as the time at which it is deemed that a sufficient number of subjects have been recruited and completed the study as stated in the regulatory application and ethics application in the Member State. Poor recruitment (recruiting less than the anticipated number in the CTA) by a Member State is not a reason for premature termination but is considered a normal conclusion to the study in that Member State.
    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 months0
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days9
    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: 37
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 39
    F.4.2.2In the whole clinical trial 50
    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)
    When the trial completes the patients will revert to the local standard of care for Ulcerative Colitis
    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 Decision2016-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-22
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