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    The EU Clinical Trials Register currently displays   43207   clinical trials with a EudraCT protocol, of which   7151   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2019-002698-74
    Sponsor's Protocol Code Number:B7541007
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-02-21
    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 ConcernedGermany - PEI
    A.2EudraCT number2019-002698-74
    A.3Full title of the trial
    A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,
    PLACEBO CONTROLLED DOSE-RANGING
    STUDY TO EVALUATE THE EFFICACY, SAFETY, AND
    PHARMACOKINETICS OF PF-06480605 IN ADULT
    PARTICIPANTS WITH MODERATE TO SEVERE
    ULCERATIVE COLITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis
    A.3.2Name or abbreviated title of the trial where available
    Tuscany 2
    A.4.1Sponsor's protocol code numberB7541007
    A.5.4Other Identifiers
    Name:US IND NumberNumber:129188
    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 number0018007181021
    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-06480605
    D.3.2Product code PF-06480605
    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 INNPF-06480605
    D.3.9.2Current sponsor codePF-06480605
    D.3.9.3Other descriptive nameAnti-TL1A
    D.3.9.4EV Substance CodeSUB181859
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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) Yes
    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 typePF-06480605 neutralizes the binding and subsequent signaling of TL1A to its functional receptor DR3 on immune cells of the innate and adaptive immune system.
    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 placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Adults with Moderate to Severe 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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10009888
    E.1.2Term Colitis (excl infective)
    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
    1. To evaluate the efficacy of PF-06480605 in induction of clinical remission at Week 14 in participants with moderate to severe active UC.
    2. To evaluate the safety and tolerability of PF-06480605 during the induction period (from baseline to Week 14) and during the chronic therapy period (from Week 14 to the End of Study Visit)
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of PF-06480605 in inducing remission at Week 14 in participants with moderate to severe active UC.
    2. To valuate the efficacy of PF-06480605 on endoscopic appearance at Week 14.
    3. To characterize the PK of PF-06480605 during the induction period. To evaluate disease and pathway related biomarkers (ie, hsCRP and fecal calprotectin and serum sTL1A)
    Tertiary Objectives
    1. To evaluate the effect of PF-06480605 on clinical outcomes and quality of life.
    2. To evaluate the effect of PF 06480605 compared to placebo on histopathology score.
    3. To collect non banked samples (eg, intestinal biopsies, stool for microbiome and metabolomic analysis, serum for analysis of proteins and metabolomic profiling and blood for RNA analysis) for exploratory research.
    4. To enable exploratory research through collection of banked biospecimens
    5 .To conduct additional exploratory immunogenicity assessments.
    6.To characterize the immunogenicity of PF-06480605


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female participants 18 to 75 years of age.
    2. A diagnosis of UC for ≥3 months with endoscopy and pathology reports supporting the diagnosis, disease duration, and extent of disease.
    3. Moderate to severe active UC as defined by a Total Mayo Score of ≥6, and an endoscopic subscore of ≥2.
    4. Active disease beyond the rectum (>15 cm from the anal verge).
    5. Failed or be intolerant of at least 1 of the following treatments.
    Steroids, Immunosuppressants (azathioprine [AZA],
    6-mercaptopurine [6-MP] or methotrexate [MTX]),
    Anti-TNF inhibitors (eg, infliximab, adalimumab, or golimumab),
    Anti-integrin inhibitors (eg, vedolizumab),
    Anti-IL-12/23 inhibitors (eg, ustekinumab),
    JAK inhibitors (eg, tofacitinib).
    Participants currently receiving treatments for UC are eligible providing they have been and are anticipated to be on stable dose for the duration of the study.
    6. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
    7. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.
    E.4Principal exclusion criteria
    1. Diagnosis of ischemic colitis, infectious colitis, radiation colitis,
    microscopic colitis, indeterminate colitis, or findings suggestive of Crohn’s disease (eg, skip lesions, fistulae/perianal disease, non-necrotizing granulomas, etc.).
    2. Clinical signs of fulminant colitis or toxic megacolon.
    3. Imminent need for surgery or with elective surgery scheduled to
    occur during the study.
    4. Evidence of colonic dysplasia, adenomas, or neoplasia
    5. Participants who meet either of the 2 criteria below are considered at risk for colonic dysplasia, adenomas, or neoplasia and must have a colonoscopy prior to randomization:
    a. If the participant has had extensive (ie greater than left sided) colitis for equal to or greater than 8 years or disease limited to left side of colon (ie distal to splenic flexure) for equal to or greater than 10 years, regardless of age, a colonoscopy within 1 year of screening visit is required to survey for dysplasia.
    b. If the participant is equal to or greater than 50 years of age, a colonoscopy within 10 years of screening is required to exclude adenomatous polyps.
    Participants with adenomatous polyps identified on screening endoscopy will be eligible after complete polypectomy and follow up surveillance per local guidelines is negative.
    Or, If the participant is over 50 years of age, a colonoscopy within 10 years of screening is required to exclude adenomatous polyps. Participants with adenomatous polyps identified on screening endoscopy will be eligible after complete polypectomy and follow-up surveillance per local guidelines is negative.
    6. Clinically significant infections within 6 months of baseline (eg those requiring hospitalization or parenteral antimicrobial therapy, or opportunistic infections)
    7. Cancer or history of cancer or lymphoproliferative disease within 5 years of baseline (with the exception of adequately treated or excised non-metastatic basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ).
    8. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or interfere with the interpretation of study results.
    9. Use of prohibted prior/concomitant medications
    10. Known exposure to anti-TL1A (PF 06480605) or any type of anti-TL1A therapy.
    11. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product used in this study (whichever is longer). Note: local regulations or other factors may require more than 30 days.
    12. A 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
    13. Chest Radiograph or computed tomography scan showing abnormalities.
    14. Infected with tuberculosis, (TB): Any evidence of untreated latent or active TB infection.
    15. Presence of active enteric infections: Known pathogenic bacterial, parasitic, fungal infections, including Clostridium difficile.
    16. Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses.
    17. Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat, if deemed necessary:
    • Hemoglobin 8.0 g/dL or hematocrit 30% (0.30 v/v);
    • Absolute lymphocyte count (ALC) 0.8 x 109/L (800/mm3);
    • Absolute neutrophil count (ANC) 1.2 x 109/L (1200/mm3);
    • Platelet count 100 x 109/L (100,000/mm3);
    • Aspartate aminotransferase, (AST) or alanine aminotransferase, (ALT) ≥2.0 times the upper limit of normal (ULN);
    • Total bilirubin level ≥1.5 times the ULN; participants with a history of Gilbert’s syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin in ≤ ULN
    18. History of alcohol or drug abuse (per the investigator’s discretion) that would prevent the participant from being compliant with study visits and required procedures.
    19. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants achieving clinical remission (defined as a Total Mayo Score ≤2, with no individual subscore >1) at Week 14.
    Incidence and severity of treatment emergent adverse events (TEAEs) during the induction period.
    Incidence of serious adverse events (SAEs)
    Incidence of AEs or SAEs leading to discontinuation
    Incidence of clinically significant abnormalities in vital signs, ECGs and laboratory values.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At weeks 14 and 56 unless otherwise specified above
    E.5.2Secondary end point(s)
    Proportion of participants achieving remission (FDA definition 1 - defined as endoscopic subscore = 0 or 1, stool frequency subscore = 0, and rectal bleeding subscore = 0) at Week 14.
    Proportion of participants achieving remission (FDA definition 2 - defined as endoscopic subscore = 0 or 1, ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 or 1, and rectal bleeding subscore = 0) at Week 14.
    Proportion of participants achieving endoscopic improvement (defined as endoscopic subscore = 0 or 1) at Week 14.
    Proportion of participants achieving endoscopic remission (defined as endoscopic subscore = 0) at Week 14.
    PF 06480605 trough concentrations during the induction period through Week 14.
    Change from screening in fecal calprotectin during the induction period through Week 14.
    Change from baseline in hsCRP during the induction period through Week 14.
    Change from baseline in serum sTL1A during the induction period through Week 14.
    Incidence of development of anti drug antibodies (ADAs) and neutralizing antibodies (NAbs) during the induction period through Week 14.
    Proportion of participants achieving sustained clinical remission (ie, clinical remission at both Week 14 and Week 56).
    Proportion of participants achieving remission (FDA definition 1 - defined as endoscopic subscore = 0 or 1, stool frequency subscore = 0, and rectal bleeding subscore = 0) at Week 56.
    Proportion of participants achieving sustained remission FDA definition 1 (ie, remission FDA definition 1 at both Week 14 and Week 56).
    Proportion of participants achieving remission (FDA definition 2 - defined as endoscopic subscore = 0 or 1, ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 or 1, and rectal bleeding subscore = 0) at Week 56.
    Proportion of participants achieving sustained remission FDA definition 2 (ie, remission FDA definition 2 at both Week 14 and Week 56).
    Proportion of participants achieving endoscopic improvement (defined as endoscopic subscore = 0 or 1) at Week 56.
    Proportion of participants achieving sustained endoscopic improvement (ie, endoscopic improvement at both Week 14 and Week 56).
    Proportion of participants achieving endoscopic remission (defined as endoscopic sub score = 0) at Week 56.
    Proportion of participants achieving sustained endoscopic remission (ie, endoscopic remission at both Week 14 and Week 56).
    PF 06480605 concentration from Week 14 through the End of Study Visit.
    Change from Week 14 in fecal calprotectin during the chronic therapy period through the End of Study Visit.
    Change from Week 14 in hsCRP during the chronic therapy period through the End of Study Visit.
    Change from week 14 in serum sTL1A during the chronic therapy period through the End of Study Visit.
    Incidence of development of anti drug antibodies (ADAs) and neutralizing antibodies (NAbs) from Week 14 through the End of Study Visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Individual timepoints as detailed above for each endpoint
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 trial9
    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 EEA49
    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
    Austria
    Belgium
    Bulgaria
    Canada
    China
    France
    Germany
    Hungary
    India
    Italy
    Japan
    Mexico
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Turkey
    Ukraine
    United Kingdom
    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
    A participant is considered to have completed the study if he/she has completed all phases of the study including; screening, induction phase, chronic therapy period, and the follow up portion of the study up through and including visit (Visit 18), approximately 12 weeks post last dose of IP. The end of the study is defined as the date of the last visit (Visit 18), by the last participant across all sites globally.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days16
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 240
    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 the study.
    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 Decision2020-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-10-25
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