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    Summary
    EudraCT Number:2017-002108-28
    Sponsor's Protocol Code Number:B7581002
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-03-22
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-002108-28
    A.3Full title of the trial
    A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission
    A.3.2Name or abbreviated title of the trial where available
    BUILD UC
    A.4.1Sponsor's protocol code numberB7581002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03269695
    A.5.4Other Identifiers
    Name:IND NumberNumber:122507
    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, New York 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 Center
    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.5.6E-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 nameDekavil
    D.3.2Product code PF-06687234
    D.3.4Pharmaceutical form Powder for 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-06687234
    D.3.9.2Current sponsor codePF-06687234
    D.3.9.3Other descriptive nameF8IL10
    D.3.9.4EV Substance CodeSUB177242
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 typehuman monoclonal antibody-cytokine fusion protein F8IL10
    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 placeboPowder for solution 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
    Ulcerative colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis
    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 efficacy of PF-06687234 in induction of clinical remission in subjects with UC and a partial response to anti-TNF-α;
    • To evaluate the safety and tolerability of PF-06687234 in subjects with UC and a partial response to anti-TNF-α.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of PF-06687234 in induction of endoscopic improvement in subjects with UC and partial response to anti-TNF-α;
    • To evaluate histological improvement in subjects with UC and partial response to anti-TNF-α;
    • To evaluate the efficacy of PF-06687234 in induction of clinical response in subjects with UC and a partial response to anti-TNF-α.
    • To describe the PK of PF-06687234 in subjects with UC.
    • To evaluate the immunogenicity of PF-06687234 in subjects with UC.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    “Pharmacokinetic substudy” with primary objective to assess pK of administered IP
    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. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
    3. Male and/or female subjects ≥18 years to ≤75 years of age and weight > 40 kg at the time of informed consent. For subjects in South Korea: male and/or female ≥19 years to <70 years of age and weight >40 kg at the time of informed consent.
    4. A diagnosis of active UC (histologic) for ≥4 months. A biopsy report supporting the diagnosis prior to the baseline visit must be available in the source documents. In addition, a report documenting disease duration and extent of disease (eg, proctosigmoiditis, left-sided colitis, or pancolitis) based upon prior endoscopy must also be available in the source documentation.
    5. Subjects who have partial response to anti-TNF (infliximab) and active UC as defined by (via screening endoscopy) a total Mayo Score ≥4 but ≤
    9 and an endoscopic subscore ≥2. Endoscopy (flexible sigmoidoscopy or colonoscopy), should be performed within 14 days of baseline (Day 1).
    The endoscopic Mayo subscore assessed by the Central Reader must be available at the baseline visit. The assessment by the Central Reader will
    be used to derive the total Mayo score to determine study eligibility.
    Primary non-responder to anti-TNF therapy should be excluded.
    6. UC extending at least 15 cm proximal to the anal verge at the time of the screening endoscopy.
    7. Must be on a stable dose 5- to 10 mg/kg of Remicade® or protocol specified infliximab biosimilars (see Protocol Appendix 5) for a minimum
    of 14 weeks prior to study entry with no anticipation of need for change in infliximab treatment regimen throughout the study (no switches from
    infliximab version at baseline to a different infliximab version will be permitted through Week 12). For a subject who has recently switched
    dose or dosing intervals of infliximab during maintenance therapy, the subject must be on the same dose and dosing interval for at least two
    treatment cycles (minimum 12 weeks) before study entry. Subject must maintain the same infliximab regimen of every 6 weeks or every 8 weeks
    throughout the study.
    8. Subjects currently receiving the following treatment for UC are eligible provided they have been on stable doses as described below:
    - Oral 5-aminosalicylic acid derivative (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 date of total Mayo Score assessment.
    - 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 date of total Mayo Score assessment. Decreases in steroid use due to AEs are allowed.
    - 6-MP, azathioprine (AZA) (≤ 2.5 mg/kg), or MTX stable dose for 8 weeks prior to baseline.
    9. Male subjects able to father children and female subjects of childbearing potential and at risk for pregnancy must agree to use two methods of contraception throughout the study and until the Week 16 visit (or 28 days after the last dose of IP).
    - Women of childbearing potential (WOCBP) will be eligible provided these women use two methods of contraception throughout the study and until the Week 16 visit (or 28 days after the last dose of IP), as outlined in Protocol Section 4.4.
    - Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:
    -Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;
    - Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    - Have medically confirmed ovarian failure.
    All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
    E.4Principal exclusion criteria
    1. Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use 2 methods of contraception as per protocol for the duration of the study (Wk16 visit) or for at least 28days after the last dose of IP
    2. Subjects with a diagnosis or documented history of total colectomy and/or pouchitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, or clinical findings suggestive of Crohn’s disease
    3. Subjects considered in imminent need for surgery or with major elective surgery scheduled to occur during the study
    4. Subjects with extensive colitis for at least 8yrs who have not had a colonoscopy with surveillance biopsies within 2yrs of the baseline visit
    5. Subjects with history of or at screening endoscopy, biopsy documented colonic dysplasia or neoplasia. Subjects with prior history of adenomatous polyps will be eligible if the polyps have been completely removed and pathology is negative
    6. Subjects who require infliximab dosing interval other than every 8wks during this study
    7. Subjects displaying clinical signs of fulminant colitis or toxic megacolon
    8. Subjects with primary sclerosing cholangitis
    9. Subjects with known colonic stricture, or history of colonic or small bowel obstruction or resection
    10. Subjects with history of or current colonic or small bowel stoma
    11. History of known cyclic neutropenia, thrombocytopenia, lymphopenia, leukopenia or any history of chronic anemia (HGB<10g/dL) which is judged by the investigator to have an unclear specific etiology or is non self-limiting
    12. 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 12wks prior to screening. Documentation of the official reading must be located and available in the source documentation
    13. Current evidence of active TB or latent TB infection or inadequately treated TB infection demonstrated by chest x-ray, a positive Mantoux(PPD) tuberculin skin test or a positive Interferon Gamma Release Assay during screening or within 12wks prior to randomization. The following are acceptable assays: QFT-G, QFT-GIT and T-SPOT® - TB test during screening or within 12wks prior to screening.
    14. Presence of active enteric infections (positive stool culture and sensitivity). The presence of Clostridium difficile infection or pseudomembranous colitis or history of recurrent Clostridium difficile infection. Known active invasive fungal infections such as histoplasmosis or parasitic infections.
    15. Known history of HIV based on documented history with positive serological test, or positive HIV serologic test at screening, tested at the site’s local lab and as per local regulations
    16. Presence of transplanted organ; skin grafts are allowed
    17. Previous severe hypersensitivity reaction to infliximab or known hypersensitivity to inactive components of infliximab or to any murine protein.
    18. Exposure to a live (attenuated) vaccine within 30days prior to screening or anticipated need for any live (attenuated) vaccine during the study
    19. Significant concurrent medical condition at the time of baseline visit
    20. Subjects receiving the therapies described in Protocol Sec. 4.2 within the designated time period or are expected to receive any of these therapies during the study period
    21. Subjects with significant trauma or major surgery within 4wks of screening
    22. Prior evidence of liver injury or toxicity due to methotrexate
    23. History of sensitivity to heparin or heparin-induced thrombocytopenia
    24. Abnormality in hematology and/or chemistry profiles during screening
    25. Donation of blood in excess of 500mL within 8wks prior to baseline
    26. History of alcohol or drug abuse with less than 6months of abstinence prior to baseline
    27. 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 subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study
    28. Participation in other studies involving IP(s) within 30days, or 5 half-lives of IP, prior to study entry and/or during study participation.
    29. Other acute or chronic medical or psychiatric condition including recent or active suicidal ideation or behavior 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
    30. Known history of hypersensitivity, intolerance, or allergic reaction to PF-06687234 or any constituent of the IP
    E.5 End points
    E.5.1Primary end point(s)
    • Proportion of subjects in clinical remission at Week 12 (as defined by a modified total Mayo Score with traditional endoscopic subscore ≤1, stool frequency subscore ≤1 and rectal bleeding subscore = 0).
    • Incidence and severity of adverse events, serious adverse events and withdrawals due to adverse events, ECGs, vital signs and safety laboratory tests.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be analyzed at Week 12 using exact Chan and Zhang method. The difference between treatment groups in the proportion of subjects in remission at Week 12 will be presented along with its 95% confidence interval. Subjects with missing remission data at Week 12 will be treated as treatment failure. As sensitivity analyses, the primary endpoint will also be analyzed using other methods for handling missing data which will be described in the SAP.
    All clinical AEs, SAEs, TEAEs, withdrawal due to AEs, ECGs (on weeks 6,12,16), vital signs and safety laboratory data (on weeks 1,2,4,6,8,10,12,16) will be reviewed and summarized on an ongoing basis in a blinded manner during the study to evaluate the safety of subjects.
    E.5.2Secondary end point(s)
    • Proportion of subjects with endoscopic improvement at Week 12 (defined as decrease of ≥1 point in a modified endoscopic subscore or an absolute endoscopy score of ≤1).
    • Mean change from baseline at Week 12 in Geboes histology score.
    • Proportion of subjects with a clinical response at Week 12 defined with a decrease from baseline of at least 3 points in total Mayo score with at least 30% change, accompanied by at least one point decrease or absolute score of 0 or 1 in rectal bleeding subscore.
    • Proportion of subjects with change from baseline in partial Mayo Score of ≤2 with no individual subscore >1 at Weeks 2, 4, 6, 8, 12.
    • Serum concentrations of PF-06687234.
    • Incidence of the development of HAFAs and Nabs against PF-06687234.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The proportion of subjects achieving endoscopic improvements or clinical response will be analyzed using same approach as for primary endpoint.
    Change from baseline at Week 12 in Geboes histology score will be analyzed using analysis of covariance model with treatment group and baseline scores. Proportions of subjects with partial Mayo Score will be analyzed using generalized linear mixed effect model with treatment group, visit, treatment group by visit interaction and subjects as random effect.
    PK concentration population: as all enrolled subjects who received at least one IP dose and in whom at least one concentration value is reported.
    Immunogenicity assessment population: as all enrolled subjects who received at least one IP dose with at least one post-treatment HAFA determination.
    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 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, histological improvement, immunogenicity
    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 Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Belgium
    Germany
    Israel
    Italy
    Korea, Republic of
    Saudi Arabia
    Serbia
    Spain
    United States
    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
    End of trial in EU 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 and ethics applications 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.
    End of trial in all other participating countries is defined as LSLV.
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 69
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 76
    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 Decision2018-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-07
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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