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    Summary
    EudraCT Number:2019-003999-39
    Sponsor's Protocol Code Number:C2501003
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-04-29
    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 ConcernedNorway - NOMA
    A.2EudraCT number2019-003999-39
    A.3Full title of the trial
    A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN 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 placebo-controlled study followed by an open label treatment to evaluate the safety and efficacy of PF-06826647 in participants with moderate to severe ulcerative colitis
    A.4.1Sponsor's protocol code numberC2501003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04209556
    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+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-06826647
    D.3.2Product code PF-06826647
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPF-06826647
    D.3.9.2Current sponsor codePF-06826647
    D.3.9.4EV Substance CodeSUB197888
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    moderate to severe ulcerative colitis
    E.1.1.1Medical condition in easily understood language
    moderate to severe form of ulcerative colitis, an inflammatory bowel disease that causes long-lasting inflammation and ulcers in the digestive tract
    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-06826647 in induction of endoscopic response in participants with moderate to severe ulcerative colitis (UC).
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of PF-06826647 in induction of clinical remission in participants with moderate to severe UC.
    • To evaluate the efficacy of PF-06826647 in induction of endoscopic remission in participants with moderate to severe UC.
    • To evaluate the efficacy of PF-06826647 in induction of mucosal healing in participants with moderate to severe UC.
    • To evaluate the efficacy of PF-06826647 in induction of clinical response with participants with moderate to severe UC.
    • To evaluate the efficacy of PF-06826647 in induction of clinical outcomes based on total/partial Mayo scores in participants with moderate to severe UC.
    • To evaluate the safety and tolerability of PF-06826647 in participants with moderate to severe UC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age and Sex:
    1. Male or female participants between the ages of 18 (or the minimum country specific age of consent if >18) and 75 years, inclusive, at Visit 1 (Screen 1).
    Type of Participant and Disease Characteristics:
    2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
    3. Diagnosis (endoscopic and histological) of UC for ≥3 months prior to entry into the study. A report supporting disease duration and extent (eg, proctosigmoiditis, left sided colitis, or pancolitis) based upon prior endoscopy including a biopsy report must be available in the source documentation.
    4. Participants with moderate to severe UC as defined by a total Mayo score (tMS) of ≥6, with a rectal bleeding subscore of ≥1 and an endoscopic subscore of ≥2 (any friability = 2).
    5. Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy).
    6. Participants must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC:
    • Oral, intravascular, or intramuscular corticosteroids;
    • Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]);
    • Anti tumor necrosis factor (TNF) inhibitors (eg, infliximab, adalimumab, or golimumab);
    • Anti integrin inhibitors (eg, vedolizumab);
    • JAK inhibitor (eg, tofacitinib);
    • Anti-IL-12/IL-23 inhibitors (eg, ustekinumab).
    Local standards of care, as well as investigator assessment should be considered in any assessment.
    7. Participants currently receiving permissible treatment for UC are eligible providing they have been on stable doses.
    8. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    Weight:
    9. Body weight must be >40 kg.
    Informed Consent:
    10. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document and in the protocol.
    E.4Principal exclusion criteria
    1. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, or clinical findings suggestive of Crohn’s disease.
    2. Participants with known colonic stricture and participants with history of colonic or small bowel obstruction, resection, or stoma.
    3. Participants with significant trauma or major surgery within 4 weeks of screening or planned a surgery during the study.
    4. Participants with a history of bowel surgery within 6 months prior to baseline.
    5. Participants displaying clinical signs of fulminant colitis or toxic megacolon.
    6. Participants with primary sclerosing cholangitis.
    7. Participants with evidence of colonic dysplasia, adenomas or neoplasia. However, participants with adenomatous polyps identified on screening endoscopy will be eligible if the polyps have been completely removed and pathologic report is negative.
    8. Participants with any condition possibly affecting oral drug absorption (eg, gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass). Procedures such as gastric banding that simply divide the stomach into separate chambers are NOT exclusionary.
    9. Have current or recent (within the past year) history of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, immunologic (eg, Felty’s syndrome) or neurologic disease, including but not limited to the following:
    • History of acute coronary syndrome (eg, myocardial infarction, unstable angina pectoris) or any history of cerebrovascular disease within 24 weeks before screening;
    • Chronic heart failure New York Heart Association Grade IV;
    • History of liver cirrhosis;
    • History of recurrent (≥2) venous thrombosis or any arterial thromboembolism or known blood clotting disorders.
    10. Cancer or history of cancer or history of any lymphoproliferative disorder (such as Epstein-Barr virus [EBV]-related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease), except for participants with adequately treated or excised non-metastatic basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.
    11. Infected with Mycobacterium tuberculosis (TB): History of multidrug resistant TB infection, any evidence of untreated, inadequately treated latent or active TB infection.
    • A participant who is currently being treated for active TB infection is to be excluded.
    • A participant who is currently being treated for latent TB infection with an adequate TB treatment regimen in the locale (in the opinion of the appropriately qualified personnel- which may include a pulmonary or infection disease specialist, or locally acceptable expert as defined by local guidelines) for at least 1 month can only be enrolled with documentation of treatment regimen, commitment of continuing treatment during the study and with prior approval by the sponsor.
    12. History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
    13. Clinically significant infections within 3 months of baseline (eg, those requiring hospitalization or parenteral antimicrobial therapy, or opportunistic infections), or a history of any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study.
    14. Presence of transplanted organ; skin grafts are allowed.
    15. 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 investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
    16. Have been vaccinated with live or attenuated live vaccine within the 6 weeks prior to the first dose of study drug or expects to be vaccinated with these vaccines during treatment, or within the 8 weeks following the last dose of study drug.
    17. Participants have received, are receiving or require treatment with prohibited prior/concomitant medications(s) including moderate to potent CYP1A2 and CYP3A4 inhibitors/inducers or CYP2D6 inhibitors or MATE substrates within certain time periods.
    18. 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).
    19. Participants who have been intolerant of selective TYK2 inhibitors will be excluded from the study.

    Further exclusion criteria are detailed in the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants achieving endoscopic response at Week 8.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 8
    E.5.2Secondary end point(s)
    • Proportion of participants with clinical remission based on 12-point or 9-point total Mayo score at Week 8.
    • Proportion of participants with endoscopic remission at Week 8.
    • Proportion of participants with mucosal healing at Week 8.
    • Proportion of participants with a clinical response at Week 8.
    • Partial Mayo scores and change from baseline over time at Weeks 2, 4 and 8.
    • Change from baseline at Week 8 in total Mayo score.
    • Incidence and severity of adverse events, serious adverse events and withdrawals due to adverse events at time points specified in the Schedule of Activities (SoA).
    • Incidence of serious infections at time points specified in the SoA.
    • Change from baseline in clinical laboratory values (chemistry, hematology & lipids) at time points specified in the SoA.
    • Incidence of clinically significant changes in Electrocardiogram (ECG) (heart rate, QT, QTc, PR and QRS intervals) at time points specified in the SoA.
    • Change from baseline in vital signs (blood pressure, pulse rate and temperature measurements) at time points specified in the SoA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Individual timepoints are included in each bullet point above with reference to the SoA, contained within section 1.3 of the clinical trial 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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Patient Reported Outcomes
    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 Yes
    E.8.1.7.1Other trial design description
    Open label extension treatment period
    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 trial4
    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 EEA46
    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
    Armenia
    Australia
    Belgium
    Bosnia and Herzegovina
    Brazil
    China
    Croatia
    Czech Republic
    France
    Georgia
    Germany
    Hong Kong
    India
    Ireland
    Italy
    Jordan
    Lebanon
    Macedonia, the former Yugoslav Republic of
    Malaysia
    Mexico
    Morocco
    Norway
    Oman
    Poland
    Puerto Rico
    Qatar
    Romania
    Russian Federation
    Saudi Arabia
    Slovakia
    Spain
    Tunisia
    Turkey
    Ukraine
    United Arab Emirates
    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
    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 of the protocol for the last participant in the study globally.
    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 months8
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days26
    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: 182
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 202
    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 difference from the expected normal treatment of that 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 Decision2020-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-09-24
    The status of studies in GB is no longer updated from 1.1.2021
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