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    Summary
    EudraCT Number:2017-002274-39
    Sponsor's Protocol Code Number:A3921288
    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:2017-12-19
    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 number2017-002274-39
    A.3Full title of the trial
    A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission
    A.4.1Sponsor's protocol code numberA3921288
    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 number0018007181021
    B.5.5Fax number001303739 1119
    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 Yes
    D.2.1.1.1Trade name XELJANZ
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTofacitinib citrate
    D.3.2Product code CP-690,550-10
    D.3.4Pharmaceutical form Film-coated 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 INNtofacitinib
    D.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550-10
    D.3.9.3Other descriptive nameCP-690,550
    D.3.9.4EV Substance CodeSUB20282
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboFilm-coated tablet
    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
    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 and safety of tofacitinib in subjects in stable remission on 10 mg BID who decrease the dose to and remain on 5 mg BID (“5 mg BID dose group”) compared to subjects remaining on 10 mg BID.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy and safety of tofacitinib in subjects in stable remission on 10 mg BID who decrease the dose to 5 mg BID with option for dose escalation for flare (“flexible dosing regimen”) compared to subjects staying on 10 mg BID.
    • To evaluate the efficacy and safety of the subset of subjects in stable remission on 10 mg BID who have flare after dose decrease to tofacitinib 5 mg BID and are re-treated with 10 mg BID.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects currently enrolled in Study A3921139 who have received tofacitinib 10 mg BID for a minimum of 2 consecutive years in Study A3921139 prior to and including baseline of Study A3921288.
    2. Subjects who are in stable remission on tofacitinib 10 mg BID for the 6 month period in Study A3921139 up to and including baseline of Study A3921288, defined as meeting all of the following criteria:
    a. A partial Mayo score ≤2, with no individual subscore >1 and a rectal bleeding subscore of 0 at each study visit where data is available during the 6 month period in Study A3921139 prior to and including baseline of Study A3921288;
    b. AND at least one assessment of remission based on Mayo score;
    • If an endoscopy was not completed ≤6 months prior to baseline of Study A3921288, then an endoscopy performed in Study A3921139 with an endoscopic subscore of 0 or 1, will be required prior to randomization into Study A3921288.
    • All available assessments based on Mayo score during this period must show remission.
    c. AND subjects must not be receiving any corticosteroid therapy for their UC for at least 4-weeks prior to baseline.
    3. Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. Subjects in Canada who are women of childbearing potential and sexually active must use two contraceptive methods at the same time: one highly effective contraceptive method and one additional effective contraceptive method (see Protocol Section 4.4.4).
    4. Female subjects of childbearing potential must have a negative urine pregnancy test prior to randomization.
    5. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, bowel movement diary calls, and other study procedures.
    6. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
    E.4Principal exclusion criteria
    1. Subjects who were initially assigned to tofacitinib 10 mg BID at baseline of Study A3921139 whose tofacitinib dose was reduced to 5 mg BID due to safety or efficacy.
    2. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn’s disease.
    3. Subjects who in the opinion of the investigator are likely to require surgery for UC during the study period.
    4. Subjects who are expected to receive any prohibited medications, including medications that are either moderate to potent CYP3A inducers or inhibitors, during the study period as specified in the protocol (see Protocol Appendix 3).
    5. Subjects who are expected to receive live or attenuated virus vaccination during study period and for 6 weeks after last dose of investigational product.
    6. Women who are pregnant or breastfeeding, or planning to become pregnant during the study period.
    7. Subjects with evidence of colonic malignancy or any dysplasia (eg, “flat dysplasia”; polyp) identified on endoscopic exam during Study A3921139. Subjects with completely resected adenomatous polyp(s) outside of (proximal to) the extent of colitis may be eligible upon consultation with the sponsor. Note, pathology report must be reviewed prior to subject enrolment.
    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 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.
    9. 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.
    10. Subjects who, in the opinion of the investigator or Pfizer, will be uncooperative or unable to comply with study procedures.
    11. Participation in other studies, excluding study A3921139, involving investigational drug(s) during study participation.
    12.Subjects with any of the following risk factors for pulmonary embolism at baseline as defined by EMA's PRAC (per Amendment 2 only):
    • has heart failure
    • has inherited coagulation disorders
    • has had venous thromboembolism, either deep venous thrombosis or
    pulmonary embolism
    • is taking combined hormonal contraceptives or hormone replacement
    therapy
    • has malignancy (association is strongest with cancers other than nonmelanoma
    skin cancers)
    •
    is undergoing major surgery.

    E.5 End points
    E.5.1Primary end point(s)
    Remission based on modified Mayo score at Month 6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis will be performed at Month 6 based on the FAS for the estimation of treatment difference between two dose groups: Tofacitinib 10 mg BID and Tofacitinib 5 mg BID.
    The stratified estimation of the treatment difference between tofacitinib 10 mg BID and 5 mg BID in the proportion of subjects with remission at Month 6 will be presented along with its 95% confidence interval (CI). The Cochran-Mantel-Haenszel (CMH) weight method will be used for the stratified estimation of the treatment difference. The stratified CI will be constructed using the NewCombe method. Subjects with dose escalation prior to Month 6 or with missing values at Month 6 will be treated as non-responders at Month 6.
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    • Time to loss of remission based on modified Mayo score.
    • Remission at all applicable scheduled visits based on the following: modified Mayo score (excluding Month 6), modified partial Mayo score, total Mayo score, and partial Mayo score.
    • Change from baseline (of Study A3921288) at all applicable scheduled visits in the following: modified Mayo score, modified partial Mayo score, total Mayo score, and partial Mayo score.
    • Mucosal healing at all applicable scheduled visits.
    • Clinical response based on Mayo score at all applicable scheduled visits.
    • Change from baseline at all applicable scheduled visits in fecal calprotectin and hs-CRP levels.
    For additional safety endpoints please refer to the study protocol.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For efficacy endpoints based on Mayo score, the change from baseline will be analyzed using an analysis of covariance model with treatment group, the endoscopic subscore at baseline (0 versus 1) as factors and baseline score as a covariate. For other endpoints, the change from baseline will be analyzed using linear mixed-effects model with baseline value, treatment group, the endoscopic subscore at baseline (0 versus 1), visit, and treatment group by visit interaction all as fixed effects, and an unstructured covariance matrix for within-subject measurements over visits. The adjusted estimations and associated 95% CI for the overall difference between the two groups will be computed.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Austria
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Japan
    Korea, Republic of
    Netherlands
    New Zealand
    Poland
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Ukraine
    United Kingdom
    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 (EOT) in a Member State of 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 application and ethics application in the Member State.
    EOT in all other participating countries is defined as Last Subject Last Visit which is the last follow up visit for the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days6
    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: 127
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 130
    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 Decision2017-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-18
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