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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41470   clinical trials with a EudraCT protocol, of which   6815   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2018-004491-35
    Sponsor's Protocol Code Number:INCB39110-210
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-07-03
    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 number2018-004491-35
    A.3Full title of the trial
    A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis
    Badanie fazy II prowadzone metodą podwójnie ślepej próby, z grupą kontrolną otrzymującą placebo i etapem rozszerzającym prowadzonym metodą otwartej próby, mające na celu ustalenie dawki optymalnej oraz ocenę bezpieczeństwa i skuteczności itacitynibu w leczeniu wrzodziejącego zapalenia jelita grubego o nasileniu od umiarkowanego do ciężkiego
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating safety and efficacy of Itacitinib as treatment of moderate to severe ulcerative Colitis
    A.4.1Sponsor's protocol code numberINCB39110-210
    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 SponsorIncyte Corporation
    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 supportIncyte Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIncyte Corporation
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address1801 Augustine Cut-Off
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE 19803
    B.5.3.4CountryUnited States
    B.5.5Fax number13024252734
    B.5.6E-mailRA@incyte.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 nameItacitinib
    D.3.2Product code INCB039110
    D.3.4Pharmaceutical form Modified-release 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 INNITACITINIB ADIPATE
    D.3.9.1CAS number 1334302-63-4
    D.3.9.2Current sponsor codeINCB039110 ADIPATE
    D.3.9.3Other descriptive nameITACITINIB ADIPATE
    D.3.9.4EV Substance CodeSUB184194
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 itacitinib in inducing a Clinical Response in participants with moderate to severe Ulcerative Colitis.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of itacitinib on endoscopic, clinical, and Quality of Life outcomes in participants with moderate to severe UC.
    - To explore the safety and tolerability of itacitinib in participants with UC.
    - To explore the PK of itacitinib in participants with UC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants must be ≥ 18 to < 75 years of age.
    2. Have a confirmed diagnosis of UC at least 12 weeks before screening based on clinical, endoscopic, and histopathological evidence. A biopsy report supporting the diagnosis must be available in the participant's source documents.
    3. Have a 3-component Mayo score of 4 to 9, which includes an mMES score of ≥ 2 as determined by a central reader, a rectal bleeding score of ≥ 1, and a stool frequency score of ≥ 1.
    4. Participants must have failed or be intolerant to (discontinued the medication due to an AE as determined by the investigator) at least 1 of the following treatments for UC within 5 years of the screening visit:
    a. Oral corticosteroids.
    b. AZA or 6-MP.
    c. Biologic therapy (eg, infliximab, vedolizumab, or adalimumab).
    5. Participants currently receiving the following treatment(s) for UC are eligible, provided they have been receiving and are anticipated to continue on stable dose(s):
    a. Oral 5-ASA (mesalamine up to 4.8 mg/kg per day) or sulfasalazine (up to 3 g/day) on a stable dose for at least 28 days before the screening visit and during the study.
    b. Oral corticosteroids (less than 30 mg/day prednisone or oral corticosteroid equivalent) on a stable dose for at least 14 days before the screening visit and during the study, or, if started less than 8 weeks before the screening visit, must be on a stable dose for at least 4 weeks before the screening visit.
    E.4Principal exclusion criteria
    1. Displaying clinical signs of fulminant colitis or toxic megacolon.
    2. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical or radiographic findings suggestive of Crohn's disease.
    3. Participants with disease limited to the distal 15 cm of the colon.
    4. Participants receiving (or expected to receive) the following therapies within the designated timeframe below before the baseline visit or during the study:
    a. 1 year (52 weeks): Anti-adhesion molecule therapy (eg, natalizumab, vedolizumab, or any investigational anti-adhesion molecule therapy).
    b. 8 weeks:
    − Anti-TNF therapy (eg, infliximab, adalimumab, golimumab, or certolizumab).
    − Interferon therapy.
    c. 4 weeks:
    − Cyclosporine, mycophenolate, or tacrolimus.
    − A daily dose of oral corticosteroids ≥ 30 mg prednisone or equivalent.
    − Intravenous corticosteroids.
    d. 2 weeks:
    − Rectally administered formulation of corticosteroids or 5-ASA.
    − AZA, 6-MP, or methotrexate
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants with a Clinical Response at Week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    • Proportion of participants with Endoscopic Response at Week 12.
    • Proportion of participants with Mucosal Healing at Week 12.
    • Proportion of participants in Endoscopic Remission at Week 12.
    • Proportion of participants in Clinical Remission at Week 12.
    • Proportion of participants in each category (0, 1, 2, or 3) for each of the 3‐component Mayo subscores (stool frequency, rectal bleeding, mMES).
    • Change from baseline at Week 12 in 3-component Mayo score.
    • Change from baseline to Week 12 in PGA score.
    • Change in Quality of Life score as measured by the IBDQ at Weeks 4 and 12.

    Monitoring the incidence, duration, and severity of AEs; performing physical examinations; collecting vital signs; and collecting ECGs and laboratory data for hematology, serum chemistry, and urinalysis.

    • Plasma concentrations of itacitinib at Weeks 2, 4, and 12 for determination of Cmin, Cmax and, data permitting, AUC0-τ, CL/F, Vz/F, half-life, and Tmax.
    • Stool concentrations of itacitinib at Week 4 following 24-hour collection.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 2, 4, 12
    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 Yes
    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) 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
    double-blind, randomized, placebo-controlled period followed by open label 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 trial6
    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 EEA10
    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
    Czech Republic
    Germany
    Poland
    Romania
    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
    The end of the study is defined as the date of the last visit of the last participant in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 206
    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)
    None
    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 Decision2019-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-11-13
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