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    Summary
    EudraCT Number:2017-004997-32
    Sponsor's Protocol Code Number:GA40209
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-18
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-004997-32
    A.3Full title of the trial
    A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE
    STUDIO DI ESTENSIONE IN APERTO, DI FASE II PER VALUTARE LA SICUREZZA E LA TOLLERABILITÀ A LUNGO TERMINE DI UTTR1147A IN PAZIENTI AFFETTI DA COLITE ULCEROSA O MALATTIA DI CROHN DA MODERATA A GRAV
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease
    Studio per valutare la sicurezza e la tollerabilità a lungo termine di UTTR1147A in pazienti con colite ulcerosa o malattia di Crohn da moderata a grave
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberGA40209
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    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 SponsorGENENTECH, 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 supportGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number000000
    B.5.5Fax number0000000
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameUTTR1147A/RO7021610 (Active)
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeRO7021610
    D.3.9.4EV Substance CodeSUB179397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 typeProteina di fusione dell'interleuchina-22 (IL-22) umana
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative Colitis (UC) or Crohn's Disease (CD)
    Colite ulcerosa (CU) o malattia di Crohn (MC)
    E.1.1.1Medical condition in easily understood language
    UC and CD are forms of inflammatory bowel disease that causes inflammation and ulcers in the colon resulting in abdominal pain and bloody diarrhea
    CU e MC sono forme di malattia infiammatoria intestinale che causano infiammazione e ulcerazioni nel colon dando origine a dolore addominale e diarrea con sangue
    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 LLT
    E.1.2Classification code 10011402
    E.1.2Term Crohn's disease (colon)
    E.1.2System Organ Class 100000004856
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10033007
    E.1.2Term Other ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045366
    E.1.2Term Ulcerative colitis, unspecified
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066678
    E.1.2Term Acute ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10075635
    E.1.2Term Acute hemorrhagic 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 safety and tolerability of UTTR1147A
    Valutare la sicurezza e la tollerabilità di UTTR1147A
    E.2.2Secondary objectives of the trial
    - Prior enrollment in Study GA29469 or Study GA39925 and meeting protocol defined entry criteria
    - Ability to comply with requirements of the study, in the investigator's judgment
    - Age 18-80 years
    - For women and men: Use of highly effective contraception as defined by the protocol
    - Precedente arruolamento nello studio GA29469 o nello studio GA39925 e soddisfazione dei criteri di accesso definiti dal protocollo
    - Abilità di soddisfare i reguisiti dello studio, a giudizio dello sperimentatore
    - Età 18-80 anni
    - Per donne e uomini: uso di contraccezione altamente efficace come definito dal protocollo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Prior enrollment in Study GA29469 or Study GA39925 and meeting
    protocol defined entry criteria
    - Ability to comply with requirements of the study, in the investigator's
    judgment
    - Age 18-80 years
    - For women and men: Use of highly effective contraception as defined
    by the protocol
    - Precedente arruolamento nello studio GA29469 o nello studio GA39925 e soddisfazione dei criteri di accesso definiti dal protocollo
    - Abilità di soddisfare i reguisiti dello studio, a giudizio dello sperimentatore
    - Età 18-80 anni
    - Per donne e uomini: uso di contraccezione altamente efficace come definito dal protocollo
    E.4Principal exclusion criteria
    • Withdrawal of consent from parent study
    • Discontinuation of study drug as required by the parent study protocol
    • Discontinuation of study drug and withdrawal from Study GA29469 prior to Day 85 or from Study GA39925 prior to Week 8
    • Non compliance in the parent study, specifically defined as missing scheduled visits or non adherence with background medications and concomitant medications
    • Pregnant or breastfeeding, or intending to become pregnant during the study or within 8 weeks after the final dose of study drug or 18 weeks after final dose of study drug from Study GA39925 (due to the possibility of receiving vedolizumab), whichever is longer
    • Any new malignancy since enrolling in the parent study
    • Any new significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or GI disorders, since enrolling in the parent study
    • Any new signs or symptoms of infection judged by the investigator to be clinically significant since enrolling in the parent study
    • Ritiro del consenso relativo allo studio originario
    • Interruzione del farmaco dello studio richiesta dal protocollo dello studio originario
    • Interruzione dell’assunzione del farmaco in studio e ritiro dallo Studio GA29469 prima del Giorno 85 o dallo Studio GA39925 prima della Settimana 8
    • Non conformità nell’ambito dello studio originario, definita nello specifico come mancata presentazione a visite programmate o non aderenza ai farmaci di fondo e ai farmaci concomitanti
    • Stato di gravidanza o allattamento, oppure avvio di una gravidanza programmato durante lo studio o entro 8 settimane dopo l’ultima dose di farmaco dello studio o 18 settimane dopo l’ultima dose di farmaco dello studio ricevuta nello studio GA39925 (a causa della possibilità di ricevere vedolizumab), a seconda di quale sia il periodo più lungo
    • Qualsiasi tumore maligno di nuova insorgenza dopo l’arruolamento nello studio originario
    • Qualsiasi comorbilità di nuova insorgenza significativa e non controllata, per es. disturbi cardiaci, polmonari, renali, epatici, endocrini o GI, dopo l’arruolamento nello studio originario
    • Nuovi segni o sintomi di infezione giudicati clinicamente significativi dallo sperimentatore dopo l’arruolamento nello studio originario
    E.5 End points
    E.5.1Primary end point(s)
    1. Occurrence and severity of adverse events, with severity determined
    according to National Cancer Institute Common Terminology Criteria for
    Adverse Events scale
    2. Change in targeted vital signs, physical findings, and clinical
    laboratory test results during and following UTTR1147A administration
    1. Manifestazione e gravità di eventi avversi, la cui gravità sia stata determinata secondo la scala dei criteri terminologici comuni per gli eventi avversi dell’istituto tumori nazionale (National Cancer Institute Common Terminology Criteria for Adverse Events)
    2. Variazione in segni vitali mirati, nonché nei reperti obiettivi e nei risultati dei test clinici di laboratorio durante e dopo la somministrazione di UTTR1147A
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2. Up to 1 year
    1-2. Fino a 1 anno
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity; Identification of biomarkers that can increase the knowledge and understanding of disease biology
    Immunogenicità; identificazione dei biomarcatori che possono aumentare la conoscenza e la comprensione della biologia della malattia
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    In aperto
    In aperto
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    Russian Federation
    Serbia
    Ukraine
    United States
    Bulgaria
    France
    Germany
    Greece
    Hungary
    Ireland
    Italy
    Poland
    Spain
    United Kingdom
    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 when the last patient completes his or her final study visit.
    La fine dello studio è definita come la data in cui l’ultimo paziente completa la sua ultima visita dello studio.
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    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: 272
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 112
    F.4.2.2In the whole clinical trial 320
    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)
    Currently, the Sponsor (Genentech, a member of the Roche Group) does not have any plans to provide Genentech IMP (UTTR1147A) or any other study treatments or interventions to patients who have completed the study. The Sponsor may evaluate whether to continue providing UTTR1147A in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product.
    Attualmente lo sponsor (Genentech, parte del gruppo Roche) non ha in programma di fornire l'IMP Genentech (UTTR1147A) o qualsiasi altro trattamento o intervento in studio ai pazienti che hanno completato lo studio. Lo sponsor potrebbe valutare se continuare a fornire UTTR1147A in conformità con la politica globale di Roche sull’accesso continuato al prodotto medicinale sperimentale.
    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 Decision2018-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-05-20
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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