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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7259   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).

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    EudraCT Number:2020-005770-99
    Sponsor's Protocol Code Number:1368-0059
    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:2021-09-28
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-005770-99
    A.3Full title of the trial
    Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial
    to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic
    Crohn's Disease
    Studio di fase IIa, multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare l’efficacia di spesolimab (BI 655130) in pazienti con malattia di Crohn fibrostenotica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test whether spesolimab helps people with Crohn's disease who
    have symptoms of bowel obstruction
    Studio volto a verificare se spesolimab è utile per le persone affette da malattia di Crohn con sintomi di ostruzione intestinale
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number1368-0059
    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.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 supportBoehringer Ingelheim Italia S.p.A.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH&Co KG
    B.5.2Functional name of contact pointCT Disclosure & Data Transparency
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.4Telephone number+498002430127
    B.5.5Fax number+498008217119
    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 nameBI 655130
    D.3.2Product code [BI 655130]
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNSPESOLIMAB
    D.3.9.2Current sponsor codeBI 655130
    D.3.9.4EV Substance CodeSUB194324
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fibrostenotic Crohn's Disease
    malattia di Crohn fibrostenotica
    E.1.1.1Medical condition in easily understood language
    Crohn's disease
    malattia di Crohn
    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 PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that spesolimab is effective in maintaining Symptomatic
    Stenosis Response and/or inducing Radiographic Stenosis Response in
    patients with symptomatic CD-related small bowel stenosis, who have
    achieved Symptomatic Stenosis Response after standard medical
    Dimostrare che spesolimab è efficace nel mantenere la risposta in termini di stenosi sintomatica e/o nell’indurre una risposta in termini di stenosi radiografica in pazienti con stenosi sintomatica dell’intestino tenue correlata alla malattia di Crohn che hanno ottenuto una risposta in termini di stenosi sintomatica in seguito a terapia farmacologica standard.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male and female patients, 18 to 75 years when signing informed
    consent at screening
    - Established diagnosis of clinical CD prior to screening
    - Suspicion of symptomatic small bowel stenosis
    - Presence of abdominal pain after eating or limitation in amount or
    types of food at screening
    - 1 or 2 naïve or anastomotic stenoses in the terminal ileum at
    screening, confirmed by MRE at randomization
    - Have achieved Symptomatic Stenosis Response before randomization
    (i.e. 7 day average scores <2 for diary questions on the abdominal pain
    after eating AND on the limitation in amount or types of food)
    - Endoscopic activity defined by Colonic Simple Endoscopic Score in CD
    (SES-CD) =12 after Lead-in Period, at the time of randomization
    -Paziente di età compresa tra i 18 (maggiore età in base alla legislazione locale) e i 75 anni al momento della firma del consenso informato
    -Pazienti che abbiano datato e firmato il consenso informato secondo i principi di Buona pratica clinica (BPC) e la legislazione locale prima dell’ammissione nello studio
    -Diagnosi confermata di malattia di Crohn da prima dello screening
    -Sospetto di stenosi sintomatica dell'intestino tenue
    -Presenza alla visita di screening (o almeno 7 giorni prima) di dolore addominale dopo i pasti (spesso, ogni volta, non mangiare a causa dei sintomi del mio Crohn) o riduzione della quantità o dei tipi di alimenti (moderata o forte), valutati dallo sperimentatore con il paziente per mezzo dei due elementi utilizzati per definire la risposta e la ricaduta della stenosi sintomatica
    -1 o 2 stenosi non anastomotiche o anastomotiche nell’ileo terminale (evidenziate da ecografia intestinale, TC, enterografia TC, RM o enterografia RM)
    -Hanno ottenuto una risposta alla stenosi sintomatica (punteggi medi <2 per domande sul dolore addominale dopo aver mangiato E sulla limitazione della quantità o dei tipi di cibo) durante i 7 giorni dopo la terapia antinfiammatoria biologica ottimizzata prima della randomizzazione (vedi Diagramma di flusso 2).
    -Attività endoscopia assente, lieve o moderata definita da un punteggio SES-CD (Simple Endoscopic Score in Crohn’s Disease) del colon =12
    Per gli altri criteri vedere la sinossi in italiano
    E.4Principal exclusion criteria
    - No stenosis in reach of ileocolonoscopy
    - Systemic corticosteroid treatment of current obstructive symptoms for >1 week prior to screening
    - Endoscopic balloon dilation (EBD) or surgical treatment of the same
    small bowel stenosis within the last 6 months prior to screening Visit 1
    - More than 2 smal intestinal stenoses
    - Patients who require immediate EBD or surgical intervention as per the
    investigator´s discretion
    - Failure of >2 different biological drug classes prior to screening (e.g.
    TNF inhibitors, Integrin Receptor antagonists and
    IL-12 / IL-23 antagonists)
    - Current complications of CD at screening Visit 1 and randomization
    (Day 1) that would possibly confound the evaluation of benefit from
    treatment with spesolimab
    - Current stenosis in the colon
    - Previous strictureplasty on current stricture
    - Current ileostomy or colostomy
    - Any kind of bowel resection or diversion within 6 months of screening
    Visit 1
    - Any other intra-abdominal surgery (except for abscess drainage)
    within 3 months prior to screening Visit
    - Colorectal cancer (CRC) present and past (<5 years) history
    Criteri di esclusione gastrointestinali
    1. Nessuna stenosi a portata dell’ileocolonscopia
    2. Trattamento sistemico con corticosteroidi dei sintomi ostruttivi in corso per più di 1 settimana prima dello screening
    3. Dilatazione endoscopica con palloncino o trattamento chirurgico della stessa stenosi dell’intestino tenue nei 6 mesi precedenti la Visita 1 di screening
    4. Più di 2 stenosi dell’intestino tenue (2 stenosi entro 3 cm sono considerate come la stessa stenosi; un segmento lungo con più aree di restringimento o più stenosi alternate ad aree di infiammazione è conteggiato come 1 stenosi)
    5. Pazienti che necessitano immediatamente di una dilatazione endoscopica con palloncino o di un intervento chirurgico, secondo il giudizio dello sperimentatore
    6. Fallimento della terapia con >2 diverse classi di farmaci biologici (meccanismi d’azione) prima dello screening (ad es. inibitori del TNF, antagonisti delle integrine e antagonisti di IL-12/IL-23)
    7. Pazienti che devono o desiderano continuare l’assunzione di medicinali soggetti a limitazioni o di qualsiasi medicinale che si ritiene possa interferire con la conduzione sicura della sperimentazione
    8. Presenza di complicanze della malattia di Crohn, quali fistole enterocutanee, interne o rettovaginali, sindrome dell’intestino corto, ascesso o qualsiasi altra manifestazione che potrebbe richiedere un intervento chirurgico o potrebbe confondere la valutazione del beneficio derivante dal trattamento con spesolimab alla Visita di screening 1 e alla randomizzazione (Giorno 1)
    9. Presenza di stenosi del colon Stenosi (si applicano i criteri di CONSTRICT)
    10. Stricturoplastica precedente su stenosi attuale
    11. Presenza di ileostomia o colostomia
    12. Qualsiasi tipo di resezione o deviazione intestinale nei 6 mesi precedenti la Visita 1 di screening
    13. Qualsiasi altro intervento chirurgico intraddominale (eccetto il drenaggio di ascessi) nei 3 mesi precedenti la Visita 1 di screening
    14. Esame delle feci positivo per Clostridium difficile o qualsiasi altro agente patogeno intestinale <30 giorni prima dello screening
    15. Trapianto fecale =6 mesi prima dello screening
    Per gli altri criteri vedere la sinossi in italiano
    E.5 End points
    E.5.1Primary end point(s)
    1) Proportion of patients with maintained Symptomatic Stenosis
    2) Proportion of patients with Radiographic Stenosis Response
    Endpoint primari. Superiorità di spesolimab vs placebo relativamente a uno dei seguenti aspetti:
    1) Percentuale di pazienti che hanno mantenuto la risposta in termini di stenosi sintomatica alla Settimana 48
    2) Percentuale di pazienti con risposta in termini di stenosi radiografica alla Settimana 48
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Week 48
    2) Week 48
    1) settimana 48
    2) settimana 48
    E.5.2Secondary end point(s)
    1) Proportion of patients with maintained Symptomatic Stenosis
    2) Proportion of patients with Radiographic Stenosis Response
    1) Percentuale di pazienti che hanno mantenuto la risposta in termini di stenosi sintomatica alla Settimana 24
    2) Percentuale di pazienti con risposta in termini di stenosi radiografica alla Settimana 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Week 24
    2) Week 24
    1) settimana 24
    2) settimana 24
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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. 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Hong Kong
    Korea, Republic of
    United States
    United Kingdom
    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
    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 months6
    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 months9
    E.8.9.2In all countries concerned by the trial days3
    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: 80
    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 66
    F.4.2.2In the whole clinical trial 100
    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)
    Extension trial for patients, who have an individual benefit from study
    drug. All others: Standard of care according to investigator
    Studio di estensione per i pazienti che hanno un beneficio individuale dallo studio
    droga. Tutti gli altri: Standard di cura secondo lo sperimentatore
    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 Decision2021-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-05-13
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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
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