E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Crohn's Disease |
Malattia di Crohn |
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E.1.1.1 | Medical condition in easily understood language |
Crohn's Disease |
Malattia di Crohn |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013099 |
E.1.2 | Term | Disease Crohns |
E.1.2 | System Organ Class | 100000004856 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of Study M16-006 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD. |
L¿obiettivo della Sperimentazione M16-006 ¿ quello di valutare l¿efficacia e la sicurezza di risankizumab rispetto a placebo durante la terapia di induzione in soggetti affetti da malattia di Crohn in fase attiva di grado da moderato a grave. |
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E.2.2 | Secondary objectives of the trial |
Not applicable |
non applicabile |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit - Diagnosis of CD for at least 3 months prior to Baseline -Crohn's disease activity index (CDAI) score 220-450 at Baseline - Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD) - Demonstrated intolerance or inadequate response to conventional or biologic therapy for CD - If female, subject must meet the contraception recommendations. |
1. Soggetti di ambo i sessi di età compresa fra = 18 e = 80 anni alla visita di Baseline. Ove permesso, soggetti di età pari a 16 e < 18 anni il cui sviluppo è classificato come stadio 5 secondo Tanner alla visita di Baseline. 2. Diagnosi di malattia di Crohn da almeno 3 mesi prima del Baseline 3. indice di attività della malattia di Crohn (CDAI) al valore di Baseline 220-450 4. Diagnosi confermata di malattia di Crohn da severa a moderata valutata dalla frequenza di evacuazione (SF), scala del dolore addominale (AP) e il SES-CD (Simple endoscopic score) per la malattia di Crohn 5. Dimostrata intolleranza o risposta inadeguata alla terapia convenzionale o biologica per la Malattia di Crohn. 6. se donna, il soggetto deve seguire le raccomandazioni in merito alla contraccezione |
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E.4 | Principal exclusion criteria |
- Subject with a current diagnosis of ulcerative colitis or indeterminate colitis - Subjects with unstable doses of concomitant Crohn's disease therapy - Receipt of Crohn's disease approved biologic agents (within 8 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days prior to the Baseline - Prior exposure to p40 inhibitors (e.g., ustekinumab [Stelara]) or p19 inhibitors (e.g., risankizumab) - Complications of Crohn's disease (strictures, stenosis, short bowel, etc) - Having an ostomy or ileoanal pouch |
1. Soggetto con diagnosi attuale di colite ulcerosa oppure colite di natura indeterminata 2. Soggetti in trattamento con dosi instabili della terapia concomitante di malattia di Crohn 3. ricezione di agenti biologici approvati dalla malattia di Crohn (entro 8 settimane prima della linea di base) o qualsiasi altro agente o procedura biologica di ricerca entro 35 giorni prima della linea di base 4. esposizione precedente ad inibitori p40 (ad esempio, ustekinumab [Stelara]) o inibitori p19 (ad esempio, risanzumab) 5. Complicanze della malattia di Crohn (stenosi, stenosi, intestino corto, ecc) 6. sacca ostomica o ileoanale |
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E.5 End points |
E.5.1 | Primary end point(s) |
Co-Primary Endpoints: Proportion of participants with clinical remission (per daily stool frequency [SF] and average daily abdominal pain [AP] score) at Week 12 and percentage of participants with endoscopic response at Week 12 |
Co-endpoints Primari: percentuale di pazienti con remissione clinica (per la frequenza giornaliera di evacuazione [SF] e il punteggio medio giornaliero del dolore addominale [AP]) alla settimana 12 e la percentuale di partecipanti con risposta endoscopica alla settimana 12 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Proportion of participants with enhanced clinical response at Week 4, defined as decrease in average daily SF and/or decrease in average daily AP score and/or clinical remission per average daily SF and average daily AP score 2. Proportion of participants with clinical remission per Crohn's disease activity index (CDAI) at Week 12 3. Proportion of participants with enhanced clinical response at Week 12, defined as defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score 4. Proportion of participants with clinical remission per average daily SF and average daily AP score at Week 4 5. Proportion of participants with enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score and endoscopic response defined as decrease from Baseline in SES-CD at Week 12 6. Proportionof participants with endoscopic healing, assessed using SES-CD, at Week 12 7. Crohn's Symptom Severity (CSS): Change from Baseline to Week 12 8. Proportion of subjects with Endoscopic remission at Week 12 9. Proportion of participants with resolution of extra-intestinal manifestations (EIMs) at Week 12, in subjects with EIMs at Baseline 10. Proportion of participants with hospitalization through Week 12 11. Proportion of participants with draining fistulas at Week 12 in participants with draining fistulas at Baseline 12. Functional Assessment of Chronic Illness Therapy-Fatigue (FACITFatigue): Change from Baseline to Week 12 13. 36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12 14. Percentage of participants with Crohn's disease (CD)-related surgeries through Week 12 |
1. Percentuale di soggetti con risposta clinica incrementata alla Settimana 4, definita come diminuzione della media giornaliera SF e / o diminuzione del media giornaliera del valore di AP e / o la remissione clinica per media giornaliera del valore di SF e AP. 2. Percentuale di soggetti con remissione clinica per indice di attivit¿ della malattia di Crohn (CDAI) alla settimana 12 3. Percentuale di soggetti con risposta clinica incrementata alla Settimana 12, definata come diminuzione della media giornaliera SF e/o diminuizione della media giornaliera del valore di AP, e/o remissione clinica per media giornaliera del valore di SF e AP. 4. Percentuale di soggetti con remissione clinica alla Settimana 4 con media giornaliera del valore di SF e AP 5. Percentuale di soggetti con risposta clinica incrementata, definita come diminuizione della media giornaliera di SF e/o diminuizione della media giornaliera del valore di AP, e risposta endoscopica definita come diminuizione rispetto al Baseline nel SES-CD alla Settimana 12. 6. Percentuale di soggetti con guarigione endoscopica valutato utilizzando SES-CD alla Settimana 12. 7. Variazione rispetto al Baseline del Crohn¿s Symptom Severity punteggio (CSS) (Crohn¿s Symptom Severity) alla Settimana 12. 8. Percentuale di soggetti con remissione endoscopica alla settimana 12 9. Percentuale di soggetti con risoluzione delle manifestazioni extra-intestinali (extra-intestinal manifestations, EIM) alla Settimana 12, nei soggetti che presentavano EIM al Baseline. 10. Percentuale di soggetti con ricovero ospedaliero fino alla Settimana 12 compresa . 11. Percentuale di soggetti con fistole secernenti alla Settimana 12 nei soggetti che presentavano fistole secernenti al Baseline. 12. Variazione rispetto al Baseline del punteggio FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue (FACITFatigue) alla Settimana 12. 13. Variazione rispetto al Baseline del punteggionello Short Form-36 alla Settimana 12. 14. Percentuale di soggetti sottoposti a interventi chirurgici associati alla malattia di Crohn fino alla Settimana 12 compresa. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Week 4 2. Week 12 3. Week 12 4. Week 4 5. Week 12 6. Week 12 7. Week 12 8. Week 12 9. Week 12 10. Week 12 11. Week 12 12. Week 12 13. Week 12 14. Week 12 |
1. settimana 4 2. settimana 12 3. settimana 12 4. settimana 4 5. settimana 12 6. settimana 12 7. settimana 12 8. settimana 12 9. settimana 12 10. settimana 12 11. settimana 12 12. settimana 12 13. settimana 12 14. settimana 12 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 6 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 13 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 162 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Belarus |
Bosnia and Herzegovina |
Brazil |
Canada |
Chile |
Colombia |
Egypt |
Hong Kong |
Israel |
Japan |
Korea, Democratic People's Republic of |
Malaysia |
Mexico |
New Zealand |
Puerto Rico |
Russian Federation |
Serbia |
Singapore |
South Africa |
Taiwan |
Turkey |
Ukraine |
United States |
Austria |
Belgium |
Bulgaria |
Croatia |
Denmark |
Estonia |
Finland |
France |
Germany |
Ireland |
Italy |
Latvia |
Lithuania |
Netherlands |
Norway |
Poland |
Portugal |
Romania |
Slovakia |
Slovenia |
Spain |
Sweden |
Switzerland |
United Kingdom |
Czechia |
Argentina |
Greece |
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E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 2 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 2 |