E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with moderately to severely active Crohn's disease |
Soggetti affetti da malattia di Crohn attiva di grado moderato-grave |
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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] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011401 |
E.1.2 | Term | Crohn's disease |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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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 primary objective of the study is to assess the efficacy, safety, and tolerability of ABBV 154 in comparison with placebo in subjects with moderately to severely active CD who had inadequate response to or were intolerant of prior biologics. |
L’obiettivo primario dello studio è quello di valutare l’efficacia, sicurezza e tollerabilità di ABBV-154 rispetto a placebo in soggetti affetti da malattia di Crohn in fase attiva di grado da moderato a grave che abbiano presentato una risposta inadeguata o intolleranza a biologici pregressi. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ABBV 154. |
Gli obiettivi secondari sono valutare la farmacocinetica (PK), farmacodinamica (PD) e immunogenicità di ABBV-154. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female between 18 and 75 years of age inclusive at the time of Screening. 2. Confirmed diagnosis of CD for at least 3 months prior to Baseline of the Induction Period. 3. CDAI score 220 to 450 at Baseline of the Induction Period. 4. Endoscopic evidence of mucosal inflammation as documented by an SES-CD of = 6 for ileocolonic or colonic disease or SES-CD of = 4 for isolated ileal disease as scored by a central reader. All eligible scores must exclude the presence of narrowing component. 5. Demonstrated intolerance or inadequate response to one or more of the following biologic agents: infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab, or ustekinumab.
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1. Soggetti di ambo i sessi di età compresa fra 18 e 75 anni, compresi, al momento dello Screening. 2. Diagnosi confermata di malattia di Crohn da almeno 3 mesi prima del Baseline del Periodo di Induzione. 3. Punteggio CDAI compreso fra 220 e 450 al Baseline del Periodo di Induzione. 4. Evidenza endoscopica di infiammazione della mucosa, documentato da punteggio SES-CD = 6 per malattia ileocolica o colica oppure da punteggio SES-CD = 4 per la malattia ileale isolata sulla base del punteggio assegnato da lettore centrale. Tutti i punteggi eleggibili devono escludere la presenza della componente relativa al restringimento . 5. Evidenza di intolleranza o risposta inadeguata a uno o più fra i seguenti agenti biologici: infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab o ustekinumab. |
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E.4 | Principal exclusion criteria |
1. Subjects with prior intolerance to adalimumab are not eligible to enroll. 2. Subjects who discontinued biologic agents only for reasons other than inadequate response or intolerance (e.g., change of insurance) are not eligible to enroll. |
1. Non sono eleggibili ad essere arruolati i soggetti con pregressa intolleranza ad adalimumab. 2. Non sono eleggibili ad essere arruolati i soggetti che hanno interrotto agenti biologici esclusivamente per motivi diversi dalla risposta inadeguata o intolleranza (es cambiamenti nella rimborsabilità ) |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the achievement of endoscopic response at Week 12 in the Induction Period defined as a decrease in Simple Endoscopic Score for Crohn’s Disease (SES-CD17) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline). |
L’endpoint primario è rappresentato dall’ottenimento di risposta endoscopica alla Settimana 12 nel corso del Periodo di Induzione, definita quale riduzione rispetto al Baseline > 50% del punteggio Simple Endoscopic Score for Crohn's Disease (SES-CD17) (oppure per i soggetti con malattia ileale isolata e un punteggio SES-CD pari a 4 al Baseline, una riduzione di almeno 2 punti rispetto al Baseline). |
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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) |
• Achievement of clinical remission per Crohn’s Disease Activity Index (CDAI) at Week 12 in the Induction Period defined as CDAI < 150. • Achievement of clinical remission per average daily liquid or very soft stool frequency (SF) and average daily abdominal pain (AP) score (SF/AP) at Week 12 in the Induction Period defined as average daily liquid or very soft SF = 2.8 and not worse than Baseline AND average daily AP score = 1 and not worse than Baseline. • Achievement of endoscopic response per SES-CD at Week 40 in the Maintenance Period. • Achievement of clinical remission per CDAI at Week 40 in the Maintenance Period. • Achievement of clinical remission per SF/AP at Week 40 in the Maintenance Period.
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• Ottenimento della remissione clinica sulla base del punteggio CDAI (Crohn's Disease Activity Index) alla Settimana 12 nel Periodo di Induzione, definita quale punteggio CDAI < 150 • Ottenimento della remissione clinica sulla base della frequenza media giornaliera delle evacuazioni (stool frequency, SF) di feci liquide o molto molli e del punteggio medio giornaliero relativo al dolore addominale (abdominal pain, AP) (SF/AP) alla Settimana 12 del Periodo di Induzione, definita quale media giornaliera di SF di feci liquide o molto molli = 2,8 e non peggiore rispetto al Baseline IN AGGIUNTA A punteggio medio giornaliero di AP = 1 e non peggiore rispetto al Baseline • Ottenimento della risposta endoscopica sulla base del punteggio SES_CD alla Settimana 40 nel corso del Periodo di Mantenimento • Ottenimento della remissione clinica sulla base del punteggio CDAI alla Settimana 40 nel corso del Periodo di Mantenimento • Ottenimento della remissione clinica sulla base del punteggio SF/AP alla Settimana 40 nel corso del Periodo di Mantenimento |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 12 and Week 40 |
Settimana 12 e Settimana 40 |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Also assess Immunogenicity of ABBV-154 |
Valutare anche l'immunogenicità di ABBV-154 |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
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 | 5 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 51 |
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 |
Canada |
Israel |
Japan |
Korea, Republic of |
New Zealand |
Russian Federation |
Taiwan |
United States |
Austria |
Belgium |
Bulgaria |
France |
Germany |
Italy |
Netherlands |
Poland |
Slovakia |
Spain |
United Kingdom |
Czechia |
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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The end-of-study is defined as 70 days after the last study drug administration. |
Per fine dello studio si intende la tempistica di 70 giorni dopo l’ultima somministrazione del medicinale sperimentale |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 41 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 41 |
E.8.9.2 | In all countries concerned by the trial days | 0 |