E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of moderately to severely active Crohn’s disease with JNJ-67864238. |
Trattamento della malattia di Crohn attiva di grado da moderato a severo con JNJ-67864238. |
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E.1.1.1 | Medical condition in easily understood language |
Treatment of moderately to severely active Crohn’s disease with JNJ-67864238. |
Partecipanti affetti da malattia di Crohn attiva di grado da moderato a severo |
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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 | 10021425 |
E.1.2 | Term | Immune system disorder |
E.1.2 | System Organ Class | 10021428 - Immune system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10021428 |
E.1.2 | Term | Immune system disorders |
E.1.2 | System Organ Class | 10021428 - Immune system 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 is to evaluate the efficacy of JNJ-67864238 as measured by the change in the Crohn’s Disease Activity Index (CDAI) score and Simplified Endoscopic Score for Crohn’s disease (SES-CD) from baseline at Week 12. |
L’obiettivo primario è valutare l’efficacia di JNJ-principio attivo così come misurato dalla variazione del punteggio dell’indice di attività della malattia di Crohn (CDAI) dal basale alla Settimana 12. |
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E.2.2 | Secondary objectives of the trial |
To investigate the safety and tolerability of JNJ-67864238 in participants with moderately to severely active Crohn’s disease. To evaluate the efficacy of JNJ-67864238 to induce clinical remission, clinical response, and endoscopic healing of the mucosa. To evaluate the pharmacokinetics, pharmacodynamics, immunogenicity, and biomarker response of JNJ-67864238. |
I principali obiettivi secondari sono i seguenti: • Indagare la sicurezza e la tollerabilità di JNJ-principio attivo nei partecipanti affetti da malattia di Crohn attiva di grado da moderato a severo. • Valutare l’efficacia di JNJ-principio attivo al fine di ridurre il punteggio endoscopico semplice per la Malattia di Crohn (SES-CD), indurre la remissione clinica, la risposta clinica e la guarigione endoscopica della mucosa. • Valutare farmacocinetica, farmacodinamica, immunogenicità e la risposta dei biomarcatori di JNJ-principio attivo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female 2. 18 to 75 years of age, inclusive Disease Characteristics 3. Have Crohn’s disease or fistulizing Crohn’s disease of at least 3 months’ duration, with colitis, ileitis, or ileocolitis confirmed at any time in the past by radiography, histology, and/or endoscopy 4. Have active Crohn’s disease, defined as a baseline CDAI score of major or equal to 220 and minor or equal 450 5. Have evidence of active ileocolonic Crohn’s disease as assessed by: a. An SES-CD score major or equal to 3 at screening by central endoscopy reading OR b. An elevated screening CRP (>0.3 mg/dL or 3.0 mg/L) or an elevated screening fecal calprotectin (>250 ug/mg) |
1. Sesso maschile o femminile 2. Età compresa tra 18 e 75 anni, inclusi 3. Malattia di Crohn o malattia di Crohn fistolizzante che si protrae da almeno 3 mesi con colite, ileite o ileocolite, confermata in precedenza da radiografia, esame istologico e/o endoscopia 4. Malattia di Crohn attiva, definita come punteggio CDAI al basale maggiore o uguale a 220 e inferiore o uguale a 450 5. Evidenza di malattia di Crohn ileocolica attiva valutata come indicato di seguito: a. Punteggio SES-CD maggiore o uguale a 3 allo screening stabilito con lettura centrale endoscopica. OPPURE b. Un livello elevato di CRP (>0,3 mg/dL o 3,0 mg/L) allo screening o un livello elevato di calprotectina fecale (>250 µg /mg) allo screening |
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E.4 | Principal exclusion criteria |
1.Has complications of Crohn’s disease such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with JNJ-67864238 2.Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. Participants with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified 3. Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months before baseline 4. Has a draining (ie, functioning) stoma or ostomy 5. Has received any of the following prescribed medications or therapies within the specified period: Compound a. Intravenous corticosteroids - Exclusionary Period <3 weeks before baseline b. Oral immunomodulatory agents including 6-thioguanine (6-TG), cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil, tofacitinib and other Janus kinase (JAK) inhibitors - Exclusionary Period <6 weeks or within 5 half-lives of agent before baseline, whichever is longer c. Natalizumab or biologic agents that deplete B or T cells (eg, rituximab or alemtuzumab) - Exclusionary Period <12 weeks before baseline |
1. Complicazioni di malattia di Crohn quali tratti ristretti o stenosi sintomatici, sindrome dell'intestino corto o qualsiasi altra manifestazione che potrebbe lasciar supporre la necessità di un intervento chirurgico, precludere l'utilizzo dell'Indice di attività della malattia di Crohn per la valutazione della risposta alla terapia o confondere potenzialmente la capacità di valutazione dell'effetto del trattamento con JNJ-principio attivo 2. Ascesso sospetto o in corso. Ascessi cutanei e perianali recenti non costituiscono criterio di esclusione se drenati e adeguatamente trattati almeno 3 settimane prima del basale, o 8 settimane prima del basale nel caso di ascessi intra-addominali, purché non si supponga la necessità di ulteriori interventi chirurgici. I partecipanti con fistole attive possono essere inclusi qualora non si ipotizzi alcuna necessità di intervenire chirurgicamente e non siano stati identificati ascessi in corso 3. Qualsiasi tipo di resezione intestinale avvenuta entro i 6 mesi precedenti al basale o altro intervento intra-addominale entro i 3 mesi precedenti al basale. 4. Presenza di stoma o ostomia drenante (ad es., funzionante) 5. Precedente somministrazione di qualsiasi dei seguenti farmaci o terapie prescritti entro il periodo specificato: Composto a. Corticosteroidi per via endovenosa - Periodo di esclusione <3 settimane prima del basale b. Agenti immunomodulatori per via orale compresa 6-tioguanina (6-TG), ciclosporina, tacrolimus, sirolimus o mofetil micofenolato, tofacitinib e agli inibitori della Janus chinasi (JAK) - Periodo di esclusione <6 settimane o entro le 5 semivite di un agente precedentemente al basale, a seconda di quale sia il periodo più lungo c. Natalizumab o agenti biologici che riducono le cellule B o T (ad es. rituximab o alemtuzumab) Periodo di esclusione <12 settimane prima del basale |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the change from baseline in the CDAI score at Week 12. |
L’endpoint primario è la variazione dal basale del punteggio CDAI 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. Change in the SES-CD from baseline 2. Clinical response as measured by CDAI (=100-point reduction from baseline in CDAI or CDAI <150) 3. Clinical remission rate as measured by CDAI (CDAI <150) 4. PRO-2 remission defined as abdominal pain (AP) mean daily score (AP component of the CDAI) at or below 1 AND stool frequency (SF) mean daily score at or below 3, ie, AP =1 and SF =3 5. Endoscopic response defined as at least a 50% improvement from baseline in the SES-CD 6. Endoscopic remission defined as an SES-CD score =2 |
I principali endpoint secondari includono le seguenti misurazioni alla Settimana 12: 1. Variazione del SES-CD dal basale 2. Risposta clinica misurata dal CDAI (riduzione di = 100 punti dal basale in CDAI o CDAI <150) 3. Tasso di remissione clinica misurata secondo CDAI (CDAI <150) 4. Remissione per esito riferito dal paziente (PRO)-2 definita come punteggio medio giornaliero (componente AP del CDAI) del dolore addominale (AP) pari o inferiore a 1 E punteggio medio giornaliero di frequenza di evacuazione (SF) pari o inferiore a 3, ossia AP =1 e SF = 3 5. Risposta endoscopica definita come un aumento di almeno il 50% del SES-CD dal basale 6. Remissione endoscopica definita come punteggio SES-CD = 2 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
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) | 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 | 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 | 2 |
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 | 14 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 34 |
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 |
Argentina |
Germany |
Italy |
Poland |
Russian Federation |
United States |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |