E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Crohn's Disease |
Enfermedad de Crohn |
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E.1.1.1 | Medical condition in easily understood language |
Crohn's Disease |
Enfermedad de Cronh |
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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. |
El objetivo del estudio M16-006 es evaluar la eficacia y seguridad de risankizumab versus placebo durante la terapia de inducción en sujetos con enfermedad de Crohn de moderada a activa |
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E.2.2 | Secondary objectives of the trial |
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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 |
-Varón o mujer >= 18 años <= 80 años en el momento de la visita basal. Donde sea localmente permitido, sujetos de 16 a <18 años de edad que cumplan con el estadío 5 de desarrollo según la definición de Tanner en la visita basal -Diagnóstico de Enfermedad de Crohn al menos 3 meses antes de la visita basal - Puntuación 220-450 en Índice de actividad de la enfermedad de Crohn (CDAI) en la visita basal -Diagnóstico confirmado de enfermedad de Crohn de moderada a grave según la frecuencia de heces (SF), el puntaje de dolor abdominal (AP) y la puntuación endoscópica simple para la enfermedad de Crohn (SES-CD) - Intolerancia demostrada o respuesta inadecuada a terapia convencional o biológica para enfermedad de Crohn - Si es mujer, debe cumplir con las recomendaciones de anticoncepción |
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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 |
-Sujeto con un diagnóstico actual de colitis ulcerosa o colitis indeterminada -Sujetos con dosis inestables de terapia concomitante para la enfermedad de Crohn -Haber recibido agentes biológicos aprobados para la enfermedad de Crohn (dentro de las 8 semanas anteriores a la visita basal), o cualquier agente biológico u otro agente de investigación en un mínimo de 35 días antes de la visita basal - Exposición previa a inhibidores p40 (por ejemplo, ustekinumab [Stelara]) o inhibidores p19 (por ejemplo, risankizumab) -Complicaciones de la enfermedad de Crohn (estenosis, intestino corto, etc.) Tener bolsa de ostomía o ileoanal |
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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 |
Criterios de valoración co-primarios:
-Proporción de participantes con remisión clínica (por frecuencia diaria de heces [SF] y puntuación promedio de dolor abdominal diario [AP]) en la semana 12 y porcentaje de participantes con respuesta endoscópica en la semana 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 participants with resolution of extra-intestinal manifestations (EIMs) at Week 12, in subjects with EIMs at Baseline 9. Proportion of participants with hospitalization through Week 12 10. Proportion of participants with draining fistulas at Week 12 in participants with draining fistulas at Baseline 11. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12 12. 36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12 13. Percentage of participants with Crohn's disease (CD)-related surgeries through Week 12 |
1. Proporción de participantes con respuesta clínica mejorada en la semana 4, definida como disminución en la frecuencia de heces media diaria y / o disminución en la puntuación media AP y / o remisión clínica medida por promedio diario de frecuencia de heces y la puntuación media de AP 2. Proporción de participantes con remisión clínica por índice de actividad de la enfermedad de Crohn (CDAI) en la semana 12 3. Proporción de participantes con respuesta clínica mejorada en la semana 12, definida como disminución en la frecuencia de heces diaria promedio y / o disminución en la puntuación media AP y / o remisión clínica por frecuencia de heces promedia diaria y puntuación AP media diaria 4. Proporción de participantes con remisión clínica por frecuencia de heces promedio diaria y puntuación promedio AP en la semana 4 5. Proporción de participantes con respuesta clínica mejorada definida como disminución en la frecuencia de heces promedia diaria y / o disminución en la puntuación media AP y respuesta endoscópica definida como disminución en SES-CD en la semana 12 comparada con la visita basal 6. Proporción de participantes con curación endoscópica, evaluada mediante SES-CD, en la semana 12 7. Gravedad de los síntomas de Crohn (CSS): Cambios desde la visita basal en la semana 12 8. Proporción de participantes con resolución de manifestaciones extraintestinales (EIM) en la semana 12, en sujetos con EIMs en la visita basal 9. Proporción de participantes que han sido hospitalizados hasta la semana 12 10. Proporción de participantes con fístulas de drenaje en la Semana 12 comparada con los participantes con fístulas de drenaje en la visita basal 11. Evaluación Funcional para el Tratamiento de Enfermedades Crónicas - Fatiga (FACIT-Fatiga): Cambios entre la visita basal y la Semana 12 12. Encuesta sobre el estado de salud de 36 elementos (SF-36): Cambios entre la visita basal y la Semana 12 13. Porcentaje de participantes con cirugías relacionadas con la enfermedad de Crohn (CD) hasta la semana 12 |
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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. 12 weeks 10. Week 12 11. Baseline, Week 12 12. Baseline, Week 12 13. 12 weeks |
1. Semana 4 2. Semana 12 3. Semana 12 4. Semana 4 5. Semana 12 6. Semana 12 7. Semana 12 8. Semana 12 9. 12 Semanas 10. Semana 12 11. Baseline, Semana 12 12. Baseline, Semana 12 13. 12 Semanas |
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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
| Yes |
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 | 10 |
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 | No |
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 |
Australia |
Austria |
Belarus |
Belgium |
Bosnia and Herzegovina |
Brazil |
Bulgaria |
Canada |
Chile |
Colombia |
Croatia |
Czech Republic |
Denmark |
Egypt |
Estonia |
Finland |
France |
Germany |
Greece |
Hong Kong |
Hungary |
Ireland |
Israel |
Italy |
Japan |
Korea, Republic of |
Latvia |
Lithuania |
Malaysia |
Mexico |
Netherlands |
New Zealand |
Norway |
Poland |
Portugal |
Puerto Rico |
Romania |
Russian Federation |
Serbia |
Singapore |
Slovakia |
Slovenia |
South Africa |
Spain |
Sweden |
Switzerland |
Taiwan |
Turkey |
Ukraine |
United Kingdom |
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 | 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 |