E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Crohns disease |
enfermedad de Crohn |
|
E.1.1.1 | Medical condition in easily understood language |
Crohns disease |
enfermedad de Crohn |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
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 | 10011408 |
E.1.2 | Term | Crohns disease aggravated |
E.1.2 | System Organ Class | 100000004856 |
|
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 |
To evaluate the long-term safety of spesolimab in patients with perianal fistulising Crohn’s disease who have completed treatment in parent trials |
Evaluar la seguridad a largo plazo de spesolimab en pacientes con enfermedad de Crohn fistulizante que completaron el tratamiento en ensayos anteriores. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the long-term efficacy of spesolimab in patients with perianal fistulising Crohn’s disease, who have completed treatment in parent trials |
Evaluar la eficacia a largo plazo de spesolimab en pacientes con enfermedad de Crohn fistulizante que completaron el tratamiento en ensayos anteriores. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patient older than 18 years - Has completed all treatments (placebo or active treatment) and the EOT visit in the parent induction trial in fistulising CD and is willing and able to continue treatment in 1368-0007. - Has obtained an individual health benefit, per investigator judgement (such as fistula response or remission or other clinical improvement), from treatment in the parent trial. - Signed and dated written informed consent for 1368-0007 in accordance with GCP and local legislation prior to admission into the trial. - Women of childbearing potential (WOCBP) must be ready to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. |
- Paciente mayor de 18 años. - Ha completado todos los tratamientos asignados y la visita de FdT en el ensayo de inducción anterior en la EC fistulizante y está dispuesto a continuar el tratamiento en el ensayo 1368-0007 y es capaz de hacerlo. - Ha obtenido un beneficio individual para su salud, según el criterio del investigador (como respuesta o remisión de la fístula u otra mejoría clínica), con el tratamiento en el ensayo principal. • Ha firmado y fechado el consentimiento informado por escrito para 1368-0007, de conformidad con las normas de BPC y la legislación local antes de la inclusión en el estudio. - Las mujeres con posibilidad de quedarse embarazadas deben estar dispuestas a usar métodos anticonceptivos de elevada eficacia según la directriz M3 (R2) del ICH. En la información para el paciente se puede ver una lista de los métodos anticonceptivos que siguen este criterio. |
|
E.4 | Principal exclusion criteria |
- Have experienced treatment-limiting adverse events during induction treatment with study drug. - Have developed any condition which meets the exclusion criteria from the original induction study. - Any condition which in the opinion of the investigator affects the safety or ability to participate in this trial. |
- No haber presentado acontecimientos adversos limitantes del tratamiento durante el tratamiento de inducción con el fármaco del estudio. - No haber presentado ninguno de los criterios de exclusión del estudio de inducción original. - Cualquier circunstancia que, en opinión del investigador, afecte a la seguridad o la capacidad para participar en este ensayo. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1) Exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE) |
1) Tasa de pacientes con acontecimientos adversos (AA) surgidos durante el tratamiento, ajustada por la exposición |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1) Up to week 336 |
1) Hasta la semana 336 |
|
E.5.2 | Secondary end point(s) |
1) Proportion of patients with perianal fistula remission 2) Proportion of patients with perianal fistula response |
1) Proporción de pacientes con remisión de la fístula perianal. 2) Proporción de pacientes con respuesta de la fístula perianal. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Weeks 48, 96, 144, 192, 240, 288, and 336 2) Week 48, 96, 144, 192, 240, 288, and 336 |
1) Semanas 48, 96, 144, 192, 240, 288, y 336 2) Semanas 48, 96, 144, 192, 240, 288, y 336 |
|
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 | 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) | 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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
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 |
Korea, Republic of |
Austria |
Belgium |
Denmark |
Germany |
Hungary |
Netherlands |
Spain |
|
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
|
LVLS |
Última visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |