E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hidradenitis Suppurativa |
Hidradenitis Supurativa |
|
E.1.1.1 | Medical condition in easily understood language |
Hidradenitis Suppurativa |
Hidradenitis Supurativa |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
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 | 10020041 |
E.1.2 | Term | Hidradenitis suppurativa |
E.1.2 | System Organ Class | 100000004858 |
|
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 this trial is to assess the long-term safety of spesolimab in patients with HS who have completed the 1368-0052 PoCC trial and are qualified for entry into this trial. |
El objetivo principal de este ensayo es evaluar la seguridad a largo plazo de spesolimab en pacientes con HS que han completado el ensayo 1368-0052 PoCC y están calificados para participar en este ensayo. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives are to evaluate efficacy at a lower dose than tested in PoCC trial. |
Los objetivos secundarios son evaluar la eficacia a una dosis más baja que la analizada en el ensayo PoCC. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients who have completed treatment in the parent HS spesolimab trial (1368-0052) without premature discontinuation. |
- Pacientes que completaron el tratamiento en el ensayo original de HS con spesolimab (1368-0052) sin una interrupción prematura. |
|
E.4 | Principal exclusion criteria |
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial. - Patients who experienced study treatment-limiting adverse events during the 1368-0052 parent trial. - Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof. - Any condition which in the opinion of the investigator affects the safety of the patient, the patient’s ability to participate in this trial or could compromise the quality of data. - Any suicidal behaviour in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour). - Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months (i.e. active suicidal thoughts with method and intent but without specific plan, or active suicidal thoughts with method, intent and plan). |
- Mujeres embarazados, en lactancia o que planeen quedarse embarazadas durante el estudio. - Pacientes que experimentaron acontecimientos adversos limitantes del tratamiento del ensayo durante el ensayo principal 1368-0052. - Enfermedades graves, progresivas o no controladas, tales como enfermedad renal, hepática, hematológica, endocrina, pulmonar, cardíaca, neurológica, cerebral o psiquiátrica, o signos y síntomas de dichas enfermedades. - Cualquier circunstancia que, en opinión del investigador, afecte a la seguridad o la capacidad del paciente para participar en este ensayo o que comprometa la calidad de los datos. - Cualquier comportamiento suicida en los últimos 2 años (por ejemplo, intento real, intento interrumpido, intento frustrado, o actos o comportamiento preparatorios). - Cualquier ideación suicida de tipo 4 o 5 sobre el C-SSRS en los últimos 3 meses (es decir, pensamientos suicidas activos con método e intención pero sin plan específico, o pensamientos suicidas activos con método, intención y plan). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1) Occurrence of treatment emergent adverse events (TEAE) up to the end of maintenance treatment period including REP (i.e., 16 weeks after the last study treatment). |
1) Aparición de acontecimientos adversos surgidos durante el tratamiento (AAST) hasta el final del período de tratamiento de mantenimiento, incluyendo el PER (es decir, 16 semanas después del último tratamiento del ensayo). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1) 120 weeks |
1) 120 semanas |
|
E.5.2 | Secondary end point(s) |
1) Percentage change in total abscess and inflammatory nodule (AN) count from baseline up to Week 12. 2) Percentage change in total draining fistula (DF) count from baseline up to Week 12. 3) Hidradenitis Suppurativa Clinical Response (HiSCR) up to Week 12. 4) Change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) value up to Week 12. 5) Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score of 0 or 1 up to Week 12. 6) Absolute change from baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) score up to Week 12. 7) Occurence of at least one flare (defined as at least 25 % increase in AN count with a minimum increase of 2 relative to baseline) up to Week 12. 8) Achievement of at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in Patient’s Global Assessment of HS Pain up to Week 12. |
1) Cambio porcentual respecto al inicio en el recuento total de abscesos y nódulos inflamatorios (NI) hasta la semana 12. 2) Cambio porcentual respecto al inicio en el recuento de fístulas supurantes (FS) hasta la semana 12. 3) Respuesta clínica en la hidradenitis supurativa (HiSCR) hasta la semana 12. 4) Cambio respecto al inicio en el valor del sistema internacional de puntuación de la gravedad de la hidradenitis supurativa (IHS4) hasta la semana 12. 5) Puntuación de 0 o 1 en la evaluación global por el médico de la hidradenitis supurativa (HS-PGA) hasta la semana 12. 6) Cambio absoluto desde el valor inicial en la puntuación del índice de intensidad y área de hidradenitis supurativa (HASI) hasta la semana 12. 7) Número de paciente con al menos un brote (definido como un aumento mínimo del 25% en el recuento de NI con un incremento mínimo de 2 respecto al inicio) hasta la semana 12. 8) Número de pacientes con una reducción de al menos el 30% respecto al inicio en la escala de valoración numérica (NRS30) en la evaluación global por parte del médico del dolor en la HS hasta la semana 12. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) week 12 2) week 12 3) week 12 4) week 12 5) week 12 6) week 12 7) week 12 8) week 12 |
1) semana 12 2) semana 12 3) semana 12 4) semana 12 5) semana 12 6) semana 12 7) semana 12 8) semana 12 |
|
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 | 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) | 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 | Information not present in EudraCT |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Solo la visita 1 es ciega. El resto del ensayo es abierto |
Only Visit 1 is BLINDED. Remainder of trial is OPEN LABEL. |
|
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.8.3 |
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 | 30 |
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 |
Australia |
Canada |
United States |
Belgium |
Denmark |
France |
Germany |
Greece |
Hungary |
Italy |
Netherlands |
Norway |
Poland |
Spain |
United Kingdom |
Czechia |
|
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 | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 16 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
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 | 11 |