E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hidradenitis Suppurativa (also known as Acne inversa) |
Hidradenitis supurativa (tambien conocido como Acne inverso) |
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E.1.1.1 | Medical condition in easily understood language |
A painful, chronic skin disease characterized by recurrent inflamed nodules and abscesses, which may rupture to form fistulas and ooze purulent drainage, and cause subsequent scarring. |
Enfermedad dolorosa,crónica de la piel caracter por nódulos inflamados recurrentes y abscesos, que pueden romperse para formar fístulas y drenaje de exudado purulento, y causar cicatrización posterior |
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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 | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020041 |
E.1.2 | Term | Hidradenitis suppurativa |
E.1.2 | System Organ Class | 100000004858 |
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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 |
Assess the safety and efficacy of adalimumab prior to surgery in subjects with moderate to severe Hidradenitis Suppurativa (HS) who are surgical candidates. |
Evaluar la seguridad y la eficacia de adalimumab antes de la cirugía en sujetos con hidradenitis supurativa (HS) moderada o grave que son candidatos a cirugía. |
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E.2.2 | Secondary objectives of the trial |
- Assess the impact of adalimumab on the planned HS surgical site before surgery - Evaluate the safety and efficacy of adalimumab when used after surgery, and - Evaluate Patient Reported Outcomes (PRO) related to health status, HS-related symptoms, physical functioning, treatment satisfaction, and work/activity impairment. - Evaluate the pharmacokinetics (PK) and immunogenicity of adalimumab. |
- Evaluar el efecto del adalimumab específicamente sobre el foco quirúrgico de HS previsto antes de la cirugía - Evaluar los resultados comunicados por los pacientes (RCP) relacionados con el estado de salud, los síntomas relacionados con la HS (por ejemplo, secreción o piel inflamada), la satisfacción con el tratamiento, la función física y el deterioro laboral o de las actividades. - Evaluar la farmacocinética (FC) y la inmunogenicidad del adalimumab |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male and female subjects at least 18 years of age - Subject must have skin lesions that are diagnostic of HS for at least 1 year (365 days) prior to the Baseline visit - Subject must have at least 3 distinct anatomical regions involved with inflammatory ( also termed ‘active’) HS lesions; plus (a) either an axilla or unilateral inguinal region (limited to the inguinal-crural fold and adjacent areas) that requires excisional surgery (hereinafter designated the “HS surgical site”), and (b) with at least one of the other affected HS regions (e.g., contralateral inguinal region, buttocks, inframammary region; hereinafter designated the 'HS non-surgical sites) rated as Hurley Stage II or III - Subject must have a total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit within the HS non-surgical sites - The HS surgical site must contain at least one active HS lesion - The HS surgical site must require excisional surgery and is large enough to require healing by secondary intention as assessed by the designated surgeon |
- Sujeto de uno u otro sexo mayor de 18 años - El sujeto debe tener lesiones cutáneas que sean diagnósticas de HS durante al menos un año (365 días) antes de la visita basal - El sujeto debe tener un mínimo de tres regiones anatómicas diferentes afectadas por ‘lesiones inflamatorias de HS’ (también denominadas ‘lesiones activas’); más a) Una axila o región inguinal unilateral (limitada al pliegue inguino-crural y las zonas adyacentes) que precisa cirugía por escisión (en adelante, el ‘foco quirúrgico de HS’) y b) Al menos una de las otras regiones afectadas por HS (por ejemplo, región inguinal contralateral, nalgas o región inframamaria; en adelante, los ‘focos no quirúrgicos de HS) en estadio II o III de Hurley. - El sujeto debe tener un recuento total de abscesos y nódulos inflamatorios (AN) igual o superior a 3 en la visita basal en los focos no quirúrgicos de HS - El foco quirúrgico de HS debe contener al menos una lesión activa de HS - El foco quirúrgico de HS debe precisar cirugía por escisión y ser lo bastante extenso como para precisar curación por segunda intención, según la evaluación del cirujano designado. |
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E.4 | Principal exclusion criteria |
- Subject has a draining fistula count of greater than 20 at the Baseline visit - Subject requires surgery at any anatomical site other than an unilateral axilla or inguinal region site - Subject requires surgical management prior to Week 13, based on the designated surgeon's assessment - Subject requires, based on designated surgeon's assessment, excisional surgery with primary closure as the method of closure being most beneficial for the subject |
- El sujeto tiene un recuento de fístulas supurativas superior a 20 en la visita basal - El sujeto requiere cirugía en cualquier foco anatómico distinto de una axila o región inguinal unilateral. - El sujeto requiere tratamiento quirúrgico antes de la semana 13, según la evaluación del cirujano designado - El sujeto requiere, según la evaluación del cirujano designado, cirugía por escisión, siendo el cierre primario el método de cierre más beneficioso en su caso |
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E.5 End points |
E.5.1 | Primary end point(s) |
- The primary efficacy variable is the proportion of subjects achieving HiSCR (Hidradenitis Suppurativa Clinical Response). HiSCR is defined as at least a 50% reduction in the AN count with no increase in abscess count and no increase in draining fistula count relative to baseline. |
La variable principal de eficacia será la proporción de sujetos que logren una RCHS( Respuesta clínica de Hidradenitis Supurativa). La RCHS se define como una reducción del 50%, como mínimo, del recuento de AN sin aumento del número de abscesos ni de fístulas supurativas con respecto al momento basal. |
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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) |
- The proportion of subjects achieving HiSCR-es (defined as the HiSCR excluding the HS surgical site) at Weeks 12 and 24 - The percent change in surface area of the surgical site, and - The proportion of subjects at Week 12 that require less extensive surgical than the surgical plan (determined at Baseline) or no surgery. |
- Proporción de sujetos que logren una RCHS-efq (RCHS con exclusión del foco quirúrgico de HS) en la semana 12 y 24 - Variación porcentual de la superficie del foco quirúrgico y - Proporción de sujetos que, en la semana 12, requieran cirugía menos extensa que el plan quirúrgico documentado en el momento basal o que ya no precisen cirugía. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Weeks 12 and 24 |
Semana 12 y 24 |
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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 | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 42 |
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 |
Brazil |
Canada |
Colombia |
European Union |
Israel |
Mexico |
Norway |
Russian Federation |
Saudi Arabia |
Turkey |
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E.8.7 | Trial has a data monitoring committee | No |
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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LVLS or the last follow-up contact whichever is longer. |
Última visita del ultimo paciente o contacto de seguimiento, lo que conlleve más tiempo. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |