E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hidradenitis Suppurativa (HS) |
Hidrosadenitis supurativa |
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E.1.1.1 | Medical condition in easily understood language |
Hidradenitis Suppurativa, a chronic skin disease that appears after puberty, may lead to painful nodules and scarring in armpits, groin and other areas. Nodules may rupture to form draining tunnels. |
Hidradenitis supurativa, enfermedad crónica cutánea que aparece tras la pubertad, puede provocar nódulos dolorosos y cicatrices en axilas, ingles y otras áreas. |
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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 | 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 |
Evaluate the efficacy of bimekizumab in study participants with moderate to severe Hidradenitis Suppurativa (HS) |
Evaluar la eficacia del bimekizumab en sujetos con HS moderada o severa |
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E.2.2 | Secondary objectives of the trial |
- Evaluate the efficacy of bimekizumab on other measures of disease activity in study participants with moderate to severe HS - Evaluate the safety of bimekizumab in study participants with moderate to severe HS |
-Evaluar la eficacia del bimekizumab frente a otras medidas de actividad de la enfermedad en sujetos con HS moderada o severa. -Evaluar la seguridad del bimekizumab en sujetos con HS moderada o severa. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
For individuals consenting to the pharmacogenetic substudy, blood samples will be drawn for exploratory genetic/epigenetic analyses at specified timepoints. At certain sites, where feasible, representative photographs of the changes in skin will be captured. Photographs will be anonymized. This is optional for study participants and requires a separate informed consent. A decision not to consent does not exclude the study participant from the study. |
Para las personas que dan su consentimiento para el subestudio farmacogenético, se tomarán muestras de sangre para análisis exploratorios genéticos / epigenéticos en momentos específicos. En ciertos centros, donde sea factible, se tomarán fotografías representativas de los cambios en la piel. Las fotografías serán anonimizadas. Esto es opcional para los participantes del estudio y requiere un consentimiento informado por separado. La decisión de no consentir no excluye al participante del estudio. |
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E.3 | Principal inclusion criteria |
- Participant must be at least 18 years of age, at the time of signing the informed consent. If a study participant is under the local age of consent and is at least 18 years of age, written informed consent will be obtained from both the study participant and the legal representative - Study participants must have a diagnosis of Hidradenitis Suppurativa (HS) based on clinical history and physical examination for at least 6 months prior to the Baseline visit - Study participant must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla), 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline visits - Study participant must have moderate to severe HS defined as a total of >/=5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline visits - Study participant must have had an inadequate response to a course of a systemic antibiotic for treatment of HS as assessed by the Investigator through study participant interview and review of medical history - A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) Not a woman of childbearing potential (WOCBP) OR b) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 20 weeks after the last dose of investigational medicinal product (IMP) |
-Los sujetos deberán tener por lo menos 18 años en el momento de firmar el consentimiento informado. Si un sujeto no llega a la edad local de consentimiento y tiene por lo menos 18 años, se obtendrá el consentimiento informado por escrito del sujeto y del representante legal. -Los sujetos deberán presentar diagnóstico de HS en función de la historia clínica y la exploración física desde por lo menos 6 meses antes de la visita Basal. -El sujeto deberá presentar lesiones de HS en por lo menos 2 áreas anatómicas distintas (por ej., axila izquierda y derecha), una de las cuales deberá tener por lo menos estadio de Hurley II o estadio de Hurley III en la visita de Selección y en la visita Basal. -El sujeto deberá tener HS moderada o severa definida como un total de >/=5 lesiones inflamatorias (es decir, número de abscesos más número de nódulos inflamatorios) en la visita de Selección y en la visita Basal. -El sujeto deberá haber tenido una respuesta inadecuada a una tanda de antibiótico sistémico para el tratamiento de HS, según la evaluación del investigador durante la entrevista con el sujeto y la revisión de la historia clínica. - Una mujer será elegible para participar en el estudio si no está embrazada (véase el Apéndice 4 [Sección 10.4] del protocolo completo), no está en período de lactancia y cumple al menos una de las condiciones siguientes: a)No es una mujer potencialmente fértil (WOCBP), según se define en el Apéndice 4 o b)Es una mujer potencialmente fértil pero acepta seguir las normas sobre anticonceptivos que se indican en el Apéndice 4 durante el período de tratamiento y durante un mínimo de 20 semanas después de la última dosis del IMP. |
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E.4 | Principal exclusion criteria |
- Draining tunnel count of >20 at the Baseline Visit - Any other active skin disease or condition (eg, bacterial cellulitis, candida intertrigo, extensive condyloma) that may, in the opinion of the Investigator, interfere with the assessment of hidradenitis suppurativa (HS) - Study participant has a diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease (IBD) - Primary immunosuppressive condition, including taking immunosuppressive therapy following an organ transplant, or has had a splenectomy - Female who is breastfeeding, pregnant, or plans to become pregnant during the study or within 20 weeks following the final dose of investigational medicinal product (IMP) - Active infection or history of certain infection(s) - Active tuberculosis (TB) infection, latent TB infection, high risk of exposure to TB infection, current or history of nontuberculous mycobacterium (NTM) infection - Concurrent malignancy. Study participants with a history of malignancy within the past 5 years prior to the Screening Visit are excluded, EXCEPT if the malignancy was a cutaneous squamous or basal cell carcinoma, or in situ cervical cancer that has been treated and is considered cured - History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease - Known hypersensitivity to any components of bimekizumab or comparative drugs as stated in this protocol - Concomitant and prior medication restrictions - Myocardial infarction or stroke within the 6 months prior to the Screening Visit - Presence of active suicidal ideation, or moderately severe major depression or severe major depression - Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening |
-El sujeto presenta >20 fístulas en la visita Basal. -El sujeto presenta cualquier otra enfermedad o afección cutánea activa (por ej., celulitis bacteriana, intertrigo por cándidas, condiloma extenso) que, a juicio del investigador, pudiera interferir en la evaluación de la HS. -El sujeto presenta diagnóstico de sarcoidosis, lupus eritematoso sistémico o enfermedad intestinal inflamatoria (IBD) activa. -El sujeto tiene una afección inmunosupresora primaria, incluida la toma de inmunosupresores tras un trasplante de órgano, o ha sufrido esplenectomía. -Mujer en fase de lactancia, embarazada o con intención de quedarse embrazada durante el estudio o en las 20 semanas siguientes a la última dosis del IMP. -Infección activa o antecedentes de ciertas infecciones. -Tuberculosis activa conocida (TB) , tuberculosis latente (LTBI), riesgo elevado de exposición a infección tuberculosa , antecedentes o infección pulmonar actual por micobacterias no tuberculosas (NTM) - Neoplasia maligna concurrente. Los sujetos con antecedentes de neoplasia maligna en los 5 años anteriores a la visita de Selección se excluirán del estudio, EXCEPTO si se trataba de carcinoma cutáneo de células escamosas o de células basales, o de cáncer de cuello de útero in situ que haya sido tratado y se considere curado. - Antecedentes de trastorno linfoproliferativo, incluido linfoma, o signos y síntomas actuales compatibles con enfermedad linfoproliferativa. - Hipersensibilidad conocida a alguno de los componentes de bimekizumab o fármacos similares, según se establece en este protocolo. - Restricciones en cuanto a tratamiento previo o concommitante. - Infarto de miocardio o un ictus en los 6 meses anteriores a la visita de Selección. - Presencia de ideación suicida, o depresión mayor moderadamente severa o depresión mayor severa. - Antecedentes de abuso crónico de alcohol o de drogas en los 6 meses anteriores a la Selección. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 |
Porcentaje de pacientes que presenta respuesta HiSCR50 en la semana 16 |
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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. Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16 2. Percentage of participants with Flare by Week 16 3. Absolute change from Baseline in Skin Pain score at Week 16 4. Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 5. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study 6. Percentage of participants with serious adverse events (SAEs) during the study 7. Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study |
1. Porcentaje de pacientes que presenta respuesta HiSCR75 en la semana 16 2. Porcentaje de pacientes con exacerbación en la semana 16 3. Cambio absoluto en la escala de peor dolor cutáneo en la HS entre el momento Basal y la Semana 16 4. Cambio absoluto de la puntuación total del índice de calidad de vida en dermatología (DLQI) entre el momento Basal y la Semana 16 5. Porcentaje de pacientes con Acontecimientos adversos (AE) de aparición durante el tratamiento (TEAE) 6. Porcentaje de pacientes con TEAE graves 7. Porcentaje de pacientes con TEAE que conducen a retirada del estudio |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 2: Week 16 3, 4: From Baseline (Day 1) to Week 16 5, 6, 7:From Baseline (Day 1) until Safety Follow-Up (up to Week 71) |
1, 2: Semana 16 3, 4: Entre el momento Basal y la Semana 16 5, 6, 7: Entre el momento Basal (Día 1) y el Seguimiento de Seguridad ( hasta la semana 71) |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability, Immunogenicity |
Tolerabilidad, inmunogenicidad |
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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 | 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 | 4 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 55 |
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 |
Bulgaria |
Canada |
France |
Germany |
Hungary |
Ireland |
Israel |
Italy |
Japan |
Poland |
Spain |
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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LVLS |
Última Visita del Último Paciente |
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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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |