E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hidradenitis Suppurativa |
Hidrosadenitis Supurativa |
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E.1.1.1 | Medical condition in easily understood language |
Hidradenitis Suppurativa is a chronic skin disease that creates red, swollen, painful bumps which can break open to combine and form tunnels in the skin and scars. |
La Hidrosadenitis Supurativa es una enfermedad crónica de la piel que crea protuberancias rojas, inflamadas y dolorosas que pueden romperse combinando y formando túneles en la piel y cicatrices. |
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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 | 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 |
The primary objective of this study is to assess the safety and efficacy of risankizumab dose 1 and dose 2 versus placebo for the treatment of signs and symptoms of moderate to severe HS in adult subjects diagnosed for at least one year before the Baseline visit. |
El objetivo principal de este estudio es evaluar la seguridad y la eficacia de risankizumab dosis 1 y dosis 2 en comparación con placebo para el tratamiento de los signos y síntomas de la HS moderada o grave en adultos diagnosticados al menos un año antes de la visita basal. |
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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 |
• Subjects must be ≥ 18 years old at Screening with a clinical diagnosis of moderate to severe HS (defined as a total AN count of ≥ 5 at Baseline, presence of HS lesions in at least 2 distinct anatomic areas, and draining fistula count of ≤ 20 at Baseline) for at least 1 year prior to Baseline, as determined by the investigator (i.e., through medical history, interview of subject).
• Subjects must have a history of inadequate response or intolerance to an adequate trial of oral antibiotics for treatment of HS.
• Prior exposure to anti-IL12/23/17 (overall, no more than 10% of the study population)
• Prior exposure to anti-TNF (overall, no more than 15% of the study population) |
• Los pacientes deben tener ≥ 18 años en screening y un diagnóstico clínico de HS moderada o grave (definida como un número total de AN ≥ 5 en basal, presencia de lesiones de HS en al menos 2 regiones anatómicas distintas y un recuento de fístulas supurativas ≤ 20 en basal) durante al menos 1 año antes de basal, según lo determinado por el investigador (es decir, mediante la historia médica, entrevista al sujeto)
• Los pacientes deberán tener antecedentes de respuesta insuficiente o intolerancia a un tratamiento adecuado con antibióticos orales para la HS.
• Exposición previa a anti-IL12/23/17 (en general, no más de 10% de la población de estudio)
• Exposición previa a anti-TNF (en general, no más de 15% de la población de estudio) |
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E.4 | Principal exclusion criteria |
No history of active skin disease other than HS that could interfere with the assessment of HS.
No active TB or concurrent treatment for latent TB and no evidence of HBV, HCV or HIV.
No documented active or suspected malignancy or history of any malignancy within the last 5 years.
No history of organ transplantation.
No exposure to other immunomodulatory biologic therapies, including anti-IL-1 within 3 months or 5 half-lives, whichever is longer, prior to Baseline.
No previous treatment with any cell-depleting therapies including but not limited to anti-CD20 within 12 months prior to Baseline or until B cell count returns to normal level. |
No tener antecedentes de otra enfermedad de la piel activa distinta a HS que pudiera interferir con la evaluación de HS.
No tener TB activa o tratamiento concurrente para TB latente ni evidencia de VHB, VHC o VIH
No tener documentado malignidad activa o sospechosa o historia de cualquier malignidad en al menos 5 años.
No tener historia de trasplante de órgano.
No haber estado expuesto a otras terapias bilógicas inmunomoduladoras, incluyendo anti-IL-1, en los últimos 3 meses o 5 vidas medias, lo que sea de mayor duración, antes de basal.
No haber recibido tratamiento previo con terapias de depleción celular incluyendo, pero no limitado a anti-CD20, en los 12 meses antes de basal o hasta que el recuento de células B vuelva a niveles normales. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16. HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule [AN] count, with no increase in abscess or draining fistula counts. |
El criterio de valoración principal es el porcentaje de pacientes que alcancen una respuesta clínica de la hidrosadenitis supurativa (RCHS) en la semana 16. La RCHS se define como una reducción de al menos el 50 % del número total de abscesos y nódulos inflamatorios [AN] con respecto a basal, sin aumento del número de abscesos ni de fístulas supurativas. |
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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) |
Proportion of subjects achieving at least 30% reduction from Baseline in NRS30 in PGA Skin Pain at Week 8 among subjects with Baseline Numerical Rating Scale (NRS) ≥ 3.
Proportion of subjects achieving NRS30 in PGA Skin Pain at Week 16 among subjects with Baseline NRS ≥ 3.
Proportion of subjects who experience at least 25% increase in AN counts with a minimum increase of 2 relative to Baseline during Period A.
Change from Baseline in DLQI at Week 16.
Change from Baseline in HS-related swelling – assessed based on the HSSA at Week 16.
Change from Baseline in HS-related odor – assessed based on the HSSA at Week 16.
Change from Baseline in HS-related worst drainage – assessed based on the HSSA at Week 16. |
Proporción de pacientes que logren una reducción de al menos el 30 % en la escala de valoración numérica (NRS30) en PGA de dolor cutáneo entre basal y la semana 8 entre los pacientes con una puntuación basal ≥ 3 en la escala de valoración numérica (NRS).
Proporción de pacientes que logren una NRS30 en la PGA de dolor cutáneo en la semana 16 entre los pacientes con una NRS basal ≥ 3.
Variación de la inflamación relacionada con la HS, evaluado mediante HSSA, entre basal y la semana 16.
Variación del olor relacionado con la HS, evaluado mediante la HSSA, entre basal y la semana 16.
Variación del drenaje relacionado con la HS, evaluado mediante la HSSA, entre basal y la semana 16. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 8 and Week 16 |
Semana 8 y Semana 16 |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
Period A is Double Blind. Period B is Open |
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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 | 3 |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
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 |
Japan |
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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Last protocol contact or last protocol follow-up of the last subject, whichever is longer. |
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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 | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |