E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hidradenitis Suppurativa |
Hidradenitis 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 hidradenitis supurativa es una enfermedad crónica de la piel que crea protuberancias rojas, hinchadas y dolorosas que pueden abrirse para combinarse y formar 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 two different doses of lutikizumab, a high dose administered every week (EW) or every other week (EOW), and a low dose administered EOW, versus placebo for the treatment of signs and symptoms of moderate to severe HS in adult subjects who have failed anti-TNF therapy. |
El objetivo principal de este estudio es evaluar la seguridad y la eficacia de dos dosis diferentes de lutikizumab, una dosis alta administrada cada semana (EW) o cada dos semanas (EOW), y una dosis baja administrada EOW en comparación con un placebo para el tratamiento de los signos y síntomas de la HS moderada o grave en adultos que no han respondido al tratamiento anti-TNF |
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E.2.2 | Secondary objectives of the trial |
The secondary endpoint is the achievement of at least a 30% reduction and at least 1-unit reduction from Baseline in worst skin pain (maximal daily pain) at Week 16, as assessed by the Patient's Global Assessment (PGA) of Skin Pain (Numeric Rating Scale [NRS] 30) among subjects with baseline NRS ≥ 3. |
El criterio de valoración secundario es la consecución de una reducción de al menos el 30 % y una reducción de al menos una unidad del peor dolor cutáneo (dolor diario máximo) entre el momento basal y la semana 16, según la evaluación global del paciente (PGA) del dolor cutáneo (escala de valoración numérica [EVN] 30) en los sujetos con una EVN basal ≥3. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subjects must be ≥ 18 years of age at Screening with a clinical diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline as determined by the investigator. - A total abscess and inflammatory nodule (AN) count of >= 5 at Baseline - HS lesions must be present in at least 2 distinct anatomic areas. - Must have failed anti-TNF treatment for HS. |
• Los sujetos deberán tener una edad ≥ 18 años en el periodo de selección, un diagnóstico clínico de HS desde al menos un año antes del momento basal según lo determinado por el investigador. • Un recuento total de abscesos y nódulos inflamatorios (AN) ≥5 en el momento basal • presencia de lesiones de HS en dos regiones anatómicas distintas como mínimo. • Los sujetos no habrán respondido al tratamiento anti-TNF para la HS. |
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E.4 | Principal exclusion criteria |
History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (e.g., bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit. |
Antecedentes de enfermedades cutáneas activas distintas de la HS que puedan interferir con la evaluación de la HS, incluidas las infecciones cutáneas (por ejemplo, bacterianas, fúngicas o virales) que requieran tratamiento sistémico en las 4 semanas siguientes a la visita inicial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the achievement of HiSCR at Week 16. HiSCR is defined as at least a 50% reduction from Baseline in the total AN count, with no increase in abscess count and no increase in draining fistula-count relative to Baseline. |
El criterio de valoración principal es la consecución de una RCHS en la semana 16. La RCHS se define como una reducción de al menos el 50 % en el total de AN sin un aumento del número de abscesos ni del número de fístulas supurantes 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 secondary endpoint is the achievement of at least a 30% reduction and at least 1-unit reduction from Baseline in worst skin pain (maximal daily pain) at Week 16, as assessed by the Patient's Global Assessment (PGA) of Skin Pain (Numeric Rating Scale [NRS] 30) among subjects with baseline NRS ≥ 3. |
El criterio de valoración secundario es la consecución de una reducción de al menos el 30 % y una reducción de al menos una unidad del peor dolor cutáneo (dolor diario máximo) entre el momento basal y la semana 16, según la evaluación global del paciente (PGA) del dolor cutáneo (escala de valoración numérica [EVN] 30) en los sujetos con una EVN basal ≥3 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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 |
Germany |
Greece |
Spain |
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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The end-of-study is defined as the date of end of study participation by the last subject in the study (i.e., the date of the last subject's last visit or date of last follow-up contact, whichever is later.) |
El final del estudio se define como la fecha de finalización de la participación en el estudio por parte del último paciente del mismo (es decir, la fecha de la última visita del último paciente o la fecha del último contacto de seguimiento, lo que sea posterior). |
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |