E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hidradenitis suppurativa |
Hidradénite suppurée |
|
E.1.1.1 | Medical condition in easily understood language |
acne inversa or maladie de Verneuilh |
Acné inversée ou maladie de Verneuil |
|
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 |
To assess the efficacy of the investigational treatments when compared to placebo, in moderate to severe inflammatory HS Patients |
Evaluer l’efficacité des traitements à l’étude, comparés à un placebo, chez des patients atteints d’hidradénite suppurée inflammatoire modérée à sévère |
|
E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of the investigational treatments in Patients with moderate to severe hidradenitis suppurativa (HS) |
Evaluer la sécurité d’emploi et la tolérance aux traitements à l’étude chez des patients atteints d’hidradénite suppurée inflammatoire modérée à sévère |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female, age 18-65 years, at least 50 kg body weight with moderate to severe HS
- Clinically diagnosed HS for at least 12 months prior to screening
- For Cohort A (iscalimab): at least 5 inflammatory lesions, no more than 10 fistulae and at least two anatomical area involved with HS lesions
- For Cohort B (LYS006): at least 3 inflammatory lesions; no more than 10 fistulae and at least two anatomical areas involved with HS lesions
Other protocol-defined inclusion criteria may apply |
- Hommes ou femmes âgés de 18 à 65 ans (inclus), d'un poids corporel d'au moins 50 kg, atteints d’hidradénite suppurée modérée à sévère
- Hidradénite suppuréediagnostiquée cliniquement au moins 12 mois avant la sélection
- Pour la cohorte A (iscalimab) : au moins 5 lésions inflammatoires, pas plus de 10 fistules, et les lésions sont présentes dans au moins 2 régions anatomiques différentes
- Pour la cohorte B (LYS006) : au moins 3 lésions inflammatoires, pas plus de 10 fistules, et les lésions sont présentes dans au moins 2 régions anatomiques différentes
D'autre critères d'inclusion définis par le protocole existent |
|
E.4 | Principal exclusion criteria |
- Use of other investigational drugs at the time of screening, or within 30 days or 5 half-lives of randomization, whichever is longer; or
longer if required by local regulations
- Women of childbearing potential, unless they are using highly effective methods of contraception during dosing and for a minimum of 12 weeks after stopping medication for cohort A (iscalimab) and a minimum of 2 weeks after the last study drug administration for cohort B (LYS006).
- Pregnant or nursing (lactating) women
Other protocol-defined exclusion criteria may apply |
- Administration d’autres médicaments expérimentaux dans les 30 jours précédant l’inclusion dans l’étude ou dans la période correspondant à 5 demi-vies de ces traitements, ou une durée plus longue si nécessaire selon la réglementation locale en vigueur.
- Femme en âge d’avoir des enfants, sauf si elles utilisent une méthode de contraception très efficace pendant toute la durée du traitement et les 12semaines (Cohorte A – iscalimab) ou les 2 semaines (Cohorte B – LYS006) qui suivent la dernière dose du traitement.
- Femmes enceintes ou qui allaitent
D'autre critères d'exclusion définis par le protocole existent |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients achieving hidradenitis suppurativa clinical response after 16 weeks of treatment |
Proportion de patients obtenant une réponse clinique après 16 semaines de traitement |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Number and severity of adverse events
- Physical exam, vital signs, safety laboratory measurements, ECGs |
- Incidence et sévérité des effets indésirables
- Examen clinique, signes vitaux, paramètres biologiques, électrocardiogrammes à la baseline et régulièrement jusqu'à la visite de fin d’étude |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At baseline and repeatedly until study completion |
A l'entrée dans l'étude puis de manière répétée jusqu'à la fin de l'étude |
|
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 | No |
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 | 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 |
Platform study: studies multiple targeted investigational treatments in context of single disease |
|
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
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 |
Denmark |
France |
Germany |
Hungary |
Iceland |
Netherlands |
United States |
|
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
|
LVLS |
Dernière visite du dernier patient |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 16 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |