E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) |
Polirradiculoneuropatía Desmielinizante Inflamatoria Crónica (PDIC) |
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E.1.1.1 | Medical condition in easily understood language |
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a rare immune-mediated disorder of the peripheral nerves. |
La Polirradiculoneuropatía desmielinizante inflamatoria crónica (CIDP) es trastorno inmunitario poco frecuente de los nervios periféricos |
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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 | PT |
E.1.2 | Classification code | 10057645 |
E.1.2 | Term | Chronic inflammatory demyelinating polyradiculoneuropathy |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Assess long-term safety and tolerability of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) |
Evaluar la seguridad, tolerabilidad y eficacia a largo plazo de Rozanolixizumab en sujetos con Polirradiculoneuropatía Desmielinizante Inflamatoria Crónica (PDIC) |
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E.2.2 | Secondary objectives of the trial |
Assess long-term clinical efficacy of doses of rozanolixizumab |
Evaluar la eficacia clínica a largo plazo dosis de Rozanolixizumab |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subject who has completed one of the previous rozanolixizumab study(ies) that allow access to the present study (e.g. study CIDP01) - Female subjects of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of 2 months after their final dose of investigational medicinal product (IMP) - Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active during the study and for 3 months after the final administration of IMP |
- Sujeto que ha completado un estudio(s) con rozanolixizumab previo, lo que le permite acceder al presente estudio (por ejemplo, estudio CIDP01) -Las mujeres potencialmente fértiles deben mostrar su conformidad en utilizar un método anticonceptivo altamente efectivo durante el estudio y los 2 meses siguientes a su última dosis del producto en investigación (PEI) - Los varones con parejas potencialmente fértiles deberán utilizar preservativos en sus relaciones sexuales durante el estudio y los 3 meses siguientes a su última dosis del PEI |
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E.4 | Principal exclusion criteria |
- Subject has any medical (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could harm the subject or would compromise the subject’s ability to participate in this study - Subject has a clinically relevant active infection (eg, sepsis, pneumonia, abscess) - Subject has a known hypersensitivity to any components of rozanolixizumab - Subject intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of rozanolixizumab - Subject has an ongoing serious adverse event (SAE) or a medical condition in the parent study that the investigator considers to put the subject at a significantly increased risk of participating in CIDP04 - Subject has any planned elective surgery due to occur during the study dosing period which in the opinion of the investigator could interfere with study procedures |
-Sujeto que presenta un proceso médico (enfermedad aguda o crónica) o psiquiátrico que, en opinión del investigador, podría afectar a su capacidad de participar en este estudio - Sujeto con infección activa clínicamente importante (por ejemplo, sepsis, neumonía, absceso) - Sujeto con hipersensibilidad conocida a cualquiera de los componentes del rozanolixizumab - Sujeto programado para recibir una vacuna con gérmenes vivos durante el curso del estudio o en el plazo de las 7 semanas siguientes a la última dosis de rozanolixizumab - Sujeto con un acontecimiento adverso grave (serious adverse event, SAE) en curso o que presentó un proceso médico en el estudio original que el investigador considera que le pudiera suponer un riesgo considerable si participara en CIDP04 - Sujeto programado para cirugía electiva durante el periodo de tratamiento del estudio que, en opinión del investigador, pudiera interferir con los procedimientos del estudio |
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E.5 End points |
E.5.1 | Primary end point(s) |
Occurrence of treatment-emergent adverse event (TAEs) |
Presentación de un acontecimiento adverso emergente durante el tratamiento (treatment-emergent adverse evento, TAE) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From Baseline until Follow-Up Visit (up to Week 32) |
Desde la visita basal hasta la de seguimiento (hasta la semana 32) |
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E.5.2 | Secondary end point(s) |
No secondary end points are defined. |
No se han definido criterios secundarios de evaluación |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
No secondary end points are defined. |
No se han definido criterios secundarios de evaluación |
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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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability and Immunogenicity |
Tolerabilidad e Inmunogenética |
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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) | 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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 2 |
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 |
Belgium |
Canada |
Denmark |
France |
Germany |
Netherlands |
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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Last Subject Last Visit (LSLV) |
Ultima Visita del Ultimo Sujeto (LSLV) |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |