E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prurigo Nodularis |
Prurigo Nodularis |
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E.1.1.1 | Medical condition in easily understood language |
Prurigo nodularis, also known as nodular prurigo, is a skin disease characterised by pruritic (itchy) nodules which usually appear on the arms or legs. |
Prurigo nodularis, también conocido como prurigo nodular, es una enfermedad de la piel caracterizada por nódulos pruriginosos (que pican) que suelen aparecer en los brazos o las piernas. |
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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 | 10037084 |
E.1.2 | Term | Prurigo nodularis |
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 |
To establish the efficacy of INCB054707 in Prurigo nodularis. |
Establecer la eficacia del INCB054707 en el Prurigo nodularis. |
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E.2.2 | Secondary objectives of the trial |
- To further assess the treatment effects of INCB054707. - To evaluate the safety and tolerability of INCB054707. |
- Evaluar los efectos del tratamiento con INCB054707. - Evaluar la seguridad y la tolerabilidad de INCB054707. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Ability to comprehend and willingness to sign a written ICF for the study. 2. Men and women 18 to 75 years of age. 3. Clinical diagnosis of PN for at least 3 months before screening. 4. Inadequate response or intolerant to ongoing or prior PN therapy. 5. ≥ 20 nodules at screening and Day 1. 6. Nodules on ≥ 2 different body regions at screening and Day 1. 7. IGA score ≥ 3 at screening and Day 1. 8. Pruritus as defined by the following: a. Screening: Itch NRS score ≥ 5 based on recall for the week preceding screening. b. Day 1: Average Itch NRS ≥ 5 for the week before Day 1. 9. Willingness to avoid pregnancy or fathering children. |
1. Capacidad de comprensión y voluntad de firmar un consentimiento informado escrito para el estudio. 2. Hombres y mujeres de 18 a 75 años de edad. 3. Diagnóstico clínico de PN durante al menos 3 meses antes del cribado. 4. Respuesta inadecuada o intolerancia a la terapia de PN en curso o previa. 5. ≥ 20 nódulos en el cribado y en el día 1. 6. Nódulos en ≥ 2 regiones corporales diferentes en el cribado y en el Día 1. 7. Puntuación IGA ≥ 3 en el cribado y en el Día 1. 8. Prurito definido por lo siguiente: a. Cribado: Puntuación de NRS de picor ≥ 5 basada en el recuerdo de la semana anterior al cribado. b. Día 1: Promedio de NRS de picor ≥ 5 durante la semana anterior al Día 1. 9. Voluntad de evitar el embarazo o la paternidad. |
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E.4 | Principal exclusion criteria |
1. Have chronic pruritus due to a condition other than PN (eg, such as scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease, excoriation syndrome, cholestatic liver disease, chronic kidney disease). 2. Have neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis. 3. Current use of a medication known to cause pruritus. 4. Current use of anticoagulants or medications known to cause thrombocytopenia. 5. Received a live vaccine within 6 weeks before the Day 1 visit. 6. Received dupilumab within 8 weeks before the Day 1 visit. 7. Prior treatment with a JAK inhibitor. 8. Planning to receive a live vaccine during the course of the study or within 6 weeks after the last dose of study drug. 9. Uncontrolled thyroid function at screening as determined by the investigator.
For a full list of Exclusion criteria please refer to the Protocol |
1. Tener prurito crónico debido a una condición distinta a la PN (por ejemplo, como sarna, picadura de insectos, liquen simple crónico, psoriasis, acné, foliculitis, hurgado habitual, papulosis linfomatoide, dermatitis actínica crónica, dermatitis herpetiforme, esporotricosis, enfermedad bullosa, síndrome de excoriación, enfermedad hepática colestásica, enfermedad renal crónica). 2. Tener prurito neuropático y psicógeno como, por ejemplo, notalgia parestésica, prurito braquiorradial, neuropatía de fibras pequeñas, síndrome de picadura de piel o parasitosis delirante. 3. Uso actual de un medicamento que se sabe que causa prurito. 4. Uso actual de anticoagulantes o medicamentos conocidos por causar trombocitopenia. 5. Haber recibido una vacuna viva en las 6 semanas anteriores a la visita del día 1. 6. Haber recibido dupilumab en las 8 semanas anteriores a la visita del día 1. 7. Tratamiento previo con un inhibidor de JAK. 8. Planean recibir una vacuna viva durante el transcurso del estudio o dentro de las 6 semanas posteriores a la última dosis del fármaco del estudio. 9. Función tiroidea no controlada en el momento del cribado, según determine el investigador.
Para ver la lista completa de criterios de exclusión, consulte el Protocolo |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of participants achieving ≥ 4-point improvement in Itch NRS score at Week 16. |
Proporción de participantes que logran una mejora de ≥ 4 puntos en la puntuación NRS del picor en la semana 16. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
• Proportion of participants achieving IGA-TS (IGA score of 0 or 1 with a ≥ 2-grade improvement from baseline) at Week 16. • Time to ≥ 4-point improvement from baseline in Itch NRS score. • The type, frequency, and severity of AEs, including the results of physical examinations, and evaluation of vital signs, ECGs, and laboratory data. |
- Proporción de participantes que logran un IGA-TS (puntuación de IGA de 0 o 1 con una mejora de ≥ 2 grados respecto al valor inicial) en la semana 16. - Tiempo hasta una mejora de ≥ 4 puntos desde el inicio en la puntuación NRS de picor. - El tipo, la frecuencia y la gravedad de los EA, incluidos los resultados de los exámenes físicos y la evaluación de los signos vitales, los ECG y los datos de laboratorio. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 16 and throughout the study |
Semana 16 y durante todo el estudio |
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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 | 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 | 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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 |
Canada |
Germany |
Poland |
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
|
Last Visit Last Subject |
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 | 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 | 6 |