Estudio de Fase 3, Aleatorizado, Doble Ciego, Controlado con Placebo, de Grupos Paralelos para Investigar la Eficacia y Seguridad de Dupilumab en el Tratamiento del Prurito del Liquen Simple Crónico (LSC) en Adultos

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06687980Tipo: INTERVENTIONALInicio: 25 de nov de 2024Fin estimado: 31 de ago de 2026

Resumen

Se trata de un estudio de fase 3, paralelo, de 2 brazos, para el tratamiento. El propósito de este estudio es medir la mejoría del prurito con inyecciones subcutáneas de dupilumab en comparación con inyecciones de placebo en participantes de ambos sexos con una edad mínima de 18 años y diagnóstico de LSC. Detalles del estudio: La duración total del estudio será de hasta 40 semanas. La duración del tratamiento será de hasta 24 semanas. El seguimiento posterior al tratamiento tendrá una duración de 12 semanas. El número de visitas será de 6.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants are eligible to be included in the study only if all of the following criteria apply (at screening and baseline unless otherwise specified):
Participant must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent.
Participants with moderate-to-severe LSC, as defined by Investigator's Global Assessment (IGA) score ≥3 and one or more of the following:
at least 1 single anogenital lesion;
at least 2 lesions including 1 lesion of ≥3 cm in diameter;
at least 1 severe lesion (IGA score = 4).
History of LSC for at least 6 months prior to the screening visit.
On the Worst-Itch Numerical Rating Scale (WI-NRS) ranging from 0 to 10, participants must have an average worst-itch of LSC score of ≥7 in the 7 days prior to Day 1. A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score. For participants who do not have at least 4 daily scores reported during the 7 days immediately preceding the planned randomization date, randomization can be postponed until this requirement is met, but without exceeding the 28-day maximum duration of the screening period.
History of failing a 2-week course of medium-to-superpotent topical corticosteroid (TCS) +/- topical calcineurin inhibitor (TCI) for the treatment of LSC within the last 6 months, unless TCS/TCI are medically not advisable. Patients with documented systemic treatment for LSC (other than antihistamines) in the past 6 months are also considered as inadequate responders to topical treatments and are potentially eligible for treatment with dupilumab after appropriate washout.
Appropriate contraceptive measures

Criterios de exclusión

Participants are excluded from the study if any of the following criteria apply (at screening and baseline unless otherwise specified):
Participants diagnosed with active lesions of prurigo nodularis (broadly distributed nodules) or active lesions of atopic dermatitis (AD) within 6 months, contact dermatitis, psoriasis, cutaneous T-cell lymphoma (CTCL) XE "CTCL" \\f Abbreviation \\t "cutaneous T-cell lymphoma" (or suspected of CTCL), vulvar lichen planus, or vulvar lichen sclerosus.
Presence of skin morbidities other than LSC that, in the opinion of the Investigator, may interfere with the assessment of the study outcomes. For example: scabies, insect bite, folliculitis, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease, lichen planus hypertrophicus.
Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study.
Severe psychiatric disease that, in the Investigator's judgement, would affect the study intervention evaluation.
Having received or planning to use any of the treatments within the timeframe as specified in the protocol.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Intervenciones

drug

Dupilumab

Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection

drug

Placebo

Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection

Ubicaciones

Investigational Site Number : 0320204

Berazategui, Buenos Aires, Argentina

Investigational Site Number : 0320202

San Miguel de Tucumán, Tucumán Province, Argentina

Investigational Site Number : 0320201

Buenos Aires, Argentina

Investigational Site Number : 0320203

Córdoba, Argentina

Patrocinadores

PrincipalSanofi

ColaboradorRegeneron Pharmaceuticals

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

Estudio de Fase 3, Aleatorizado, Doble Ciego, Controlado ... | EligiMed