ReclutandoNCT07681271Registro de ClinicalTrials.gov

A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)

Papulopustular Rosacea

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LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio: De intervención
Fase: Fase 2
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 100 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

This Phase 2 study aims to evaluate whether Bruton's tyrosine kinase (BTK) inhibition with remibrutinib can produce a clinically meaningful reduction in inflammatory lesions in adults with moderate-to-severe papulopustular rosacea, while also assessing safety and tolerability of remibrutinib in this indication.

Leer la descripción completa

This is a multicenter, randomized, participant and Investigator-blinded, placebo-controlled, parallel-group Phase 2 study designed to evaluate the efficacy, safety, and tolerability of remibrutinib in adults with moderate-to-severe PPR. Following a screening period of up to 30 days, which can be extended by a further 2 weeks only to allow washout from rosacea treatments and other systemic therapies as specified in the prohibited medication section, eligible participants will be randomized at baseline to receive either remibrutinib or matching placebo for a 16-week double-blind treatment phase. A safety follow up visit will occur approximately 30 days after the final dose.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Key Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study.
Adult ≥18 years with a clinical diagnosis of PPR.
Moderate-to-severe disease defined by a modified Investigator's Global Assessment (IGA) score of 3 or 4
The presence of 15 - 60 inflammatory (papular/pustular, max. 2 nodular) facial lesions at screening, with at least 15 lesions present at Day 1 (Baseline).
Completed requisite washout of systemic antibiotics (30 days) and other prohibited systemic therapies before randomization.
Willingness to refrain from initiating treatments or undergoing procedures that target or impact PPR during the double-blind period, and to use only protocol-allowed products.

Key Exclusion Criteria:

Presence of more than 2 nodular inflammatory lesions
Any active facial dermatoses or skin disease or condition that may interfere with assessment of PPR (e.g., seborrheic dermatitis, perioral dermatitis, acne, acneiform eruptions from biologic medications, steroid-induced dermatitis resembling rosacea or acne).
History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes
Use of biologics within five half-lives prior to screening or until the expected pharmacodynamic (PD) effect has returned to baseline, whichever is longer; or longer if required by local regulations
Use of small molecules and/or immunosuppressants that are not corticosteroids within 5 half-lives or within 30 days prior to screening, whichever is longer; or longer if required by local regulations
Any use of systemic corticosteroids, systemic antibiotics, or topical treatments (including corticosteroids, antibiotics, ivermectin, azelaic acid, or metronidazole) within 30 days prior to randomization, or any planned use of these agents during the study treatment period.
History of live attenuated vaccine within 6 weeks prior to randomization or requirement to receive these vaccinations at any time while on study treatment.
Use, planned use, or failure to meet the protocol-defined washout periods for prohibited therapies. In particular, patients with pretreatment with remibrutinib or another BTK-inhibitor within 4 months prior to randomization.

Other protocol-defined inclusion/exclusion criteria may apply.

Entiende la evaluación inicial

Tratamiento, grupos y participación

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Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento doble

LOU064

LOU064 administered by oral route

Drug: LOU064

Placebo

Matching placebo

Drug: Placebo

LOU064 DRUG

LOU064 administered by oral route

Placebo DRUG

Matching placebo

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Absolute change from baseline in facial inflammatory lesion count

Plazo: Baseline, Week 16

The facial inflammatory lesion count is defined as the sum of papules, pustules, and nodules present on the face. Lesions are visually counted across the full facial area (forehead, cheeks, nose, chin). A negative value indicates a reduction in lesions (clinical improvement), as lower counts reflect less inflammatory activity.

Medidas secundarias

Proportion of participants with Investigator's Global Assessment (IGA,modified scale without erythema) grade 0 or 1, with at least 2 grade reduction from baseline

Plazo: Baseline, Week 16

The Investigator's Global Assessment is a clinician-reported outcome using a 5-point ordinal scale (0-4). Higher scores indicate more severe disease; lower scores indicate improvement.

0 = Clear

1. = Near clear
2. = Mild
3. = Moderate
4. = Severe

Percentage change from baseline in facial inflammatory lesion count

Plazo: Baseline, Week 16

The facial inflammatory lesion count is defined as the sum of papules, pustules, and nodules present on the face. Lesions are visually counted across the full facial area (forehead, cheeks, nose, chin). Lower values indicate fewer lesions. A reduction from baseline represents clinical improvement.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (17)

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Buscar un centro en este estudio

17 centros

Three A ResearchEl Paso, Texas, United StatesReclutando

Genesis JaramilloCONTACTgenesis@3aresearch.com

Brenda SimpsonPRINCIPAL_INVESTIGATOR

De qué trata este estudio

Acerca de la investigación

¿Quién podría participar?

Tratamiento, grupos y participación

Qué evalúan los investigadores

Medidas principales

Medidas secundarias

Centros de investigación (17)

Equipo y fechas

Contactos oficiales del estudio

Consulta a Wellness Clinical Research