VIS954 for Treating Inflammatory Skin Problems
A Phase 2a, Multicenter, Basket Study of VIS954 in Participants With Inflammatory Skin Diseases
This is a phase 2, multicenter, basket study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of VIS954 in adults with inflammatory skin diseases (ISDs).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Otsuka Call Center
- Número de teléfono: 844-687-8522
- Correo electrónico: otsuka-professionalservices@otsuka-us.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Key Inclusion Criteria
- Participant must be at least 18 years of age or have reached the legal age of consent in their country, whichever is higher.
- HS- Adults with moderate-to-severe HS of at least 6 months' duration, classified as Hurley Stage II or III, with an inadequate response, intolerance, or contraindication to prior standard systemic antibiotic therapy.
- PG-Adults with clinically confirmed moderate-to-severe ulcerative PG requiring systemic therapy and presenting with at least one active ulcerative lesion of less than 6 months' duration.
- BP-Adults with newly diagnosed or relapsing classical BP, confirmed by clinical presentation and direct immunofluorescence and/or BP180/BP230 serology, with moderate disease activity.
Key Exclusion Criteria
- Participants cannot join the study if they have another active skin condition, medical condition, or mental health condition that, in the study doctor's opinion, could affect the study results, increase safety risks, require restricted medications during the study, or make participation unsuitable.
- HS-Lack of adequate response, as determined by the investigator.
- PG-Presence of active infection involving the target ulcer or non-PG mimics that may interfere with assessment of pyoderma gangrenosum disease activity or treatment response.
- BP- Participants with any pemphigoid disease other than classic BP, BP secondary to medications, or any severe comorbid illness.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: HS Cohort: VIS954
Participants with Hidradenitis Suppurativa (HS) will receive VIS954 during the placebo-controlled and treatment period. |
VIS954 solution for injection |
|
Comparador de placebos: HS Cohort: Placebo
Participants with HS will receive placebo in the placebo-controlled period. |
VIS954-matching placebo solution for injection |
|
Experimental: PG Cohort: VIS954
Participants with Pyoderma Gangrenosum (PG) will receive VIS954 during the placebo-controlled and treatment period. |
VIS954 solution for injection |
|
Comparador de placebos: PG Cohort: Placebo
Participants with PG will receive placebo in the placebo-controlled period. |
VIS954-matching placebo solution for injection |
|
Experimental: BP Cohort: VIS954
Participants with Bullous Pemphigoid (BP) will receive VIS954 during the placebo-controlled and treatment period. |
VIS954 solution for injection |
|
Comparador de placebos: BP Cohort: Placebo
Participants with BP received placebo in the placebo-controlled period. |
VIS954-matching placebo solution for injection |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Adverse Events (AEs) and AEs Related to Infection
Periodo de tiempo: Up to Week 36
|
Up to Week 36
|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Laboratory Abnormalities' Events
Periodo de tiempo: Up to Week 36
|
Up to Week 36
|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Vital Signs' Events
Periodo de tiempo: Up to Week 36
|
Up to Week 36
|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Physical Examination Events
Periodo de tiempo: Up to Week 36
|
Up to Week 36
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
HS, PG, and BP Cohorts: C5aR1 Percentage Receptor Occupancy on Circulating Neutrophils
Periodo de tiempo: Predose and at multiple timepoints postdose up to Day 225
|
Predose and at multiple timepoints postdose up to Day 225
|
|
HS, PG, and BP Cohorts: Maximum Plasma Concentration (Cmax) of VIS954
Periodo de tiempo: Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Time to Reach Maximum Plasma Concentration (tmax) of VIS954
Periodo de tiempo: Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUCtau)
Periodo de tiempo: Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Terminal Elimination Half-life (t1/2z)
Periodo de tiempo: Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Apparent Clearance (CL/F)
Periodo de tiempo: Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Apparent Volume of Distribution (Vz/F)
Periodo de tiempo: Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 381-201-00028
- 2026-525969-41-00 (Ctis)
- 1014049 (Otro identificador: Integrated Research Application System (IRAS))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Marco de tiempo para compartir IPD
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Criterios de acceso compartido de IPD
Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .