A Study to Assess Targeted Therapies for Treatment of Adults With Moderate to Severe Psoriasis
A Phase 2 Multicenter Platform Trial of Targeted Therapies for Treatment of Adult Subjects With Moderate to Severe Psoriasis
Psoriasis is a long-term skin disease that causes inflammation, thick skin, and scaly patches on the skin. This study evaluates the safety and effectiveness of risankizumab in combination with ABBV-295 compared with risankizumab alone in adult participants with moderate to severe psoriasis.
Risankizumab is an approved drug for the treatment of moderate to severe psoriasis. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. Participants will receive either risankizumab plus ABBV-295 or risankizumab plus ABBV-295 matching placebo. Around 105 adult participants with moderate to severe psoriasis will be enrolled in the study at approximately 50 sites worldwide.
Participants will receive injections of risankizumab and ABBV-295 or risankizumab and ABBV-295 matching placebo for up to 52 weeks, with a 20-week follow-up period after the last dose of the study.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: ABBVIE CALL CENTER
- Número de teléfono: 844-663-3742
- Correo electrónico: abbvieclinicaltrials@abbvie.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Clinical diagnosis of chronic plaque psoriasis (PsO) with or without psoriatic arthritis for at least 6 months before the Baseline Visit
- Stable moderate to severe chronic plaque psoriasis with or without Psoriatic arthritis (PsA) at both Screening and Baseline Visit defined as follows: ≥ 10% Body Surface Area psoriasis involvement, Static Physician's Global Assessment score of ≥ 3, and PASI score ≥ 12
- Candidates for systemic therapy or phototherapy as assessed by the investigator.
Exclusion Criteria:
- Participants with any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO).
- Participants with a history of current drug-induced PsO or a drug-induced exacerbation of pre-existing PsO.
- Participants with a history of active ongoing inflammatory skin diseases other than PsO (with or without PsA) that could interfere with the assessment of PsO (e.g., hyperkeratotic eczema).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Risankizumab and ABBV-295 Combination Therapy
Participants will receive risankizumab in combinations with ABBV-295 for up to 52 weeks. |
Injection Injection |
|
Comparador activo: Risankizumab and ABBV-295 Matching Placebo
Participants will receive risankizumab with ABBV-295 matching placebo for up to 52 weeks. |
Injection Injection |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants Achieving at least a 90% reduction from Baseline in Psoriasis Area and Severity Index (PASI 90)
Periodo de tiempo: Week 28
|
PASI is a measure of psoriatic disease severity taking into account the overall severity of erythema, induration and scaling, and the extent of affected area in each of four anatomical regions (head, trunk, upper extremities, and lower extremities). PASI scores range from 0 (no psoriasis) to 72 (severe disease over the entire body surface). Higher scores indicate worse disease severity. PASI 90 indicates at least 90% improvement from baseline. |
Week 28
|
|
Number of Participants with Adverse Events (AEs)
Periodo de tiempo: Up to 72 Weeks
|
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
Up to 72 Weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants Achieving 100% Reduction from Baseline in PASI 100
Periodo de tiempo: Week 28
|
PASI is a measure of psoriatic disease severity taking into account the overall severity of erythema, induration and scaling, and the extent of affected area in each of four anatomical regions (head, trunk, upper extremities, and lower extremities). PASI scores range from 0 (no psoriasis) to 72 (severe disease over the entire body surface). Higher scores indicate worse disease severity. PASI 100 indicates at least 100% improvement from baseline. |
Week 28
|
|
Percentage of Participants Achieving ≥10% Body Weight Reduction from Baseline
Periodo de tiempo: Week 28
|
Achievement of at least 10% body weight reduction from Baseline. |
Week 28
|
|
Percent Change from Baseline in Body Weight
Periodo de tiempo: Week 28
|
Percent change from Baseline in body weight. |
Week 28
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: ABBVIE INC., AbbVie
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- M26-507
- 2026-527347-17-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Marco de tiempo para compartir IPD
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Criterios de acceso compartido de IPD
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
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.
producto fabricado y exportado desde los EE. UU.
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