Resumen

Este estudio está abierto a personas con psoriasis pustulosa generalizada (GPP). Solo pueden participar quienes hayan completado el tratamiento en un estudio previo con spesolimab (1368-0013 o 1368-0027). El objetivo de este estudio es determinar qué tan bien toleran las personas con GPP el tratamiento a largo plazo con spesolimab. El estudio también evalúa si spesolimab contribuye a mejorar los síntomas de la GPP y con qué rapidez mejoran los síntomas tras un brote. Todos los participantes reciben spesolimab durante casi 5 años (252 semanas). Según sus síntomas y si presentaron un brote de GPP durante el estudio previo, reciben spesolimab cada pocas semanas. Cuando los participantes tienen un brote de GPP durante este estudio, reciben spesolimab en infusión intravenosa. Los participantes visitan a sus médicos con regularidad. Durante estas visitas, los médicos recopilan información sobre cualquier problema de salud de los participantes. Para evaluar los criterios de valoración del estudio, los médicos examinan periódicamente la piel de los participantes.

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Male or female patients who have completed the treatment period without premature discontinuation in the previous spesolimab trial and are willing and able to continue treatment in the current trial
Women of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in Section 4.2.2.3 as well as in the patient information. Note: A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is not a method of permanent sterilization. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
Signed and dated written informed consent and assent for the current trial 1368-0025, in accordance with ICH-GCP and local legislation prior to admission to the current trial

Criterios de exclusión

Evidence of flare symptoms of moderate/severe intensity at screening.
Treatment with any restricted medication as specified in the protocol, or any drugs considered by the investigator likely to interfere with the safe conduct of the study since the last visit of the previous spesolimab trial and during the screening period for the current trial, with the exception of methotrexate, cyclosporine, or retinoids started following rescue treatment for GPP flare in trial 1368-0027.
Severe, progressive, or uncontrolled hepatic disease, defined as \>3- fold Upper Limit of Normal (ULN) elevation in Aspartate Transaminase (AST) or Alanine Aminotransferase (ALT) or alkaline phosphatase, or \>2- fold ULN elevation in total bilirubin.
Patients with congestive heart disease, as assessed by the investigator.
Relevant chronic or acute infections including human immunodeficiency virus (HIV) or viral hepatitis. A patient can be re-screened if the patient was treated and is cured from acute infection.
Active or Latent tuberculosis (TB):
Patients with active tuberculosis should be excluded
Patients will be screened with Interferon Gamma Release Assay (IGRA) such as QuantiFERON®-TB-Gold Plus or T-spot®. Patients with positive IGRA (indicating active or latent tuberculosis) are excluded unless they have completed treatment for active or latent tuberculosis per investigator discretion, at the time of screening.
Patients with indeterminate QuantiFERON®-TB-Gold Plus or invalid/borderline T-spot® may be retested with IGRA (once) or Tuberculin Skin test (TST).
TST or any alternative test/procedure (as per local standards) to rule out TB can be performed if IGRA is not available or indeterminate. A TST reaction ≥10mm (≥5mm if receiving ≥15mg/d prednisone or other immunosuppressant) is considered positive. Patients with a positive TST are excluded unless they have completed treatment as above.
History of allergy/hypersensitivity to a systemically administered trial medication agent or its excipients.
Any documented active or suspected malignancy at screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.

Effisayil™ ON: Estudio de extensión abierta a largo plazo para evaluar la seguridad y eficacia del tratamiento con spesolimab en pacientes con psoriasis pustulosa generalizada (GPP)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Spesolimab

Spesolimab

Ubicaciones

Hospital Italiano de Buenos Aires

Patrocinadores