An open-label, long term extension study to assess the safety and efficacy of BI 655130 treatment in patients with Generalized Pustular Psoriasis (GPP)

Taguchi Aya0 sites131 target enrollmentOctober 20, 2021

Overview

No summary available.

Registry

who.int

Start Date

October 20, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Taguchi Aya

•1\. Male or female patients who have completed the treatment period without premature discontinuation in the previous BI 655130 trial and are willing and able to continue treatment in the current trial
•2\. 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.
•3\. 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

•1\.Treatment with any restricted medication, or any drugs considered by the investigator likely to interfere with the safe conduct of the study since the last visit of the previous BI 655130 trial and during the screening period for the current trial
•2\.Severe, progressive, or uncontrolled hepatic disease, defined as \>3\-fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, or \>2\-fold ULN elevation in total bilirubin
•3\.Patients with congestive heart disease, as assessed by the investigator.
•4\.Relevant chronic or acute infections including human immunodeficiency virus or viral hepatitis. A patient can be re\-screened if the patient was treated and is cured from acute infection.
•5\.History of allergy/hypersensitivity to a systemically administered trial medication agent or its excipients.
•6\.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.
•7\.Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating; they should refrain from breastfeeding up to 16 weeks after the study drug administration