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

Boehringer Ingelheim España S.A.0 sites150 target enrollmentDecember 14, 2021

ConditionsGeneralized Pustular Psoriasis MedDRA version: 21.0Level: LLTClassification code 10037159Term: Psoriasis pustularSystem Organ Class: 100000004858 Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Generalized Pustular Psoriasis
Sponsor: Boehringer Ingelheim España S.A.
Enrollment: 150
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 14, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Boehringer Ingelheim España S.A.

Eligibility Criteria

Inclusion Criteria

•1\. Male or female patients who have completed the treatment period without premature
•discontinuation in the previous BI 655130 trial (1368\-0013 or 1368\-0027\) 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. 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

Exclusion Criteria

•1\. Evidence of flare symptoms of moderate/severe intensity at screening
•2\. Treatment with any restricted medication as specified in Table 4\.2\.2\.1:1, 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 651330 trial and during the screening period for the current trial.
•3\. 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.
•4\. Patients with congestive heart disease, as assessed by the investigator.
•5\. 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.
•6\. 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.