臨床研究等提出・公開システム

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

A 5-year study to test BI 655130 in patients with Generalized Pustular Psoriasis who took part in previous studies with BI 655130

Toi Keita

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

medchiken.jp@boehringer-ingelheim.com

Yamada Nobuko

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

+81-120-189-779

medchiken.jp@boehringer-ingelheim.com

Not Recruiting

Nov. 01, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

Both

Generalized Pustular Psoriasis (GPP)

Drug: BI 655130 (Spesolimab) / Solution for infusion
Drug: BI 655130 (Spesolimab) / Solution for injection

Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment

- The reoccurrence of a GPP flare defined by GPPGA
- Time to first achievement of a GPPGA score of 0 or 1 (Patients received flare rescue treatment)
- A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit
- Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit

+81-52-851-5511

Oct. 02, 2019

Yes

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

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