an expanded access trial in japan to provide spesolimab to people with a flare-up in generalized pustular psoriasis who have no other treatment options

Conditions: Generalized Pustular Psoriasis

Summary: this expanded access trial in japan is open to people with a serious skin disease called generalized pustular psoriasis (gpp). this program provides a medicine called spesolimab to people with a gpp flare-up who have no alternative treatment options. participants get a single infusion of spesolimab into a vein. they can get another spesolimab infusion one week after the first infusion if the doctors think it is helpful. participants are in the program for about 4 months and visit the study site about 5 to 6 times. the doctors regularly check participants' health and take note of any unwanted effects.


Eligibility criteria:
inclusion criteria * diagnosis of gpp confirmed based on the japanese dermatological association (jda) guidelines for the management and treatment of gpp. * patient is experiencing a flare, defined as new or worsening of widespread eruption of sterile macroscopically visible pustules, with or without systemic inflammation, as assessed by the investigator. * male or female patients, aged 18 to 75 years at time of enrollment. women of childbearing potential (wocbp) must be willing and able to use a highly effective method of birth control per international council for harmonization (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 the patient information. * signed and dated written informed consent in accordance with international council for harmonization-good clinical practice (ich-gcp) and local legislation prior to admission to the trial. * no satisfactory authorised alternative therapy exists, as assessed by the investigator. exclusion criteria * women who are pregnant, nursing, or who plan to become pregnant while in the trial. -- women who stop nursing before study drug administration do not need to be excluded from participating; they should refrain from breastfeeding for 16 weeks after the last spesolimab infusion. * severe, progressive, or uncontrolled hepatic disease, defined as \>3-fold upper level of normal (uln) elevation in aspartate transaminase (ast) or alanine aminotransferase (alt) or alkaline phosphatase, or \>2-fold uln elevation in total bilirubin. * active systemic infections (fungal and bacterial disease) during the last 2 weeks prior to drug administration, as assessed by the investigator. * increased risk of infectious complications (e.g. recent pyogenic infection, any congenital or acquired immunodeficiency (e.g. human immunodeficiency virus (hiv)), past organ or stem cell transplantation), as assessed by the investigator. * relevant chronic or acute infections, including active tuberculosis (tb), hiv infection or viral hepatitis at the time of drug administration. * patients should be evaluated for tb infection prior to initiating treatment with spesolimab. * anti-tb therapy should be considered, in accordance with local guidelines, prior to initiating spesolimab in patients with latent tb or a history of tb. * history of allergy / hypersensitivity to systemically administered spesolimab or its excipients. * any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix. * immediate life-threatening flare of gpp requiring intensive care treatment according to the investigator's judgement. life-threatening complications include cardiovascular / cytokine driven shock, pulmonary distress syndrome, or renal failure. further exclusion criteria apply.