Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Generalized Pustular Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 f...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT05200247
Start Date
February 17 2022
End Date
March 20 2023
Last Update
February 25 2025
Active Locations (9)
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1
Nagoya City University Hospital
Aichi, Nagoya, Japan, 467-8602
2
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan, 814-0180
3
Kagoshima University Hospital
Kagoshima, Kagoshima, Japan, 890-8520
4
Mie University Hospital
Mie, Tsu, Japan, 514-8507