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
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patients with Generalized Pustular Psoriasis (GPP) presenting with a flare
|
Drug: spesolimab
spesolimab
|
Outcome Measures
Primary Outcome Measures
- Occurrence of treatment emergent adverse events (TEAEs) [up to 17 weeks]
Secondary Outcome Measures
- Occurrence of treatment emergent serious adverse events (SAEs) [up to 17 weeks]
- Occurrence of treatment emergent adverse events of special interest (AESIs) [up to 17 weeks]
Eligibility Criteria
Criteria
Inclusion criteria
-
Diagnosis of GPP confirmed based on the Japanese Dermatological Association (JDA) guidelines for the management and treatment of GPP.
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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.
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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.
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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.
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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.
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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.
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Active systemic infections (fungal and bacterial disease) during the last 2 weeks prior to drug administration, as assessed by the investigator.
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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.
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Relevant chronic or acute infections, including active tuberculosis (TB), HIV infection or viral hepatitis at the time of drug administration.
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Patients should be evaluated for TB infection prior to initiating treatment with spesolimab.
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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.
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History of allergy / hypersensitivity to systemically administered spesolimab or its excipients.
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nagoya City University Hospital | Aichi, Nagoya | Japan | 467-8602 | |
| 2 | Fujita Health University Hospital | Aichi, Toyoake | Japan | 470-1192 | |
| 3 | Fukuoka University Hospital | Fukuoka, Fukuoka | Japan | 814-0180 | |
| 4 | Asahikawa Medical University Hospital | Hokkaido, Asahikawa | Japan | 078-8510 | |
| 5 | Kagoshima University Hospital | Kagoshima, Kagoshima | Japan | 890-8520 | |
| 6 | Mie University Hospital | Mie, Tsu | Japan | 514-8507 | |
| 7 | Tohoku University Hospital | Miyagi, Sendai | Japan | 980-8574 | |
| 8 | Okayama University Hospital | Okayama, Okayama | Japan | 700-8558 | |
| 9 | Osaka Metropolitan University Hospital | Osaka, Osaka | Japan | 545-8586 | |
| 10 | Saitama Medical University Hospital | Saitama, Iruma-gun | Japan | 350-0495 | |
| 11 | Jichi Medical University Hospital | Tochigi, Shimotsuke | Japan | 329-0498 | |
| 12 | Tokyo Medical University Hachioji Medical Center | Tokyo, Hachioji | Japan | 193-0998 | |
| 13 | Teikyo University Hospital | Tokyo, Itabashi-ku | Japan | 173-8606 | |
| 14 | Tokyo Medical University Hospital | Tokyo, Shinjuku-ku | Japan | 160-0023 |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1368-0073