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

Generalized Pustular Psoriasis Clinical Trial

Official title:

Multi-centre, Open-label, Expanded Access Trial of Spesolimab i.v. in Patients With Generalized Pustular Psoriasis (GPP) Presenting With a Flare

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05200247
• Other study ID #: 1368-0073
• Status: Completed
• Phase: Phase 3
• Start date: February 17, 2022
• Est. completion date: March 20, 2023

Study information

• Verified date: January 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Generalized Pustular Psoriasis
• Psoriasis

Intervention

Drug:
• spesolimab
solution for infusion

Locations

Country	Name	City	State
Japan	Nagoya City University Hospital	Aichi, Nagoya
Japan	Fukuoka University Hospital	Fukuoka, Fukuoka
Japan	Kagoshima University Hospital	Kagoshima, Kagoshima
Japan	Mie University Hospital	Mie, Tsu
Japan	Tohoku University Hospital	Miyagi, Sendai
Japan	Saitama Medical University Hospital	Saitama, Iruma-gun
Japan	Jichi Medical University Hospital	Tochigi, Shimotsuke
Japan	Teikyo University Hospital	Tokyo, Itabashi-ku
Japan	Tokyo Medical University Hospital	Tokyo, Shinjuku-ku

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of treatment emergent adverse events (TEAEs)		up to 6.3 months.
Secondary	Occurrence of treatment emergent serious adverse events (SAEs)		up to 6.3 months.
Secondary	Occurrence of treatment emergent adverse events of special interest (AESIs)		up to 6.3 months.

External Links

•   Related Info