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

NCT05200247 | Completed Phase 3 Results

• 1 other identifier: 1368-0073
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 9

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.

Conditions

Generalized Pustular Psoriasis

Outcome Measures

Primary Outcomes (1)

• Occurrence of Treatment Emergent Adverse Events (TEAEs)

  Number of patients with any treatment emergent adverse events (TEAEs) is reported. An adverse events (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE that started before first drug intake and deteriorated under treatment were also considered as 'treatment-emergent'.

  From first administration of study drug until last administration of study drug + 16 weeks of follow up, up to 6.3 months.

Secondary Outcomes (2)

• Occurrence of Treatment Emergent Serious Adverse Events (SAEs)

  From first administration of study drug until last administration of study drug + 16 weeks of follow up, up to 6.3 months.

• Occurrence of Treatment Emergent Adverse Events of Special Interest (AESIs)

  From first administration of study drug until last administration of study drug + 16 weeks of follow up, up to 6.3 months.

Study Arms (1)

Spesolimab

EXPERIMENTAL

Drug: spesolimab

Interventions

spesolimab DRUG

solution for infusion

Spesolimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (9)

Nagoya City University Hospital

Aichi, Nagoya, 467-8602, Japan

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

Location

Kagoshima University Hospital

Kagoshima, Kagoshima, 890-8520, Japan

Location

Mie University Hospital

Mie, Tsu, 514-8507, Japan

Location

Tohoku University Hospital

Miyagi, Sendai, 980-8574, Japan

Location

Saitama Medical University Hospital

Saitama, Iruma-gun, 350-0495, Japan

Location

Jichi Medical University Hospital

Tochigi, Shimotsuke, 329-0498, Japan

Location

Teikyo University Hospital

Tokyo, Itabashi-ku, 173-8606, Japan

Location

Tokyo Medical University Hospital

Tokyo, Shinjuku-ku, 160-0023, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Interventions

spesolimab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 20, 2022
• Study Start: February 17, 2022
• Primary Completion: March 20, 2023
• Study Completion: March 20, 2023
• Last Updated: February 25, 2025
• Results First Posted: August 15, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (9)