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 Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05200247
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Generalized Pustular Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Patients with Generalized Pustular Psoriasis (GPP) presenting with a flare

Interventions

Drug: - spesolimab

spesolimab

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Nagoya City University Hospital, Aichi, Nagoya, Japan

Status

Recruiting

Address

Nagoya City University Hospital

Aichi, Nagoya, , 467-8602

Site Contact

Boehringer Ingelheim

nippon@bitrialsupport.com

0120201230

Fujita Health University Hospital, Aichi, Toyoake, Japan

Status

Recruiting

Address

Fujita Health University Hospital

Aichi, Toyoake, , 470-1192

Site Contact

Boehringer Ingelheim

nippon@bitrialsupport.com

0120201230

Fukuoka University Hospital, Fukuoka, Fukuoka, Japan

Status

Recruiting

Address

Fukuoka University Hospital

Fukuoka, Fukuoka, , 814-0180

Site Contact

Boehringer Ingelheim

nippon@bitrialsupport.com

0120201230

Asahikawa Medical University Hospital, Hokkaido, Asahikawa, Japan

Status

Recruiting

Address

Asahikawa Medical University Hospital

Hokkaido, Asahikawa, , 078-8510

Site Contact

Boehringer Ingelheim

nippon@bitrialsupport.com

0120201230

Kagoshima University Hospital, Kagoshima, Kagoshima, Japan

Status

Recruiting

Address

Kagoshima University Hospital

Kagoshima, Kagoshima, , 890-8520

Site Contact

Boehringer Ingelheim

nippon@bitrialsupport.com

0120201230

Mie University Hospital, Mie, Tsu, Japan

Status

Recruiting

Address

Mie University Hospital

Mie, Tsu, , 514-8507

Site Contact

Boehringer Ingelheim

nippon@bitrialsupport.com

0120201230

Tohoku University Hospital, Miyagi, Sendai, Japan

Status

Recruiting

Address

Tohoku University Hospital

Miyagi, Sendai, , 980-8574

Site Contact

Boehringer Ingelheim

nippon@bitrialsupport.com

0120201230

Okayama University Hospital, Okayama, Okayama, Japan

Status

Recruiting

Address

Okayama University Hospital

Okayama, Okayama, , 700-8558

Site Contact

Boehringer Ingelheim

nippon@bitrialsupport.com

0120201230

Osaka Metropolitan University Hospital, Osaka, Osaka, Japan

Status

Recruiting

Address

Osaka Metropolitan University Hospital

Osaka, Osaka, , 545-8586

Site Contact

Boehringer Ingelheim

nippon@bitrialsupport.com

0120201230

Saitama Medical University Hospital, Saitama, Iruma-gun, Japan

Status

Recruiting

Address

Saitama Medical University Hospital

Saitama, Iruma-gun, , 350-0495

Site Contact

Boehringer Ingelheim

nippon@bitrialsupport.com

0120201230

Jichi Medical University Hospital, Tochigi, Shimotsuke, Japan

Status

Recruiting

Address

Jichi Medical University Hospital

Tochigi, Shimotsuke, , 329-0498

Site Contact

Boehringer Ingelheim

nippon@bitrialsupport.com

0120201230

Tokyo, Hachioji, Japan

Status

Recruiting

Address

Tokyo Medical University Hachioji Medical Center

Tokyo, Hachioji, , 193-0998

Site Contact

Boehringer Ingelheim

nippon@bitrialsupport.com

0120201230

Teikyo University Hospital, Tokyo, Itabashi-ku, Japan

Status

Recruiting

Address

Teikyo University Hospital

Tokyo, Itabashi-ku, , 173-8606

Site Contact

Boehringer Ingelheim

nippon@bitrialsupport.com

0120201230

Tokyo Medical University Hospital, Tokyo, Shinjuku-ku, Japan

Status

Recruiting

Address

Tokyo Medical University Hospital

Tokyo, Shinjuku-ku, , 160-0023

Site Contact

Boehringer Ingelheim

nippon@bitrialsupport.com

0120201230

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