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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05200247
Other study ID # 1368-0073
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT06100991 - CorEvitas Generalized Pustular Psoriasis (GPP) Drug Safety and Effectiveness Registry
Recruiting NCT06013969 - A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares Phase 4
Completed NCT05512598 - HB0034 in Patients With Generalized Pustular Psoriasis (GPP) Phase 1
Active, not recruiting NCT03886246 - Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study Phase 2
Recruiting NCT05670821 - PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms
Not yet recruiting NCT06323356 - A Study of TAK-279 in Adult Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis Phase 3
Completed NCT05239039 - An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options Phase 3
Completed NCT04399837 - A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis Phase 2
Completed NCT03942042 - A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis Phase 4
Completed NCT03782792 - Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis Phase 2
Completed NCT03619902 - A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis Phase 2
Active, not recruiting NCT04566471 - Palmoplantar Pustulosis and Generalized Pustular Psoriasis: A National Population-based Analysis of Prevalence
Recruiting NCT06295692 - A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis Phase 3
Active, not recruiting NCT05366855 - Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis Phase 3
Completed NCT05352893 - Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP Phase 3

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