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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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05200247
Study type Interventional
Source Boehringer Ingelheim
Contact Boehringer Ingelheim
Phone 1-800-243-0127
Email [email protected]
Status Recruiting
Phase Phase 3
Start date February 17, 2022
Completion date March 29, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT03886246 - A 5-year Study to Test BI 655130 in Patients With Generalized Pustular Psoriasis Who Took Part in Previous Studies With BI 655130 Phase 2
Recruiting 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
Active, not recruiting 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 - Effisayilâ„¢ 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 NCT05366855 - Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis Phase 3
Recruiting NCT05352893 - Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP Phase 3