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

Brief Summary: This Expanded Access Program in China 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. This means that no therapy exists and participation in a clinical study is not possible.

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 times. Participants who benefit from the treatment during that time may repeat the treatment in case they experience a new GPP flare-up. The doctors regularly check participants' health and take note of any unwanted effects.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Spesolimab single dose treatment	spesolimab	Patients with Generalized Pustular Psoriasis (GPP) presenting a flare received a single intravenous dose of 900 milligrams of spesolimab.
Spesolimab double dose treatment	spesolimab	Patients with Generalized Pustular Psoriasis (GPP) presenting a flare received a single intravenous dose of 900 milligrams of spesolimab. One week after the initial dose, patients received a second intravenous single dose of 900 mg of spesolimab due to persistence of flare symptoms.

Primary Outcome Measures

Name	Time	Method
Occurrence of Treatment Emergent Adverse Events (AEs)	From initial drug administration to: end of study treatment + residual effect period or end of study visit. Up to 16 weeks for the single dose group and up to 17 weeks for the double dose group.	This outcome measured the number of patients with any treatment-emergent adverse event (AE). Treatment-emergent AEs are untoward medical events that appear or worsen during treatment.

Secondary Outcome Measures

Name	Time	Method
Occurrence of Treatment Emergent Serious Adverse Events (SAEs)	From initial drug administration to: end of study treatment + residual effect period or end of study visit. Up to 16 weeks for the single dose group and up to 17 weeks for the double dose group.	This outcome measured the number of patients with serious adverse events (SAEs). SAEs are untoward medical occurrences that result in death, are life threatening, require inpatient hospitalisation, require prolongation of existing hospitalisation, result in persistent or significant disability/incapacity, result in a congenital anomaly/birth defect, or are deemed serious for any other medically important reason.
Occurrence of Treatment Emergent Adverse Events of Special Interest (AESIs)	From initial drug administration to: end of study treatment + residual effect period or end of study visit. Up to 16 weeks for the single dose group and up to 17 weeks for the double dose group.	This outcome measured the number of patients with any treatment-emergent adverse event of special interest (AESIs). AESIs relates to any specific AE that has been identified at the project level as being of particular concern for prospective safety monitoring and safety assessment within this program. Potential severe DILIs (drug-induced liver injury), systemic hypersensitivity reactions, severe infections, opportunistic and mycobacterium tuberculosis infections, and peripheral neuropathy were considered as AESIs.

Locations (12): Tianjin Medical University General Hospital
🇨🇳
Tianjin, China
Beijing Friendship Hospital
🇨🇳
Beijing, China
West China Hospital
🇨🇳
Chengdu, China
Southern Medical University Dermatology Hospital
🇨🇳
Guangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳
Hangzhou, China
Hangzhou Third People's Hospital
🇨🇳
Hangzhou, China
Shandong Provincial Hospital of Dermatology
🇨🇳
Jinan, China
Dermatology Hospital, Chinese Academy of Medical Sciences
🇨🇳
Nanjing, China
Shanghai Skin Disease Hospital
🇨🇳
Shanghai, China
The First Hospital of China Medical University
🇨🇳
Shenyang, China
The University of Hong Kong-Shenzhen Hospital
🇨🇳
Shenzhen, China
Wuhan Union Hospital
🇨🇳
Wuhan, China