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
- Registration Number
- NCT05200247
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Spesolimab spesolimab -
- Primary Outcome Measures
Name Time Method Occurrence of Treatment Emergent Adverse Events (TEAEs) From first administration of study drug until last administration of study drug + 16 weeks of follow up, up to 6.3 months. 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'.
- Secondary Outcome Measures
Name Time Method 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. Number of patients with treatment emergent serious adverse events (SAEs) is reported.
A serious adverse event (SAE) was defined as any AE which fulfils at least one of the following criteria:
* results in death,
* is life-threatening, which refers to an event in which the patient was at risk of death at the time of the event;
* requires inpatient hospitalisation or prolongation of existing hospitalisation,
* results in persistent or significant disability or incapacity,
* is a congenital anomaly / birth defect,
* is deemed serious for any other reason if it is an important medical event when based on appropriate medical judgement which may jeopardise the patient and may require medical or surgical intervention to prevent one of the other outcomes listed in the above definitions.
* An event that possibly leads to disability will be handled as 'deemed serious for any other reason' and, therefore, reported as an SAE.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. Number of patients with treatment emergent adverse events of special interest (AESIs) is reported.
The term adverse events of special interest (AESI) relates to any specific adverse event (AE) that has been identified at the project level as being of particular concern for prospective safety monitoring and safety assessment within this trial, e.g. the potential for AEs based on knowledge from other compounds in the same class.
The following are considered as AESIs:
* Potential Severe Drug Induced Liver Injury (DILI)
* Systemic hypersensitivity reactions including infusion reactions and anaphylactic reaction
* Severe infections (according to RCTC grading in the ISF)
* Opportunistic and mycobacterium tuberculosis infections
* Peripheral neuropathy.
Trial Locations
- Locations (9)
Tokyo Medical University Hospital
🇯🇵Tokyo, Shinjuku-ku, Japan
Tohoku University Hospital
🇯🇵Miyagi, Sendai, Japan
Jichi Medical University Hospital
🇯🇵Tochigi, Shimotsuke, Japan
Teikyo University Hospital
🇯🇵Tokyo, Itabashi-ku, Japan
Nagoya City University Hospital
🇯🇵Aichi, Nagoya, Japan
Kagoshima University Hospital
🇯🇵Kagoshima, Kagoshima, Japan
Fukuoka University Hospital
🇯🇵Fukuoka, Fukuoka, Japan
Mie University Hospital
🇯🇵Mie, Tsu, Japan
Saitama Medical University Hospital
🇯🇵Saitama, Iruma-gun, Japan