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
CompletedPhase 3Results postedLast updated 25 February 2025
What this trial tests
Phase 3 trial testing spesolimab in Generalized Pustular Psoriasis in 11 participants. Completed in 20 March 2023.
Adults 18 to 75, any sex, with Generalized Pustular Psoriasis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Occurrence of Treatment Emergent Adverse Events (TEAEs)Primary· 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'.
Group
Value
95% CI
Spesolimab 900 mg i.v. SD
7
Occurrence of Treatment Emergent Serious Adverse Events (SAEs)Secondary· 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
Group
Value
95% CI
Spesolimab 900 mg i.v. SD
0
Occurrence of Treatment Emergent Adverse Events of Special Interest (AESIs)Secondary· 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 anap
Group
Value
95% CI
Spesolimab 900 mg i.v. SD
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From first administration of study drug until last administration of study drug + 16 weeks of follow up, up to 6.3 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05239039 — An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Wh
· Phase 3
· completed
Other recruiting trials for Generalized Pustular Psoriasis
Currently open trials in the same condition.
NCT06477536 — Long-Term Safety and Efficacy of HB0034 in Subjects With Generalized Pustular Psoriasis
· Phase 2, PHASE3
· recruiting
NCT06323356 — A Study of TAK-279 in Adult Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
· Phase 3
· active not recruiting
NCT06295692 — A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
· Phase 3
· active not recruiting
NCT06013969 — A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeate
· Phase 4
· active not recruiting
NCT03886246 — Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Too
· Phase 2
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 25 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05200247.