Trial · NCT05200247

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

NCT05200247, Phase 3, Completed, Boehringer Ingelheim; results first posted 2024-08-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT05200247. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05200247

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT05200247
Status: Completed
Phases: Phase 3
Enrollment: 11 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Generalized Pustular Psoriasis
Interventions: spesolimab
First posted: 2022-01-20
Last updated: 2025-02-25
Results first posted: 2024-08-15

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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.
Secondary	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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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.	Treated Set (TS): This patient set includes all patients who received at least one dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	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.	Treated Set (TS): This patient set includes all patients who received at least one dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	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.	Treated Set (TS): This patient set includes all patients who received at least one dose of study drug.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Occurrence of Treatment Emergent Adverse Events (TEAEs)	Spesolimab 900 mg i.v. SD	7	Participants
Occurrence of Treatment Emergent Serious Adverse Events (SAEs)	Spesolimab 900 mg i.v. SD	0	Participants
Occurrence of Treatment Emergent Adverse Events of Special Interest (AESIs)	Spesolimab 900 mg i.v. SD	0	Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Spesolimab 900 mg i.v. SD	11
Overall Study	COMPLETED	Spesolimab 900 mg i.v. SD	11
Overall Study	NOT COMPLETED	Spesolimab 900 mg i.v. SD	0

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Constipation	Gastrointestinal disorders	Spesolimab 900 mg i.v. SD	1	11
other	Chest pain	General disorders	Spesolimab 900 mg i.v. SD	1	11
other	Face oedema	General disorders	Spesolimab 900 mg i.v. SD	1	11
other	Malaise	General disorders	Spesolimab 900 mg i.v. SD	1	11
other	Periodontitis	Infections and infestations	Spesolimab 900 mg i.v. SD	1	11
other	Wound	Injury, poisoning and procedural complications	Spesolimab 900 mg i.v. SD	1	11
other	Coronavirus test positive	Investigations	Spesolimab 900 mg i.v. SD	1	11
other	Transaminases increased	Investigations	Spesolimab 900 mg i.v. SD	1	11
other	Headache	Nervous system disorders	Spesolimab 900 mg i.v. SD	1	11
other	Pollakiuria	Renal and urinary disorders	Spesolimab 900 mg i.v. SD	1	11

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Spesolimab 900 mg i.v. SD	0	11
Total, other adverse events	Spesolimab 900 mg i.v. SD	7	11
Total, serious adverse events	Spesolimab 900 mg i.v. SD	0	11

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05200247

GET https://conductscience.org/api/trials/v1/NCT05200247/registered

API reference For AI assistants