Trial · 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
NCT05239039, Phase 3, Completed, Boehringer Ingelheim; results first posted 2024-10-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT05239039. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05239039
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT05239039
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 39 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Generalized Pustular Psoriasis
- Interventions
- spesolimab
- First posted
- 2022-02-14
- Last updated
- 2025-10-20
- Results first posted
- 2024-10-09
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 (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 | 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. |
| Secondary | 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. |
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 (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. | Treated set: 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 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. | Treated set: 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 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. | Treated set: all patients who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Occurrence of Treatment Emergent Adverse Events (AEs) | Spesolimab Single Dose Treatment | 18 | Participants | ||
| Occurrence of Treatment Emergent Adverse Events (AEs) | Spesolimab Double Dose Treatment | 12 | Participants | ||
| Occurrence of Treatment Emergent Serious Adverse Events (SAEs) | Spesolimab Single Dose Treatment | 1 | Participants | ||
| Occurrence of Treatment Emergent Serious Adverse Events (SAEs) | Spesolimab Double Dose Treatment | 2 | Participants | ||
| Occurrence of Treatment Emergent Adverse Events of Special Interest (AESIs) | Spesolimab Single Dose Treatment | 1 | Participants | ||
| Occurrence of Treatment Emergent Adverse Events of Special Interest (AESIs) | Spesolimab Double Dose Treatment | 1 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Spesolimab Single Dose Treatment | 24 | |
| Overall Study | STARTED | Spesolimab Double Dose Treatment | 15 | |
| Overall Study | COMPLETED | Spesolimab Single Dose Treatment | 24 | |
| Overall Study | COMPLETED | Spesolimab Double Dose Treatment | 14 | |
| Overall Study | NOT COMPLETED | Spesolimab Single Dose Treatment | 0 | |
| Overall Study | NOT COMPLETED | Spesolimab Double Dose Treatment | 1 |
Source ClinicalTrials.gov
Adverse events52
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 | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Spesolimab Single Dose Treatment | 2 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Spesolimab Double Dose Treatment | 1 | 15 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Spesolimab Single Dose Treatment | 0 | 24 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Spesolimab Double Dose Treatment | 1 | 15 | |
| other | Pyrexia | General disorders | Spesolimab Single Dose Treatment | 3 | 24 | |
| other | Pyrexia | General disorders | Spesolimab Double Dose Treatment | 3 | 15 | |
| other | COVID-19 | Infections and infestations | Spesolimab Single Dose Treatment | 3 | 24 | |
| other | COVID-19 | Infections and infestations | Spesolimab Double Dose Treatment | 6 | 15 | |
| other | Myringitis | Infections and infestations | Spesolimab Single Dose Treatment | 0 | 24 | |
| other | Myringitis | Infections and infestations | Spesolimab Double Dose Treatment | 1 | 15 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Spesolimab Single Dose Treatment | 0 | 24 |
| Total, all-cause mortality | Spesolimab Double Dose Treatment | 0 | 15 |
| Total, other adverse events | Spesolimab Single Dose Treatment | 15 | 24 |
| Total, other adverse events | Spesolimab Double Dose Treatment | 11 | 15 |
| Total, serious adverse events | Spesolimab Single Dose Treatment | 1 | 24 |
| Total, serious adverse events | Spesolimab Double Dose Treatment | 2 | 15 |
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Spesolimab Single Dose Treatment vs Spesolimab Double Dose Treatment: Occurrence of Treatment Emergent Adverse Events (AEs) | Trial comparisons |
| Spesolimab Single Dose Treatment vs Spesolimab Double Dose Treatment: Occurrence of Treatment Emergent Adverse Events of Special Interest (AESIs) | Trial comparisons |
| Spesolimab Single Dose Treatment vs Spesolimab Double Dose Treatment: Occurrence of Treatment Emergent Serious Adverse Events (SAEs) | Trial comparisons |
| Spesolimab Single Dose Treatment vs Spesolimab Double Dose Treatment: deaths from any cause | Trial comparisons |
| Spesolimab Single Dose Treatment vs Spesolimab Double Dose Treatment: serious adverse events | Trial comparisons |
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.
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/NCT05239039
GET https://conductscience.org/api/trials/v1/NCT05239039/events?page=2