Trial Outcomes & Findings for 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 NCT05239039)

Last Updated: 2025-10-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

39 participants

Primary outcome timeframe

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.

Results posted on

2025-10-20

Participant Flow

Open-label, multi-centre, single-arm trial, designed to provide early spesolimab to patients with Generalized Pustular Psoriasis (GPP) presenting with a flare and for whom no satisfactory authorised alternative therapy exists and who are unable to participate in a clinical trial, as assessed by the treating physician.

Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the project at any time for any reason given. Close monitoring of all subjects was adhered to throughout the expanded access program (EAP) conduct.

Participant milestones

Participant milestones
Measure	Spesolimab Single Dose Treatment Patients with Generalized Pustular Psoriasis (GPP) presenting a flare received a single intravenous dose of 900 milligrams of spesolimab.	Spesolimab Double Dose Treatment 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.
Overall Study STARTED	24	15
Overall Study COMPLETED	24	14
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Spesolimab Single Dose Treatment Patients with Generalized Pustular Psoriasis (GPP) presenting a flare received a single intravenous dose of 900 milligrams of spesolimab.	Spesolimab Double Dose Treatment 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.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spesolimab Single Dose Treatment n=24 Participants Patients with Generalized Pustular Psoriasis (GPP) presenting a flare received a single intravenous dose of 900 milligrams of spesolimab.	Spesolimab Double Dose Treatment n=15 Participants 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.	Total n=39 Participants Total of all reporting groups
Age, Continuous	39.9 Years STANDARD_DEVIATION 14.7 • n=5 Participants	38.3 Years STANDARD_DEVIATION 15.0 • n=7 Participants	39.3 Years STANDARD_DEVIATION 14.6 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Asian	24 Participants n=5 Participants	15 Participants n=7 Participants	39 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	24 Participants n=5 Participants	15 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Population: Treated set: all patients who received at least one dose of study drug.

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.

Outcome measures

Outcome measures
Measure	Spesolimab Single Dose Treatment n=24 Participants Patients with Generalized Pustular Psoriasis (GPP) presenting a flare received a single intravenous dose of 900 milligrams of spesolimab.	Spesolimab Double Dose Treatment n=15 Participants 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.
Occurrence of Treatment Emergent Adverse Events (AEs)	18 Participants	12 Participants

SECONDARY outcome

Population: Treated set: all patients who received at least one dose of study drug.

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.

Outcome measures

Outcome measures
Measure	Spesolimab Single Dose Treatment n=24 Participants Patients with Generalized Pustular Psoriasis (GPP) presenting a flare received a single intravenous dose of 900 milligrams of spesolimab.	Spesolimab Double Dose Treatment n=15 Participants 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.
Occurrence of Treatment Emergent Serious Adverse Events (SAEs)	1 Participants	2 Participants

SECONDARY outcome

Population: Treated set: all patients who received at least one dose of study drug.

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.

Outcome measures

Outcome measures
Measure	Spesolimab Single Dose Treatment n=24 Participants Patients with Generalized Pustular Psoriasis (GPP) presenting a flare received a single intravenous dose of 900 milligrams of spesolimab.	Spesolimab Double Dose Treatment n=15 Participants 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.
Occurrence of Treatment Emergent Adverse Events of Special Interest (AESIs)	1 Participants	1 Participants

Adverse Events

Spesolimab Single Dose Treatment

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Spesolimab Double Dose Treatment

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Spesolimab Single Dose Treatment n=24 participants at risk Patients with Generalized Pustular Psoriasis (GPP) presenting a flare received a single intravenous dose of 900 milligrams of spesolimab.	Spesolimab Double Dose Treatment n=15 participants at risk 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.
Infections and infestations COVID-19	0.00% 0/24 • 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.	6.7% 1/15 • 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.
Infections and infestations Pneumonia	4.2% 1/24 • 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.	6.7% 1/15 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.2% 1/24 • 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.	0.00% 0/15 • 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.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.00% 0/24 • 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.	6.7% 1/15 • 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.

Other adverse events

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Spesolimab Single Dose Treatment n=24 participants at risk Patients with Generalized Pustular Psoriasis (GPP) presenting a flare received a single intravenous dose of 900 milligrams of spesolimab.	Spesolimab Double Dose Treatment n=15 participants at risk 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.
Blood and lymphatic system disorders Anaemia	8.3% 2/24 • 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.	6.7% 1/15 • 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.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/24 • 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.	6.7% 1/15 • 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.
General disorders Pyrexia	12.5% 3/24 • 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.	20.0% 3/15 • 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.
Infections and infestations COVID-19	12.5% 3/24 • 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.	40.0% 6/15 • 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.
Infections and infestations Myringitis	0.00% 0/24 • 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.	6.7% 1/15 • 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.
Infections and infestations Nasopharyngitis	8.3% 2/24 • 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.	0.00% 0/15 • 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.
Infections and infestations Tinea versicolour	0.00% 0/24 • 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.	6.7% 1/15 • 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.
Infections and infestations Upper respiratory tract infection	16.7% 4/24 • 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.	0.00% 0/15 • 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.
Infections and infestations Urinary tract infection	8.3% 2/24 • 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.	0.00% 0/15 • 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.
Investigations Blood albumin decreased	0.00% 0/24 • 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.	6.7% 1/15 • 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.
Investigations Neutrophil count increased	0.00% 0/24 • 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.	6.7% 1/15 • 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.
Investigations Prealbumin decreased	0.00% 0/24 • 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.	6.7% 1/15 • 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.
Investigations White blood cell count increased	0.00% 0/24 • 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.	6.7% 1/15 • 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.
Metabolism and nutrition disorders Hyperuricaemia	12.5% 3/24 • 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.	0.00% 0/15 • 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.
Metabolism and nutrition disorders Hypokalaemia	8.3% 2/24 • 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.	6.7% 1/15 • 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.
Metabolism and nutrition disorders Hypoproteinaemia	12.5% 3/24 • 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.	6.7% 1/15 • 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.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/24 • 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.	6.7% 1/15 • 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.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/24 • 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.	6.7% 1/15 • 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.
Skin and subcutaneous tissue disorders Excessive granulation tissue	0.00% 0/24 • 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.	6.7% 1/15 • 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.
Skin and subcutaneous tissue disorders Pruritus	12.5% 3/24 • 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.	6.7% 1/15 • 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.
Skin and subcutaneous tissue disorders Rash	8.3% 2/24 • 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.	0.00% 0/15 • 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.
Skin and subcutaneous tissue disorders Urticaria	8.3% 2/24 • 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.	0.00% 0/15 • 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.