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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 January 2024
• Main ID: NCT05239039
• Date of registration: 03/02/2022
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public 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
• Scientific title: Multi-centre, Open-label, Expanded Access Program of 900mg Intravenous (i.v.) Spesolimab in Patients With Generalized Pustular Psoriasis (GPP) Presenting With a Flare
• Date of first enrolment: March 15, 2022
• Target sample size: 39
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT05239039
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

China

Key inclusion & exclusion criteria

Inclusion criteria

- Diagnosis of Generalized Pustular Psoriasis (GPP), consistent with European Rare and
Severe Psoriasis Expert Network (ERASPEN) criteria, defined as primary, sterile,
macroscopically visible pustules on non-acral skin (excluding cases where pustulation
is restricted to psoriatic plaques). GPP can occur with or without systemic
inflammation, with or without plaque-type psoriasis, and be either relapsing (>1
episode) or persistent (>3 months).

- Patient is experiencing a flare, defined as new or worsening of widespread eruption of
sterile macroscopically visible pustules, with or without systemic inflammation, as
assessed by the treating physician.

- Male or female patients, aged 18 to 75 years at time of enrolment. Women of
childbearing potential (WOCBP) must be willing and able to use a highly effective
method of birth control per International Council for Harmonization (ICH) M3 (R2) that
result in a low failure rate of less than 1% per year when used consistently and
correctly. A list of contraception methods meeting these criteria is provided in the
patient information.

- Signed and dated written informed consent in accordance with International Council for
Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to
admission to the program.

- No satisfactory authorized alternative therapy exists, as assessed by the treating
physician.

Exclusion criteria

- Women who are pregnant, nursing, or who plan to become pregnant while in the program.

-- Women who stop nursing before study drug administration do not need to be excluded
from participating; they should refrain from breastfeeding for 16 weeks after the last
spesolimab infusion.

- Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold Upper Limit
of Normal (ULN) elevation in Aspartate Transaminase (AST) or Alanine Aminotransferase
(ALT) or alkaline phosphatase, or >2-fold ULN elevation in total bilirubin.

- Active systemic infections (fungal and bacterial disease) during the last 2 weeks
prior to drug administration, as assessed by the treating physician.

- Increased risk of infectious complications (e.g. recent pyogenic infection, any
congenital or acquired immunodeficiency (e.g. Human Immunodeficiency Virus (HIV)),
past organ or stem cell transplantation), as assessed by the treating physician.

- Relevant chronic or acute infections, including active tuberculosis (TB), HIV
infection or viral hepatitis at the time of drug administration.

- Patients should be evaluated for TB infection prior to initiating treatment with
spesolimab.

- Anti-TB therapy should be considered, in accordance with local guidelines, prior
to initiating spesolimab in patients with latent TB or a history of TB.

- History of allergy / hypersensitivity to systemically administered spesolimab or its
excipients.

- Any documented active or suspected malignancy or history of malignancy within 5 years
prior to screening, except appropriately treated basal or squamous cell carcinoma of
the skin or in situ carcinoma of uterine cervix.

- Immediate life-threatening flare of GPP requiring intensive care treatment according
to the investigator's judgement. Life-threatening complications include cardiovascular
/ cytokine driven shock, pulmonary distress syndrome, or renal failure.

Further exclusion criteria apply.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Generalized Pustular Psoriasis

Intervention(s)

Drug: spesolimab

Primary Outcome(s)

Occurrence of Treatment Emergent Adverse Events (AEs) [Time Frame: up to 17 weeks]

Secondary Outcome(s)

Occurrence of Treatment Emergent Adverse Events of Special Interest (AESIs) [Time Frame: up to 17 weeks]

Occurrence of Treatment Emergent Serious Adverse Events (SAEs) [Time Frame: up to 17 weeks]

Secondary ID(s)

1368-0077

Source(s) of Monetary Support

Please refer to primary and secondary sponsors