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 | Completed Phase 3 Results

• 1 other identifier: 1368-0077
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 12

Brief Summary

This Expanded Access Program in China 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. This means that no therapy exists and participation in a clinical study is not possible. 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 times. Participants who benefit from the treatment during that time may repeat the treatment in case they experience a new GPP flare-up. The doctors regularly check participants' health and take note of any unwanted effects.

Conditions

Generalized Pustular Psoriasis

Outcome Measures

Primary Outcomes (1)

• Occurrence of Treatment Emergent Adverse Events (AEs)

  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.

  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.

Secondary Outcomes (2)

• 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.

• 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.

Study Arms (2)

Spesolimab single dose treatment

EXPERIMENTAL

Patients with Generalized Pustular Psoriasis (GPP) presenting a flare received a single intravenous dose of 900 milligrams of spesolimab.

Drug: spesolimab

Spesolimab double dose treatment

EXPERIMENTAL

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.

Drug: spesolimab

Interventions

spesolimab DRUG

spesolimab

Spesolimab double dose treatment; Spesolimab single dose treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (12)

Beijing Friendship Hospital

Beijing, 100050, China

Location

West China Hospital

Chengdu, 610041, China

Location

Southern Medical University Dermatology Hospital

Guangzhou, 510091, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, 310009, China

Location

Hangzhou Third People's Hospital

Hangzhou, 310013, China

Location

Shandong Provincial Hospital of Dermatology

Jinan, 250063, China

Location

Dermatology Hospital, Chinese Academy of Medical Sciences

Nanjing, 210000, China

Location

Shanghai Skin Disease Hospital

Shanghai, 200000, China

Location

The First Hospital of China Medical University

Shenyang, 110001, China

Location

The University of Hong Kong-Shenzhen Hospital

Shenzhen, 518053, China

Location

Tianjin Medical University General Hospital

Tianjin, 30052, China

Location

Wuhan Union Hospital

Wuhan, 430022, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Interventions

spesolimab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: March 15, 2022
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: October 20, 2025
• Results First Posted: October 9, 2024

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)