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Real-world study on the efficacy and safety of spesolimab in Chinese patients with generalized pustular psoriasis, a multi-center, prospective, observational trial

Real-world study on the efficacy and safety of spesolimab in Chinese patients with generalized pustular psoriasis, a multi-center, prospective, observational trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400089387
Enrollment
Unknown
Registered
2024-09-06
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pustular psoriasis

Interventions

treated with spesolimab real world study:None

Sponsors

Second Affiliated Hospital of Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age =18 years old; 2) Generalized pustular psoriasis that meets the European Expert Consensus on Rare and Severe Psoriasis (ERASPEN) criteria; 3) Treat with spesolimab and sign informed consent.

Exclusion criteria

Exclusion criteria: 1) Allergy to spesolimab or its excipients; 2) Patients who started using phototherapy, cyclosporine, methotrexate, acitretin, or biological agents within 2 weeks before receiving the first dose of spesolimab 3) Women who are pregnant, breastfeeding or planning to become pregnant during the trial; 4) Any previous exposure to spesolimab or its IL-36R inhibitor.

Design outcomes

Primary

MeasureTime frame
Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore ;

Secondary

MeasureTime frame
Generalized Pustular Psoriasis Physician Global Assessment (GPPGA);Psoriasis Area and Severity Index for Generalized Pustular Psoriasis (GPPASI) 75;visual analogue scale (VAS);Dermatology Life Quality Index (DLQI);

Countries

China

Contacts

Public ContactMan Xiaoyong

Second Affiliated Hospital of Zhejiang University

manxy@zju.edu.cn+86 136 0051 6219

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026