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Efficacy and Safety of Bimekizumab in Chinese Patients With Moderate-to-Severe Plaque Psoriasis: A Single-Center Prospective Observational Study

Efficacy and Safety of Bimekizumab in Chinese Patients With Moderate-to-Severe Plaque Psoriasis: A Single-Center Prospective Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129598
Enrollment
Unknown
Registered
2026-08-06
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Psoriasis

Interventions

Experimental group:Treatment with Bimekizumab

Sponsors

Dematology Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Chinese men or women aged >=18 or older; 2. Patients with moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy, who meet any of the following criteria for moderate to severe plaque psoriasis according to the 'Chinese Psoriasis Diagnosis and Treatment Guidelines 2023' published by the Chinese Medical Association: (1) Psoriasis Area and Severity Index (PASI) score >=3; (2) Body Surface Area (BSA) affected >=3%; (3) Dermatology Life Quality Index (DLQI) score >=6; 3. Based on the investigator's routine clinical judgment and the patient's willingness, treatment with Bimekizumab is intended to be initiated.

Exclusion criteria

Exclusion criteria: 1. History of malignancy; 2. Severe infection; 3. Patients with severe heart failure; 4. Patients with immunodeficiency; 5. Women who are pregnant, breastfeeding, or planning to become pregnant in the near future; 6. Patients with active hepatitis B virus (HBV) infection (according to the *Chinese Guidelines for the Treatment of Psoriasis with Biologics (2021 Edition)*, patients who are HBsAg-positive or HBcAb-positive only must undergo HBV-DNA and liver function tests; active HBV infection is defined as quantitative HBV-DNA positivity accompanied by abnormal liver function or a copy number greater than 10^5/mL. Here, abnormal liver function refers to ALT/AST > upper limit of normal); 7. Patients with active tuberculosis (according to the *Technical Guidelines for Tuberculosis Prevention and Control in China*, active tuberculosis is defined as the presence of clinical symptoms and signs related to tuberculosis, with evidence of active tuberculosis from Mycobacterium tuberculosis-related microbiological, pathological, and imaging tests; see the guidelines for details); 8. History of substance abuse or psychiatric disorders; 9. Allergy to biologics or a history of multiple drug allergies.

Design outcomes

Primary

MeasureTime frame
Psoriasis Area and Severity Index,PASI;

Secondary

MeasureTime frame
Body surface area, BSA;Physician's global assessment, PGA;Nail Psoriasis Severity Index, NAPSI;Dermatology life quality index, DLQI;

Countries

China

Contacts

Public ContactYongfeng Chen

Dematology Hospital of Southern Medical University

gdcyf@163.com+86 20 8725 5081

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026