A real-world study of ulinumab in the treatment of plaque psoriasis in Chinese adults

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500098963

Enrollment

Unknown

Registered

2025-03-17

Start date

2025-03-20

Completion date

Unknown

Last updated

2026-04-14

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

Conditions

Plaque psoriasis

Interventions

Ulinumab treatment group:None

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old (calculated on the date of signing the informed consent), regardless of gender; 2. The clinical diagnosis was plaque psoriasis; 3. As assessed by the investigator, ulinumab therapy is planned; 4. Voluntarily sign written informed consent;

Exclusion criteria

Exclusion criteria: 1. A history of allergy to the active ingredient or any excipient of the investigational drug product or to latex; 2. Treatment with ulinumab within 15 weeks prior to screening; 3. Clinically important active infected persons (such as active tuberculosis); 4. Other conditions deemed unsuitable for participation in this clinical study by the investigator;

Design outcomes

Primary

Measure	Time frame
At week 16, PASI scores improved by at least 75% from baseline (PASI 75);	—

Secondary

Measure	Time frame
Proportion of subjects with at least a 50% (PASI 50), 90% (PASI 90), or 100% (PASI 100) improvement in PASI score from baseline at Week 16;Proportion of subjects achieving PASI 50, PASI 75, PASI 90, and PASI 100 responses at Weeks 28, 40, and 52;Change in PASI score from baseline at Weeks 16, 28, 40, and 52;Change in BSA, PGA, and DLQI from baseline at Weeks 16, 28, 40, and 52;Proportion of subjects with BSA < 3% and BSA <= 1% at Weeks 16, 28, 40, and 52;Proportion of subjects achieving PASI <= 5, PASI <= 3, and PASI = 0 at Weeks 16, 28, 40, and 52;Proportion of subjects with Dermatology Life Quality Index (DLQI) = 0/1 and DLQI <= 3 at Weeks 16, 28, 40, and 52;Proportion of subjects achieving PGA = 0/1 and PGA = 0 at Weeks 16, 28, 40, and 52;Proportion of subjects with scalp involvement who achieved a 50% (PSSI 50), 75% (PSSI 75), 90% (PSSI 90), or 100% (PSSI 100) improvement in PSSI score from baseline at Weeks 16, 28, 40, and 52;Proportion of subjects with nail involvement who achieved a 50% (mNAPSI 50), 75% (mNAPSI 75), 90% (mNAPSI 90), or 100% (mNAPSI 100) improvement in mNAPSI score from baseline at Weeks 16, 28, 40, and 5;	—

Measure

Time frame

Proportion of subjects with at least a 50% (PASI 50), 90% (PASI 90), or 100% (PASI 100) improvement in PASI score from baseline at Week 16;Proportion of subjects achieving PASI 50, PASI 75, PASI 90, and PASI 100 responses at Weeks 28, 40, and 52;Change in PASI score from baseline at Weeks 16, 28, 40, and 52;Change in BSA, PGA, and DLQI from baseline at Weeks 16, 28, 40, and 52;Proportion of subjects with BSA < 3% and BSA <= 1% at Weeks 16, 28, 40, and 52;Proportion of subjects achieving PASI <= 5, PASI <= 3, and PASI = 0 at Weeks 16, 28, 40, and 52;Proportion of subjects with Dermatology Life Quality Index (DLQI) = 0/1 and DLQI <= 3 at Weeks 16, 28, 40, and 52;Proportion of subjects achieving PGA = 0/1 and PGA = 0 at Weeks 16, 28, 40, and 52;Proportion of subjects with scalp involvement who achieved a 50% (PSSI 50), 75% (PSSI 75), 90% (PSSI 90), or 100% (PSSI 100) improvement in PSSI score from baseline at Weeks 16, 28, 40, and 52;Proportion of subjects with nail involvement who achieved a 50% (mNAPSI 50), 75% (mNAPSI 75), 90% (mNAPSI 90), or 100% (mNAPSI 100) improvement in mNAPSI score from baseline at Weeks 16, 28, 40, and 5;

—

Countries

China

Contacts

Public ContactXinghua Gao

The First Hospital of China Medical University

gaobarry@hotmail.com+86 24 83282837

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026