Real-World Study of Ustekinumab in the Treatment of Plaque Psoriasis in Chinese Population Aged 6 Years and Above

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500115383

Enrollment

Unknown

Registered

2025-12-25

Start date

2026-01-01

Completion date

Unknown

Last updated

2026-01-05

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

Conditions

Plaque Psoriasis

Interventions

Ustekinumab Group:None

Eligibility

Sex/Gender

All

Age

6 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged >= 6 years old (calculated based on the date of signing the informed consent form), regardless of gender; 2.Clinically diagnosed with plaque psoriasis; 3.Planned to receive ustekinumab treatment as assessed by the investigator; 4.Voluntarily sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1.A history of allergy to the active ingredients or any excipients of the study drug; 2.Prior treatment with ustekinumab within 15 weeks before screening; 3.Clinically significant active infections (e.g., active tuberculosis); 4.Other conditions that the investigator deems inappropriate for participation in this clinical study.

Design outcomes

Primary

Measure	Time frame
The proportion of subjects with at least a 75% improvement in PASI score relative to baseline (PASI 75);	—

Secondary

Measure	Time frame
The proportion of subjects achieving at least a 50% (PASI 50), 90% (PASI 90), and 100% (PASI 100) improvement from baseline in PASI score (16 weeks);Proportion of subjects achieving PASI 50, PASI 75, PASI 90, and PASI 100 responses (at weeks 28, 40, and 52);Change in PASI score relative to baseline (weeks 16, 28, 40, 52);Changes in BSA, PGA, and DLQI relative to baseline (weeks 16, 28, 40, 52);Proportion of subjects achieving BSA <3% and BSA <=1% (weeks 16, 28, 40, 52);Proportion of subjects achieving PASI <=5, PASI <=3, PASI = 0 (weeks 16, 28, 40, 52);Dermatology Life Quality Index (DLQI) = 0/1, proportion of subjects with DLQI <= 3 (weeks 16, 28, 40, 52);Proportion of subjects achieving PGA=0/1 and PGA=0 (weeks 16, 28, 40, 52);The proportion of subjects with scalp involvement achieving 50% (PSSI50), 75% (PSSI75), 90% (PSSI90), and 100% (PSSI100) improvement in PSSI scores from baseline (at weeks 16, 28, 40, and 52);The proportion of subjects with nail involvement who achieved a 50% (mNAPSI 50), 75% (mNAPSI 75), 90% (mNAPSI 90), and 100% (mNAPSI 100) improvement in mNAPSI score from baseline (at weeks 16, 28, 40, and 52);	—

Measure

Time frame

The proportion of subjects achieving at least a 50% (PASI 50), 90% (PASI 90), and 100% (PASI 100) improvement from baseline in PASI score (16 weeks);Proportion of subjects achieving PASI 50, PASI 75, PASI 90, and PASI 100 responses (at weeks 28, 40, and 52);Change in PASI score relative to baseline (weeks 16, 28, 40, 52);Changes in BSA, PGA, and DLQI relative to baseline (weeks 16, 28, 40, 52);Proportion of subjects achieving BSA <3% and BSA <=1% (weeks 16, 28, 40, 52);Proportion of subjects achieving PASI <=5, PASI <=3, PASI = 0 (weeks 16, 28, 40, 52);Dermatology Life Quality Index (DLQI) = 0/1, proportion of subjects with DLQI <= 3 (weeks 16, 28, 40, 52);Proportion of subjects achieving PGA=0/1 and PGA=0 (weeks 16, 28, 40, 52);The proportion of subjects with scalp involvement achieving 50% (PSSI50), 75% (PSSI75), 90% (PSSI90), and 100% (PSSI100) improvement in PSSI scores from baseline (at weeks 16, 28, 40, and 52);The proportion of subjects with nail involvement who achieved a 50% (mNAPSI 50), 75% (mNAPSI 75), 90% (mNAPSI 90), and 100% (mNAPSI 100) improvement in mNAPSI score from baseline (at weeks 16, 28, 40, and 52);

—

Countries

China

Contacts

Public ContactMan Xiaoyong

The Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Outcome results

None listed

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