A study on the efficacy and safety of ustekinumab in patients with moderate to severe plaque psoriasis who have an insufficient response to other biological agents.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500111403

Enrollment

Unknown

Registered

2025-10-30

Start date

2025-11-02

Completion date

Unknown

Last updated

2025-11-03

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

Conditions

Moderate to severe plaque psoriasis

Interventions

Ustekinumab treatment Group:None

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 or above, gender not limited; 2. Meet the diagnostic criteria for moderate to severe plaque psoriasis (confirmed clinically and/or pathologically, severity classification shown in Table 1); 3. Insufficient response after receiving at least one systemic biological agent (such as TNF-a inhibitor, IL-17/23 inhibitor, etc.) for standardized treatment (full dose, full course) (such as PASI improvement rate < 50% after 12 weeks of treatment), or disease recurrence/progression during the treatment period; 4. After evaluation by the researchers, it is planned to receive ustekinumab treatment in accordance with the standard procedure; 5. Sign the informed consent form and be able to cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Combined with other serious autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus), malignant tumors, active infections (such as active tuberculosis); 2. Systemic immunosuppressants (such as methotrexate, cyclosporine, etc.) or phototherapy have been used in the past 4 weeks, or other biological agents are planned to be used during the study period; 3. Severe liver and kidney dysfunction (ALT/AST > 3×ULN, Cr > 1.5×ULN) or mental illness (unable to conduct follow-up assessment); 4. Allergic to or contraindicated to ustekinumab (including excipients); 5. Pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
The proportion of study participants whose PASI score improved by at least 75% compared to the baseline in the 16th week (PASI 75);	—

Secondary

Measure	Time frame
The proportion of study participants whose PASI scores improved by at least 50% (PASI 50), 90% (PASI 90), and 100% (PASI 100) compared to the baseline (16 weeks);The proportion of study participants who achieved PASI 50, PASI 75, PASI 90, and PASI 100 responses (at 28, 40, and 52 weeks);Changes in PASI score relative to baseline (at weeks 16, 28, 40, and 52);Changes in BSA, PGA, and DLQI from baseline (weeks 16, 28, 40, and 52);The proportion of study participants with BSA < 3% and BSA=1% (at 16, 28, 40, and 52 weeks);The proportions of study participants achieving PASI=5, PASI=3, and PASI=0 (at 16, 28, 40, and 52 weeks);The proportion of study participants with a dermatology quality of life index (DLQI) of 0/1 and DLQI of 2 to 5 (at 16, 28, 40, and 52 weeks);The proportion of study participants reaching PGA=0/1 and PGA=0 (at 16, 28, 40, and 52 weeks);The proportions of study participants with scalp involvement whose PSSI scores improved by 50% (PSSI 50), 75% (PSSI 75), 90% (PSSI 90), and 100% (PSSI 100) compared to the baseline (at 16, 28, 40, and 52 weeks);The proportions of study participants (at 16, 28, 40, and 52 weeks) whose mNAPSI scores improved by 50% (mNAPSI 50), 75% (mNAPSI 75), 90% (mNAPSI 90), and 100% (mNAPSI 100) compared to the baseline;	—

Measure

Time frame

The proportion of study participants whose PASI scores improved by at least 50% (PASI 50), 90% (PASI 90), and 100% (PASI 100) compared to the baseline (16 weeks);The proportion of study participants who achieved PASI 50, PASI 75, PASI 90, and PASI 100 responses (at 28, 40, and 52 weeks);Changes in PASI score relative to baseline (at weeks 16, 28, 40, and 52);Changes in BSA, PGA, and DLQI from baseline (weeks 16, 28, 40, and 52);The proportion of study participants with BSA < 3% and BSA=1% (at 16, 28, 40, and 52 weeks);The proportions of study participants achieving PASI=5, PASI=3, and PASI=0 (at 16, 28, 40, and 52 weeks);The proportion of study participants with a dermatology quality of life index (DLQI) of 0/1 and DLQI of 2 to 5 (at 16, 28, 40, and 52 weeks);The proportion of study participants reaching PGA=0/1 and PGA=0 (at 16, 28, 40, and 52 weeks);The proportions of study participants with scalp involvement whose PSSI scores improved by 50% (PSSI 50), 75% (PSSI 75), 90% (PSSI 90), and 100% (PSSI 100) compared to the baseline (at 16, 28, 40, and 52 weeks);The proportions of study participants (at 16, 28, 40, and 52 weeks) whose mNAPSI scores improved by 50% (mNAPSI 50), 75% (mNAPSI 75), 90% (mNAPSI 90), and 100% (mNAPSI 100) compared to the baseline;

—

Countries

China

Contacts

Public ContactZhu Guannan

Dermatology Hospital of Southern Medical University

342043462@qq.com+86 135 8041 3200

Outcome results

None listed

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