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A multicenter, prospective, observational real-world study evaluating the efficacy and safety of switching biological treatments in patients with moderate to severe plaque psoriasis.

A multicenter, prospective, observational real-world study evaluating the efficacy and safety of switching biological treatments in patients with moderate to severe plaque psoriasis.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092920
Enrollment
Unknown
Registered
2024-11-26
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Psoriasis

Interventions

Cohort 1:Switching from an IL-12/23 inhibitor (ustekinumab) to a biologic agent with a different target
Cohort 2:Switching from an IL-23 inhibitor (guselkumab, tildrakizumab) to a biologic agent with a different target
Cohort 3:Switching from an IL-17 inhibitor (secukinumab, ixekizumab) to a biologic agent with a different target
Cohort 4:Switching from a TNF-a inhibitor (etanercept, infliximab, adalimumab) to a biologic agent with a different target
Cohort 5:Switching from the original biologic agent (IL-12/23 inhibitor or IL-23 inhibitor or IL-17 inhibitor) to another biologic agent with the same target
Cohort 6:Switching from a small molecule targeted drug (such as a PDE4 inhibitor - apremilast, or a TYK2 inhibitor - deucravacitinib) to a biologic agent

Sponsors

Suzhou Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older at the time of signing the informed consent form; 2. Patients previously diagnosed with moderate to severe plaque psoriasis and have undergone systemic treatment; 3. Baseline body surface area (BSA) involvement >=3%, and Physician’s Global Assessment (PGA) score >=2; 4. Currently receiving a biologic or small molecule targeted drug (excluding concurrent treatment with both biologics and small molecule targeted drugs) for psoriasis (within 4 half-lives of the drug), and deemed suitable by the investigator for switching to another biologic treatment; 5. Able to understand and comply with the trial procedures, voluntarily participate in the trial, and provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients determined by the investigator at screening to have other skin diseases, aside from psoriasis, that may interfere with the efficacy evaluation; 2. Patients who are participating in other psoriasis clinical trials at the time of screening.

Design outcomes

Primary

MeasureTime frame
Physician's Global Assessment, PGA;

Secondary

MeasureTime frame
Physician's Global Assessment, PGA;Psoriasis Area and Severity Index, PASI;Body Surface Area, BSA;Dermatology Life Quality Index, DLQI;

Countries

China

Contacts

Public ContactJun Gu

Suzhou Municipal Hospital

gujun79@163.com+86 18930939371

Outcome results

None listed

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