A Phase 4 Clinical Study to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy of Brodalumab (KHK4827) in Subjects with Moderate to Severe Plaque Psoriasis

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000039699

Enrollment

Unknown

Registered

2020-11-06

Start date

2020-12-03

Completion date

Unknown

Last updated

2021-02-16

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

Conditions

The treatment of moderate to severe Plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy

Interventions

experimental group:Brodalumab Injection (KHK4827) 210 mg Q2W

control group:Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Those who are >= 18 and = 10%, PASI >= 12 and sPGA >= 3 at screening and at baseline.

Exclusion criteria

Exclusion criteria: 1. Those who diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis or medication-induced psoriasis; 2. Those who have skin conditions other than psoriasis including eczema at the time of the screening that would interfere with evaluations of the study drug.

Design outcomes

Primary

Measure	Time frame
To evaluate the proportion of subjects achieving 75% improvement from baseline in Psoriasis Area and Severity Index (PASI; PASI 75) at Week 12;	—

Secondary

Measure	Time frame
To evaluate the proportion of subjects achieving 100% improvement from baseline in PASI (PASI 100) at Week 12;To evaluate static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12;	—

Countries

China

Contacts

Public ContactZhang Jianzhong

Peking University People's Hospital

rmzjz@126.com+86 18001315877

Outcome results

None listed

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