Moderate to Severe Plaque Psoriasis
Conditions
Brief summary
The objective of this study is assessing the efficacy and safety of brodalumab in Chinese subjects with moderate to severe plaque psoriasis.
Interventions
DRUGKHK4827-Placebo
Single SC administration
DRUGKHK4827-Active
Single SC administration
Sponsors
Kyowa Kirin China Pharmaceutical Co., Ltd.
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Those who are ≥18 and ≤70 years of age at the time of signing the written informed consent form * Those who have involved BSA (the percentage (%) of body surface area involved with lesion) ≥10%, PASI (Psoriasis Area and Severity Index) ≥12 and sPGA (static Physician's global assessment) ≥ 3 at screening and at baseline.
Exclusion criteria
* Those who diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis or medication-induced psoriasis * 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 | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the proportion of subjects achieving 100% improvement from baseline in PASI (PASI 100) at Week 12 | Week 12 |
| To evaluate static physician's global assessment (sPGA) of clear or almost clear (0 or 1) at Week 12 | Week 12 |
Other
| Measure | Time frame |
|---|---|
| Number of patients with treatment-emergent adverse events (TEAEs) or drug-related TEAEs | after received an investigational product until last visit 1 year |
Countries
China
Outcome results
None listed