A Phase 4 Study of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis

Kyowa Kirin

Status and phase: Withdrawn; Phase 4

Conditions: Moderate to Severe Plaque Psoriasis

Treatments: Drug: KHK4827-Active; Drug: KHK4827-Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04614298

4827-CN001

Details and patient eligibility

About

The objective of this study is assessing the efficacy and safety of brodalumab in Chinese subjects with moderate to severe plaque psoriasis.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

KHK4827 210 mg SC (Subcutaneous)

Experimental group

Description:

Single SC administration

Treatment:

Drug: KHK4827-Active

Placebo SC

Placebo Comparator group

Description:

Single SC administration

Treatment:

Drug: KHK4827-Placebo