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

• Status: Withdrawn
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Kirin Co., Ltd.
• Collaborator: Kyowa Hakko Kirin China Pharmaceutical Co., LTD.
• Treatments: Brodalumab

Criteria

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.