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

Phase 4

Withdrawn

• Conditions: Moderate to Severe Plaque Psoriasis
• Interventions: Drug: KHK4827-Active; Drug: KHK4827-Placebo

• Registration Number: NCT04614298
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-11-01
• Study First Posted: 2020-11-03
• Study Start: 2021-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-24
• Last Update Posted: 2021-09-30
• Primary Completion: 2022-02
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KHK4827 210 mg SC (Subcutaneous)	KHK4827-Active	Single SC administration
Placebo SC	KHK4827-Placebo	Single SC administration

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (25)

Site 07; 🇨🇳 Changchun, China

Site 18; 🇨🇳 Xi'an, China

Site 13; 🇨🇳 Changchun, China

Site 14; 🇨🇳 Chongqing, China

Site 09; 🇨🇳 Hangzhou, China

Site 24; 🇨🇳 Hangzhou, China

Site 03; 🇨🇳 Peking, China

Site 10; 🇨🇳 Peking, China

Site 21; 🇨🇳 Peking, China

Site 04; 🇨🇳 Peking, China

Site 11; 🇨🇳 Peking, China

Site 02; 🇨🇳 Shanghai, China

Site 06; 🇨🇳 Tianjin, China

Site 20; 🇨🇳 Wuhan, China

Site 17; 🇨🇳 Hangzhou, China

Site 01; 🇨🇳 Peking, China

Site 12; 🇨🇳 Peking, China

Site 05; 🇨🇳 Shanghai, China

Site 08; 🇨🇳 Shanghai, China

Site 23; 🇨🇳 Urumqi, China

Site 22; 🇨🇳 Tianjin, China

Site 15; 🇨🇳 Xi'an, China

Site 16; 🇨🇳 Wenzhou, China

Site 19; 🇨🇳 Wuhan, China

Site 25; 🇨🇳 Nanjing, China