Clinical trial NCT04614298: A Phase 4 Study of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Moderate to Severe Plaque Psoriasis
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Kirin China Pharmaceutical Co., Ltd.
First posted: 2020-11-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: To evaluate the proportion of subjects achieving 75% improvement from baseline in Psoriasis Area and Severity Index (PASI; PASI 75) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: To evaluate the proportion of subjects achieving 100% improvement from baseline in PASI (PASI 100) at Week 12
timeFrame: Week 12
measure: To evaluate static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12
timeFrame: Week 12
Other outcomes:
measure: Number of patients with treatment-emergent adverse events (TEAEs) or drug-related TEAEs
timeFrame: after received an investigational product until last visit 1 year
Locations:
city: Changchun
country: China
facility: Site 07
city: Changchun
country: China
facility: Site 13
city: Chongqing
country: China
facility: Site 14
city: Hangzhou
country: China
facility: Site 09
city: Hangzhou
country: China
facility: Site 17
city: Hangzhou
country: China
facility: Site 24
city: Nanjing
country: China
facility: Site 25
city: Peking
country: China
facility: Site 01
city: Peking
country: China
facility: Site 03
city: Peking
country: China
facility: Site 04
city: Peking
country: China
facility: Site 10
city: Peking
country: China
facility: Site 11
city: Peking
country: China
facility: Site 12
city: Peking
country: China
facility: Site 21
city: Shanghai
country: China
facility: Site 02
city: Shanghai
country: China
facility: Site 05
city: Shanghai
country: China
facility: Site 08
city: Tianjin
country: China
facility: Site 06
city: Tianjin
country: China
facility: Site 22
city: Urumqi
country: China
facility: Site 23
city: Wenzhou
country: China
facility: Site 16
city: Wuhan
country: China
facility: Site 19
city: Wuhan
country: China
facility: Site 20
city: Xi'an
country: China
facility: Site 15
city: Xi'an
country: China
facility: Site 18
Study officials:
References: