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NCT04614298 Clinical Trial

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

Moderate to Severe Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04614298
Other study ID # 4827-CN001
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date January 2021
Est. completion date November 2022

Study information
Verified date September 2021
Source Kyowa Kirin Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date November 2022
Est. primary completion date February 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

  • Moderate to Severe Plaque Psoriasis
  • Psoriasis

Intervention

Drug:
• KHK4827-Active
Single SC administration
• KHK4827-Placebo
Single SC administration

Locations
Country Name City State
China Site 07 Changchun
China Site 13 Changchun
China Site 14 Chongqing
China Site 09 Hangzhou
China Site 17 Hangzhou
China Site 24 Hangzhou
China Site 25 Nanjing
China Site 01 Peking
China Site 03 Peking
China Site 04 Peking
China Site 10 Peking
China Site 11 Peking
China Site 12 Peking
China Site 21 Peking
China Site 02 Shanghai
China Site 05 Shanghai
China Site 08 Shanghai
China Site 06 Tianjin
China Site 22 Tianjin
China Site 23 Urumqi
China Site 16 Wenzhou
China Site 19 Wuhan
China Site 20 Wuhan
China Site 15 Xi'an
China Site 18 Xi'an

Sponsors (2)
Lead Sponsor Collaborator
Kyowa Kirin Co., Ltd. Kyowa Hakko Kirin China Pharmaceutical Co., LTD.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Other Number of patients with treatment-emergent adverse events (TEAEs) or drug-related TEAEs after received an investigational product until last visit 1 year
Primary 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 To evaluate the proportion of subjects achieving 100% improvement from baseline in PASI (PASI 100) at Week 12 Week 12
Secondary To evaluate static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 Week 12
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