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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Moderate to Severe Plaque Psoriasis
• Intervention / Treatment: Drug: KHK4827-Active; Drug: KHK4827-Placebo

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Changchun, China
    • Site 07
  • Changchun, China
    • Site 13
  • Chongqing, China
    • Site 14
  • Hangzhou, China
    • Site 09
  • Hangzhou, China
    • Site 17
  • Hangzhou, China
    • Site 24
  • Nanjing, China
    • Site 25
  • Peking, 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
  • Shanghai, China
    • Site 02
  • Shanghai, China
    • Site 05
  • Shanghai, China
    • Site 08
  • Tianjin, China
    • Site 06
  • Tianjin, China
    • Site 22
  • Urumqi, China
    • Site 23
  • Wenzhou, China
    • Site 16
  • Wuhan, China
    • Site 19
  • Wuhan, China
    • Site 20
  • Xi'an, China
    • Site 15
  • Xi'an, China
    • Site 18

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: KHK4827 210 mg SC (Subcutaneous); Single SC administration	Drug: KHK4827-Active; Single SC administration
PLACEBO_COMPARATOR: Placebo SC; Single SC administration	Drug: KHK4827-Placebo; Single SC administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
Number of patients with treatment-emergent adverse events (TEAEs) or drug-related TEAEs	after received an investigational product until last visit 1 year

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.
• Collaborators: Kyowa Hakko Kirin China Pharmaceutical Co., LTD.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2021
• Primary Completion (ANTICIPATED): February 1, 2022
• Study Completion (ANTICIPATED): November 1, 2022

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: November 1, 2020
• First Posted (ACTUAL): November 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 24, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Brodalumab
• Other Study ID Numbers: 4827-CN001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No