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

Primary Purpose

Moderate to Severe Plaque Psoriasis

Status
Withdrawn
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
KHK4827-Active
KHK4827-Placebo
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Plaque Psoriasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site 07
  • Site 13
  • Site 14
  • Site 09
  • Site 17
  • Site 24
  • Site 25
  • Site 01
  • Site 03
  • Site 04
  • Site 10
  • Site 11
  • Site 12
  • Site 21
  • Site 02
  • Site 05
  • Site 08
  • Site 06
  • Site 22
  • Site 23
  • Site 16
  • Site 19
  • Site 20
  • Site 15
  • Site 18

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

KHK4827 210 mg SC (Subcutaneous)

Placebo SC

Arm Description

Single SC administration

Single SC administration

Outcomes

Primary Outcome Measures

To evaluate the proportion of subjects achieving 75% improvement from baseline in Psoriasis Area and Severity Index (PASI; PASI 75) at Week 12

Secondary Outcome Measures

To evaluate the proportion of subjects achieving 100% improvement from baseline in PASI (PASI 100) at Week 12
To evaluate static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12

Full Information

First Posted
October 27, 2020
Last Updated
September 24, 2021
Sponsor
Kyowa Kirin Co., Ltd.
Collaborators
Kyowa Kirin China Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04614298
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Due to the reconsideration of KHK4827's business in China, it. was decided to withdraw this clinical trial prior to enrollment of first participant.
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
Collaborators
Kyowa Kirin China Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KHK4827 210 mg SC (Subcutaneous)
Arm Type
Experimental
Arm Description
Single SC administration
Arm Title
Placebo SC
Arm Type
Placebo Comparator
Arm Description
Single SC administration
Intervention Type
Drug
Intervention Name(s)
KHK4827-Active
Intervention Description
Single SC administration
Intervention Type
Drug
Intervention Name(s)
KHK4827-Placebo
Intervention Description
Single SC administration
Primary Outcome Measure Information:
Title
To evaluate the proportion of subjects achieving 75% improvement from baseline in Psoriasis Area and Severity Index (PASI; PASI 75) at Week 12
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
To evaluate the proportion of subjects achieving 100% improvement from baseline in PASI (PASI 100) at Week 12
Time Frame
Week 12
Title
To evaluate static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12
Time Frame
Week 12
Other Pre-specified Outcome Measures:
Title
Number of patients with treatment-emergent adverse events (TEAEs) or drug-related TEAEs
Time Frame
after received an investigational product until last visit 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Site 07
City
Changchun
Country
China
Facility Name
Site 13
City
Changchun
Country
China
Facility Name
Site 14
City
Chongqing
Country
China
Facility Name
Site 09
City
Hangzhou
Country
China
Facility Name
Site 17
City
Hangzhou
Country
China
Facility Name
Site 24
City
Hangzhou
Country
China
Facility Name
Site 25
City
Nanjing
Country
China
Facility Name
Site 01
City
Peking
Country
China
Facility Name
Site 03
City
Peking
Country
China
Facility Name
Site 04
City
Peking
Country
China
Facility Name
Site 10
City
Peking
Country
China
Facility Name
Site 11
City
Peking
Country
China
Facility Name
Site 12
City
Peking
Country
China
Facility Name
Site 21
City
Peking
Country
China
Facility Name
Site 02
City
Shanghai
Country
China
Facility Name
Site 05
City
Shanghai
Country
China
Facility Name
Site 08
City
Shanghai
Country
China
Facility Name
Site 06
City
Tianjin
Country
China
Facility Name
Site 22
City
Tianjin
Country
China
Facility Name
Site 23
City
Urumqi
Country
China
Facility Name
Site 16
City
Wenzhou
Country
China
Facility Name
Site 19
City
Wuhan
Country
China
Facility Name
Site 20
City
Wuhan
Country
China
Facility Name
Site 15
City
Xi'an
Country
China
Facility Name
Site 18
City
Xi'an
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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