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

Sponsor

Kyowa Kirin Co., Ltd. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04614298

Collaborator

Kyowa Hakko Kirin China Pharmaceutical Co., LTD. (Industry)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Moderate to Severe Plaque Psoriasis	Drug: KHK4827-Active Drug: KHK4827-Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

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

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

Outcome Measures

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 [Week 12]

Secondary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country
1	Site 07	Changchun	China
2	Site 13	Changchun	China
3	Site 14	Chongqing	China
4	Site 09	Hangzhou	China
5	Site 17	Hangzhou	China
6	Site 24	Hangzhou	China
7	Site 25	Nanjing	China
8	Site 01	Peking	China
9	Site 03	Peking	China
10	Site 04	Peking	China
11	Site 10	Peking	China
12	Site 11	Peking	China
13	Site 12	Peking	China
14	Site 21	Peking	China
15	Site 02	Shanghai	China
16	Site 05	Shanghai	China
17	Site 08	Shanghai	China
18	Site 06	Tianjin	China
19	Site 22	Tianjin	China
20	Site 23	Urumqi	China
21	Site 16	Wenzhou	China
22	Site 19	Wuhan	China
23	Site 20	Wuhan	China
24	Site 15	Xi'an	China
25	Site 18	Xi'an	China

Sponsors and Collaborators

Kyowa Kirin Co., Ltd.
Kyowa Hakko Kirin China Pharmaceutical Co., LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kyowa Kirin Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04614298

Other Study ID Numbers:

4827-CN001

First Posted:

Nov 3, 2020

Last Update Posted:

Sep 30, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Psoriasis

Brodalumab

Study Results

No Results Posted as of Sep 30, 2021