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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04614298
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Kyowa Kirin Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Moderate to Severe Plaque Psoriasis
Arms & Interventions

Arms

Experimental: KHK4827 210 mg SC (Subcutaneous)

Single SC administration

Placebo Comparator: Placebo SC

Single SC administration

Interventions

Drug: - KHK4827-Active

Single SC administration

Drug: - KHK4827-Placebo

Single SC administration

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Site 07, Changchun, China

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Site 13, Changchun, China

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Site 14, Chongqing, China

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Site 09, Hangzhou, China

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Site 24, Hangzhou, China

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Site 25, Nanjing, China

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Site 01, Peking, China

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Site 02, Shanghai, China

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Site 05, Shanghai, China

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Site 08, Shanghai, China

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Site 06, Tianjin, China

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Site 22, Tianjin, China

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Tianjin, ,

Site 23, Urumqi, China

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Urumqi, ,

Site 16, Wenzhou, China

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Wenzhou, ,

Site 19, Wuhan, China

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Wuhan, ,

Site 20, Wuhan, China

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Wuhan, ,

Site 15, Xi'an, China

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Xi'an, ,

Site 18, Xi'an, China

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Xi'an, ,

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