An interventional study to assess patient-reported outcome measures in bradalumab treated patients with moderate to severe plaque psoriasis in Japan

An interventional study to assess patient-reported outcome measures in bradalumab treated patients with moderate to severe plaque psoriasis in Japan - PROMs in brodalumab treated patients with psoriasis in Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027783

Enrollment

Registered

2017-06-16

Start date

2017-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psoriasis

Interventions

Administer subcutaneously 210 mg as brodalumab in the first dose, followed by doses at 1 week later, 2 weeks later, and once every 2 weeks thereafter. In this study, the research duration will be 48

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with plaque psoriasis who aged 18 years or older at the time of informed concent. 2)Patients who have given written informed consect to participate. 3)Patients who are judged to be able to inject oneself with brodalumab by the investigator or subinvestigator at the time of informed concent. 4)Patients who responded inadequately to phototherapies or other existing systemic therapies (except biologics) and who have skin eruptions over 10% or more of the body surface area at enrollment. 5)Patients who were carefully deemed by the investigator or subinvestigator not to continue the treatment protocol with prior biologic(s).

Exclusion criteria

Exclusion criteria: 1)Patients with psoriatic erythroderma, pustular psoriasis and guttate psoriasis at the time of informed concent. 2)Patients with a severe infection or active tuberculosis at the time of informed concent. 3)Patients who are judged by the investigator or subinvestigator to be unsuitable for participation in this study. 4)Patients with joint symptoms at enrollment.

Design outcomes

Primary

Measure	Time frame
Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI) and in Percent Body Surface Area (%BSA) [Time Frame: Week 12, 48] Proportion of Participants Achieving PASI 75, 90 and PASI 100 [Time Frame: Week 12, 48] Mean Change From Baseline on EuroQol - 5 Dimension - 5 Level, Dermatology Life Quality Index, Patient Health Questionnaire - 8, Generalized Anxiety Disorder - 7, Itch Numerical Rating Scale, Skin Pain Numerical Rating Scale, Medical Outcomes Study Sleep Scale, Work Productivity and Activity Impairment-Psoriasis and Treatment Satisfaction Questionnaire for Medication-9 [Time Frame: Week 12, 48] Patient Global Assessment [Time Frame: Week 12, 48]	—

Measure

Time frame

Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI) and in Percent Body Surface Area (%BSA) [Time Frame: Week 12, 48] Proportion of Participants Achieving PASI 75, 90 and PASI 100 [Time Frame: Week 12, 48] Mean Change From Baseline on EuroQol - 5 Dimension - 5 Level, Dermatology Life Quality Index, Patient Health Questionnaire - 8, Generalized Anxiety Disorder - 7, Itch Numerical Rating Scale, Skin Pain Numerical Rating Scale, Medical Outcomes Study Sleep Scale, Work Productivity and Activity Impairment-Psoriasis and Treatment Satisfaction Questionnaire for Medication-9 [Time Frame: Week 12, 48] Patient Global Assessment [Time Frame: Week 12, 48]

—

Countries

Japan

Contacts

Public ContactKenji Kaneko

Kyowa Hakko Kirin Co., Ltd Medical Affairs

ma.cre@kyowa-kirin.co.jp03-5205-7200

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026