Exploratory study for molecular profiling of Japanese patients by brodalumab treatment

Exploratory study for molecular profiling of Japanese patients by brodalumab treatment - ESPRIT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041190114

Enrollment

Registered

2020-02-10

Start date

2020-03-09

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 12 w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who have given written informed consent to participate. 2. Patients with plaque psoriasis 3. Patient who aged 18 years or older at the time of informed consent. 4. Patients with a PASI score> 10 or BSA> 10% 5. Patients who met the requirements of the Label

Exclusion criteria

Exclusion criteria: 1. Patients with pustular psoriasis 2. Patients with psoriatic erythroderma 3. Patients who have received brodalumab 4. Patients who took immunosuppressant(steroids(oral, endermic*2(including compound drug)) within 4 weeks before Day1* *1 Day1 is the day first dose of brodalumab in this study *2 Steroids(endermic (including compound drug )) is allowed to be used in area other than the planned biopsy site. 5. Patients with significant infection 6. Patients with active tuberculosis 7. Patients with history of severe hypersensitivity to brodalumab

Design outcomes

Primary

Measure	Time frame
1) Clinical parameters 1. PASI score at 12 weeks 2. PASI score 0 achievement rate at 12 weeks 2) Molecular profile 1. Change from 0 week of molecular profile at 12 weeks 2. Effects of brodalumab treatment on inflammation-related and cardiovascular risk factors at 12 weeks	—

Secondary

Measure	Time frame
1) Clinical parameters 1. sPGA score at 4 weeks 2. BSA at 4 weeks 3. Changes in PASI score over time 4. Change in PASI score 0 achievement rate over time 5. Achievement rate of sPGA score 0 at 12 weeks 6. Change in sPGA score over time 7. Change in the achievement rate of sPGA score 0 8. Changes in BSA over time 9. Search for factors that can predict achievement of PASI score 0 10. Effects of brodalumab treatment on inflammation-related factors at 4 and 12 weeks 2) Molecular profile 1. Difference in molecular profile between PASI score 0 and non-achieved patients at 12 weeks 2. Effect of brodalumab treatment on inflammation-related factors at 2 and 4 weeks 3. Change in molecular profile at 4 weeks from 0 weeks 4. Difference in molecular profile between patients with and without PASI score 0 at 4 weeks 3) All adverse events occurring after brodalumab administration	—

Measure

Time frame

1) Clinical parameters 1. sPGA score at 4 weeks 2. BSA at 4 weeks 3. Changes in PASI score over time 4. Change in PASI score 0 achievement rate over time 5. Achievement rate of sPGA score 0 at 12 weeks 6. Change in sPGA score over time 7. Change in the achievement rate of sPGA score 0 8. Changes in BSA over time 9. Search for factors that can predict achievement of PASI score 0 10. Effects of brodalumab treatment on inflammation-related factors at 4 and 12 weeks 2) Molecular profile 1. Difference in molecular profile between PASI score 0 and non-achieved patients at 12 weeks 2. Effect of brodalumab treatment on inflammation-related factors at 2 and 4 weeks 3. Change in molecular profile at 4 weeks from 0 weeks 4. Difference in molecular profile between patients with and without PASI score 0 at 4 weeks 3) All adverse events occurring after brodalumab administration

—

Contacts

Public ContactAkimichi Morita

Nagoya City University Hospital

amorita@med.nagoya-cu.ac.jp+81-52-851-5511

Outcome results

None listed

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