Exploratory study for molecular profiling of Japanese patients by brodalumab treatment

JRCT ID: jRCTs041190114

Registered date:10/02/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Psoriasis
• Date of first enrollment: 09/03/2020
• Target sample size: 60
• Study type: Interventional
• Intervention(s): 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 weeks.

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Morita Akimichi
• Secondary Sponsor: Kyowa Kirin Co., Ltd.