A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Nemolizumab in Patients with Acquired Reactive Perforating Collagenosis

JRCT ID: jRCT2021230034

Registered date:09/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acquired Reactive Perforating Collagenosis
• Date of first enrollment: 04/12/2023
• Target sample size: 21
• Study type: Interventional
• Intervention(s): subcutaneous administration

Outcome(s)

• Primary Outcome: Peak pruritus-Numeric rate scale (PP-NRS)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients aged 18 years or older who have been diagnosed with acquired reactive perforating collagen fibrosis according to the diagnostic criteria of the Clinical Practice Guide for Perforated Dermatoses (2020)

Exclude criteria

Patients with immune deficiency
Patients with body weight less than 30.0kg
Patients with Hepatitis B virus or hepatitis C virus infection
Patients with Evidence of tuberculosis (TB) infection
Pregnant or lactating women.

Related Information

• Primary Sponsor: Tomoyuki Nishiura