A Phase II/III, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-Center Study to Evaluate the Efficacy and Safety of nemolizumab in Japanese Prurigo nodularis Patients with moderate to severe pruritus
Phase 2
- Conditions
- Prurigo nodularis with pruritus who are inadequately controlled by existing therapies
- Registration Number
- JPRN-jRCT2011200017
- Lead Sponsor
- ishiura Tomoyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria
Prurigo nodularis with moderate or severe pruritus
Exclusion 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Parcent change from baseline of weekly average in Peak pruritus-Numeric rate scale (PP-NRS) at Week16
- Secondary Outcome Measures
Name Time Method Proportion of subjects achieving IGA 0 or 1 at Week 16