A Phase III, Open-label, Multi-Center Study to Evaluate the long term Safety of nemolizumab in Japanese Atopic Dermatitis Patients with moderate to severe pruritus
Phase 3
Completed
- Conditions
- Atopic dermatitis with pruritus who are inadequately controlled by existing therapies
- Registration Number
- JPRN-jRCT2080223838
- Lead Sponsor
- Maruho Co.,Ltd.
- Brief Summary
The study treatment was safe and well tolerated. Few clinically significant abnormalities of laboratory tests, vital signs or ECGs were noted in the study. The result of pruritus VAS indicated the improvement in AD until Week 52. The improvement tendency in AD continued after Week 52.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 97
Inclusion Criteria
Atopic Dermatitis with moderate or severe pruritus patients
Exclusion Criteria
- Patients with body weight <30.0kg
- Patients with Hepatitis B virus or hepatitis C virus infection
- Patients with Evidence of tuberculosis (TB) infection
- Patients with immune deficiency
- Pregnant or lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method