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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223838
Enrollment
80
Registered
2018-03-13
Start date
2018-03-20
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

Atopic dermatitis with pruritus who are inadequately controlled by existing therapies

Interventions

Sponsors

Maruho Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Atopic Dermatitis with moderate or severe pruritus patients

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
safety Safety assessmemt Adverse event/Laboratory tests/Vital signs/ECG

Secondary

MeasureTime frame
efficacy pruritus Visual Analogue Scale(VAS) Patients will assess pruritus Visual Analogue Scale(VAS)

Countries

Japan

Outcome results

None listed

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