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A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-Center Study to Evaluate the Efficacy and Safety of nemolizumab in Japanese Atopic Dermatitis Patients with moderate to severe pruritus

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-Center Study to Evaluate the Efficacy and 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-jRCT2080223684
Enrollment
204
Registered
2017-10-20
Start date
2017-10-25
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

investigational material(s) Generic name etc : nemolizumab INN of investigational material : nemolizumab Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investi

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: 1. Patients with body weight 120.0kg 2. Patients with Hepatitis B virus or hepatitis C virus infection 3. Patients with Evidence of tuberculosis (TB) infection 4. Patients with immune deficiency 5. Pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
efficacy Percent change from baseline in pruritus Visual Analogue Scale (VAS) at Week16 Patients will assess pruritus Visual Analogue Scale (VAS) every day.—

Secondary

MeasureTime frame
safety Parcent changet from baseline in Eczema Area and Severity Index (EASI) at Week16 The principal investigator or sub-investigator will assess EASI at each evaluation time point.—

Countries

Japan

Outcome results

None listed

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