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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 Pediatric 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 Pediatric Atopic Dermatitis Patients with moderate to severe pruritus

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080225289
Enrollment
80
Registered
2020-07-22
Start date
2020-09-04
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

Pruritus of atopic dermatitis which is inadequately controlled by the currently available therapy

Interventions

investigational material(s) Generic name etc : nemolizumab INN of investigational material : nemolizumab Therapeutic category code : 639 Other biological preparations Dosage and Administration for Inv

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 <15.0kg -Patients with Hepatitis B virus or hepatitis C virus infection -Patients with Evidence of tuberculosis (TB) infection -Patients with immune deficiency -Patients with moderate or severe asthma

Design outcomes

Primary

MeasureTime frame
efficacy Change from baseline in itch score at Week16—

Secondary

MeasureTime frame
efficacy Parcent changet from baseline in Eczema Area and Severity Index (EASI) at Week16—

Countries

Japan

Contacts

Public ContactClinical Trials Information

Maruho Co.,Ltd. Kyoto R&D Center

ctinfo@mii.maruho.co.jp+81-75-325-3279

Outcome results

None listed

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