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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 Infant and 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 Infant and Pediatric Atopic Dermatitis Patients with moderate to severe pruritus

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031230174
Enrollment
70
Registered
2023-06-25
Start date
2023-06-25
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

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

Interventions

Sponsors

Nishiura Tomoyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: History of inadequate response of pruritus to Topical corticosteroids or Topical calcineurin inhibitor of appropriate class with fixed-dose regimen for >=4 weeks for atopic dermatitis within the past 1 year History of inadequate response of pruritus to antihistamines or antiallergics with fixed-dose regimen/dosage for >=2 weeks for pruritus of atopic dermatitis within the past 1 year Patients who are appropriately receiving base treatment for atopic dermatitis.

Exclusion criteria

Exclusion criteria: Patients with hepatitis B virus or hepatitis C virus, or whose parents are infected Patients with tuberculosis or suspected of tuberculosis infection Patients with immune deficiency Patients with a history or complication of hypersensitivity to immunoglobulin products Patients complicated with moderate or severe persistent asthma.

Design outcomes

Primary

MeasureTime frame
Change from baseline in itch score weekly average at Week16

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