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A Phase II/III, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-Center Study to Evaluate the Efficacy and Safety of nemolizumab in Japanese Prurigo nodularis Patients with moderate to severe pruritus

A Phase II/III, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-Center Study to Evaluate the Efficacy and Safety of nemolizumab in Japanese Prurigo nodularis Patients with moderate to severe pruritus

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2011200017
Enrollment
210
Registered
2020-12-24
Start date
2020-12-07
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

Prurigo nodularis with pruritus who are inadequately controlled by existing therapies

Interventions

subcutaneous administration of nemolizumab

Sponsors

Nishiura Tomoyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Prurigo nodularis with moderate or severe pruritus

Exclusion criteria

Exclusion criteria: -Patients with immune deficiency -Patients with body weight less than 30.0kg -Patients with Hepatitis B virus or hepatitis C virus infection -Patients with Evidence of tuberculosis (TB) infection -Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Parcent change from baseline of weekly average in Peak pruritus-Numeric rate scale (PP-NRS) at Week16—

Secondary

MeasureTime frame
Proportion of subjects achieving IGA 0 or 1 at Week 16—

Contacts

Public ContactInformation Clinical

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