A Phase I, Open-label Single Dose Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Nemolizumab in Pediatric Patients With Atopic Dermatitis

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223685

Enrollment

Registered

2017-10-20

Start date

2017-10-18

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Atopic Dermatitis with moderate or severe pruritus

Exclusion criteria

Exclusion criteria: 1. Patients with Hepatitis B virus or hepatitis C virus infection 2. Patients with Evidence of tuberculosis (TB) infection 3. Patients with moderate or severe asthema symptoms 4. Patients with immune deficiency

Design outcomes

Primary

Measure	Time frame
pharmacokinetics Pharmacokinetics Serum concentration of nemolizumab	—

Secondary

Measure	Time frame
safety efficacy Safety assessmemt Adverse event/Laboratory tests/Vital signs/ECG	—

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