Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis

Conditions

• Moderate-to-Severe Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

2 Years - 12 Years

Healthy Volunteers

Not accepted

Interventions

• Nemolizumab — DRUG
  Participants will receive subcutaneous (SC) injection of 10, 20 or 30 milligrams (mg) nemolizumab, every 4 weeks (Q4W) for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight.
• Nemolizumab — DRUG
  Participants will receive SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight.

Study Details

The purpose of this study was to assess the pharmacokinetics (PK), safety, and efficacy of nemolizumab in pediatric participants with moderate-to-severe atopic dermatitis (AD).

Key Dates

Start date

Sep 23, 2021

Status verified

Apr 2026

Primary completion

Apr 28, 2025

Completion

Apr 28, 2025

Study Design

Enrollment

109 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1: Participants aged 7-11 year
  Participants aged 7-11 years will receive nemolizumab for 52 weeks.
• Experimental: Cohort 1.1: Participants aged 7-11 years
  Participants aged 7-11 years will receive nemolizumab for 52 weeks.
• Experimental: Cohort 2: Participants aged 2-6 years
  Participants aged 2-6 years will receive nemolizumab for 52 weeks.

Primary Outcome Measure

Nemolizumab Serum Concentrations [ Time Frame: At Weeks 4, 8, 12, 16, 32 and 52 ]

Locations (14)

Related coverage on Hipa.ai

• Nemolizumab Phase 2 PK Results Posted for Pediatric Atopic Dermatitis
  Nemolizumab · May 26, 2026 · ClinicalTrials.gov

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