CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 109 enrolled / 109 target
Drug / intervention
Nemolizumab +1 moredrug
Likely dose
Nemolizumab 30 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04921345
NCT04921345Phase 2CompletedMonitor (1.8/mo)Completion was 14mo ago
CompareCT.gov

A Multicenter, Open-Label, Single-Group Clinical Trial to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab (CD14152) in Pediatric Subjects (Aged 2 to 11 Years) With Moderate-to-Severe Atopic Dermatitis

Galderma R&D·interventional·Posted Jun 10, 2021·Updated Jun 25, 2026

In Brief

A Phase 2 clinical trial evaluating Nemolizumab for Moderate-to-Severe Atopic Dermatitis. Completed, enrolled 109 participants across 23 sites in 5 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsModerate-to-Severe Atopic Dermatitis
CountriesDenmark, Hungary, Poland, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJun 10, 2021
Enrollment StartJun 24, 2021
Primary CompletionApr 28, 2025
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 5.1 years ago

Arms & Interventions

Cohort 1: Participants aged 7-11 yearexperimental

Participants aged 7-11 years will receive nemolizumab for 52 weeks.

Drug: Nemolizumab
Cohort 1.1: Participants aged 7-11 yearsexperimental

Participants aged 7-11 years will receive nemolizumab for 52 weeks.

Drug: Nemolizumab
Cohort 2: Participants aged 2-6 yearsexperimental

Participants aged 2-6 years will receive nemolizumab for 52 weeks.

Drug: Nemolizumab

Interventions

Nemolizumabdrug

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.

Nemolizumabdrug

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.