Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants Aged 6 to 23 Months With Moderate-to Severe Atopic Dermatitis

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Galderma R&D
Study ID
NCT07660835
Phase
PHASE2
Status
Recruiting
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Conditions

  • Moderate-to-Severe Atopic Dermatitis

Eligibility Criteria

Sex
ALL
Age
6 Months - 23 Months
Healthy Volunteers
Not accepted

Interventions

  • Nemolizumab — DRUG
    A lyophilized powder for solution for SC injection.

Study Details

The primary objective of the study is to assess the pharmacokinetics (PK) and safety of nemolizumab in pediatric participants (aged 6-23 months) with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with topical treatments.

Key Dates

First listed
Jun 22, 2026
Start date
Jul 13, 2026
Status verified
Aug 2026
Primary completion
Jul 15, 2028
Completion
Jul 15, 2028

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nemolizumab
    Participants aged 6 to 23 months will receive a subcutaneous (SC) loading dose of nemolizumab high dose on Baseline/Day 1 followed by nemolizumab low dose SC once every 4 weeks (Q4W) for up to 52 weeks (last dose at 48 weeks).

Primary Outcome Measure

Observed Nemolizumab Serum Concentrations [ Time Frame: Predose at Weeks 4, 16, 32 and 52 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Dermatology and Laser Specialist-San AntonioSan AntonioTexas78218-

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By research site
Texas Dermatology and Laser Specialist-San Antonio· San Antonio, TX

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