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Evaluating the effects of nemolizumab on moderate-to-severe atopic dermatitis in children

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

Phase 2 Interventional Galderma R&D · NCT04921345

This study is testing a new medication called nemolizumab to see if it can help children aged 2 to 11 with moderate-to-severe eczema feel better and improve their skin condition.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment105 (estimated)
Ages2 Years to 12 Years
SexAll
SponsorGalderma R&D Industry-sponsored
Drugs / interventionsnemolizumab
Locations23 sites (Fountain Valley, California and 22 other locations)
Trial IDNCT04921345 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the pharmacokinetics, safety, and efficacy of nemolizumab in pediatric participants aged 2 to 11 years with moderate-to-severe atopic dermatitis. Participants must have a documented history of chronic atopic dermatitis and meet specific severity criteria. The study will involve administering nemolizumab and monitoring its effects on skin condition and overall safety. The trial will also require participants to adhere to a moisturizer regimen and use topical corticosteroids as directed.

Who should consider this trial

Good fit: Ideal candidates are children aged 2 to 11 years with chronic moderate-to-severe atopic dermatitis who meet specific severity criteria.

Not a fit: Patients with mild atopic dermatitis or those who do not meet the inclusion criteria will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of moderate-to-severe atopic dermatitis in children.

How similar studies have performed: Previous studies on similar biologic treatments for atopic dermatitis have shown promising results, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Chronic AD that has been documented for at least 6 months for participants aged 2-6 years and at least 1 year for participants aged 7-11 years before the screening visit and confirmed according to the American Academy of Dermatology Consensus Criteria at the time of the screening visit
* EASI score \>=16 at both screening and baseline visits
* IGA score \>=3 at both screening and baseline visits
* AD involvement \>=10% of BSA at both screening and baseline visits
* Peak (maximum) PP NRS score of at least 4.0 at both screening and baseline visits
* Agree to apply a moisturizer throughout the study from the screening visit daily, and liberally as needed; agree to apply an authorized topical corticosteroids (TCS) from the screening visit and throughout the study as determined appropriate by the investigator
* Participant and caregiver willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Body weight less than 10 kilogram (kg)
* Child in Care: a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation
* Participants with a current medical history of chronic bronchitis
* Requiring rescue therapy for AD during the run-in period or expected to require rescue therapy within 2 weeks following the baseline visit
* Positive serology results for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), hepatitis C (HCV) antibody with positive confirmatory test for HCV (example; polymerase chain reaction \[PCR\]), or human immunodeficiency virus (HIV) antibody at the screening visit
* History of lymphoproliferative disease, hypersensitivity (including anaphylaxis) to an immunoglobulin product and intolerance to low or mid potency topical corticosteroids
* Known or suspected immunosuppression
* Participants unwilling to refrain from using prohibited medications during the clinical trial.
* Other protocol defined exclusion criteria could apply

Where this trial is running

Fountain Valley, California and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Moderate-to-Severe Atopic DermatitisAtopic DermatitisNemolizumabCD14152
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.