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New shot could tame severe eczema in kids

NCT ID NCT04921345

Disease control Sponsor: Galderma R&D Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called nemolizumab in 109 children aged 2 to 11 with moderate-to-severe eczema. The drug is given as a shot under the skin every 4 weeks for a year. Researchers measured how the drug moves through the body, its safety, and whether it improves eczema symptoms. The goal is to see if this treatment can help control this chronic skin condition in young children.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nemolizumab (a drug given as a shot under the skin)
What this could lead to
If successful, this could provide a new treatment option for children with hard-to-control eczema, potentially reducing itching and skin inflammation.
What could go wrong
This is a small, early-phase trial (Phase 2) with no placebo group, so results are preliminary. Side effects or lack of clear benefit may limit future use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

109 people

The number who actually took part.

Started

Jun 2021

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Moderate-to-severe atopic dermatitis

Contacts and locations

Locations

  • Galderma Investigational Site #5495

    Rzeszów, 35-055, Poland

  • Galderma Investigational Site #5531

    Szeged, 6720, Hungary

  • Galderma Investigational Site #5570

    Lodz, 90-265, Poland

  • Galderma Investigational Site #5896

    Esplugues de Llobregat, 0850, Spain

  • Galderma Investigational Site #6147

    Budapest, 1036, Hungary

  • Galderma Investigational Site #6218

    Hellerup, 2900, Denmark

  • Galderma Investigational Site #6237

    Ostrowiec Świętokrzyski, 27-400, Poland

  • Galderma Investigational Site #6261

    Wroclaw, 51-685, Poland

  • Galderma Investigational Site #6262

    Warsaw, 02-953, Poland

  • Galderma Investigational Site #78218-3128

    San Antonio, Texas, 78218-3128, United States

  • Galderma Investigational Site #8092

    Louisville, Kentucky, 40217-1444, United States

  • Galderma Investigational Site #8142

    Indianapolis, Indiana, 46250-2041, United States

  • Galderma Investigational Site #8155

    Troy, Michigan, 48084-5260, United States

  • Galderma Investigational Site #8206

    Norman, Oklahoma, 73069-6301, United States

  • Galderma Investigational Site #8242

    Brooklyn, New York, 11203-2012, United States

  • Galderma Investigational Site #8255

    Philadelphia, Pennsylvania, 19103-4708, United States

  • Galderma Investigational Site #8560

    West Bloomfield, Michigan, 48322, United States

  • Galderma Investigational Site #8636

    Fountain Valley, California, 92708-3701, United States

  • Galderma Investigational Site #9929

    Coral Gables, Florida, 92083-6031, United States

  • Galderma Investigational Site #9930

    Vista, California, 92083-6031, United States

  • Galderma Investigational Site #9931

    Beaumont, Texas, 77706-3061, United States

  • Galderma Investigational Site #9937

    San Diego, California, 92123-2746, United States

  • Galderma Investigational Site #9938

    New York, New York, 10032-3729, United States

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