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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Galderma Investigational Site #8636
  Fountain Valley, California, United States Recruiting
• Galderma Investigational Site #9937
  San Diego, California, United States Recruiting
• Galderma Investigational Site #9930
  Vista, California, United States Recruiting
• Galderma Investigational Site #9929
  Coral Gables, Florida, United States Recruiting
• Galderma Investigational Site #8142
  Indianapolis, Indiana, United States Recruiting
• Galderma Investigational Site #8092
  Louisville, Kentucky, United States Recruiting

Study contacts

• Study coordinator: Galderma Research & Development
• Email: clinical.studies@galderma.com
• Phone: 817-961-5000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nemolizumab for infants with moderate-to-severe atopic dermatitis

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• Nemolizumab vs placebo in Chinese teens and adults with moderate-to-severe atopic dermatitis

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• Skin structure in atopic dermatitis patients treated with nemolizumab assessed by reflectance confocal microscopy

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  Recruiting Hôpitaux Drôme Nord · Romans-sur-Isère, Drôme · NCT07730788

• A Phase 3 test of Rezpegaldesleukin (NKTR-358) for moderate-to-severe atopic dermatitis in patients 12 years and older

  This Phase 3 study tests whether Rezpegaldesleukin helps people aged 12 and up with moderate-to-severe atopic dermatitis compared to placebo.

  Recruiting at 13 sites Phase 3 Nektar Therapeutics · Birmingham, Alabama and 12 other locations · NCT07711418

• Rezpegaldesleukin for moderate-to-severe atopic dermatitis in people 12 and older

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  Recruiting at 20 sites Phase 3 Nektar Therapeutics · Phoenix, Arizona and 19 other locations · NCT07690371

• SYX-5219 in healthy adults and adults with moderate-to-severe atopic dermatitis

  This trial will test oral SYX-5219 in healthy adults and in adults with moderate-to-severe atopic dermatitis to see if it is safe, well tolerated, and how the drug is processed in the body.

  Recruiting at 12 sites Phase 1 Sitryx Therapeutics Ltd · Arkansas City, Arkansas and 13 other locations · NCT07558668

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.