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

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Galderma

Status and phase

Enrolling
Phase 2

Conditions

Moderate-to-Severe Atopic Dermatitis

Treatments

Drug: Nemolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04921345
RD.06.SPR.118126

Details and patient eligibility

About

The purpose of this study is to assess the pharmacokinetics (PK), efficacy, and safety of nemolizumab in pediatric participants with moderate-to-severe atopic dermatitis (AD).

Enrollment

105 estimated patients

Sex

All

Ages

2 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

105 participants in 3 patient groups

Cohort 1: Participants aged 7-11 years
Experimental group
Description:
Participants aged 7-11 years will receive nemolizumab for 52 weeks.
Treatment:
Drug: Nemolizumab
Cohort 1.1: Participants aged 7-11 years
Experimental group
Description:
Participants aged 7-11 years will receive nemolizumab for 52 weeks.
Treatment:
Drug: Nemolizumab
Cohort 2: Participants aged 2-6 years
Experimental group
Description:
Participants aged 2-6 years will receive nemolizumab for 52 weeks.
Treatment:
Drug: Nemolizumab

Trial contacts and locations

23

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Central trial contact

Galderma Research & Development

Data sourced from clinicaltrials.gov

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