A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)

Galderma

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Biological: Nemolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03921411

RD.06.SPR.116912

Details and patient eligibility

About

The purpose of this study was to evaluate the pharmacokinetics and safety of nemolizumab in adolescent participants with AD.

Enrollment: 20 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

• Male or female participants ≥ 12 to < 17 years of age
• Chronic AD that has been documented for at least 2 years
• Eczema Area and Severity Index (EASI) score ≥ 16
• Investigator's Global Assessment (IGA) score ≥ 3
• AD involvement ≥ 10% of Body Surface Area (BSA)
• Documented recent history of inadequate response to topical medications
• Women of childbearing potential must agree to be strictly abstinent or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.

Key Exclusion Criteria

• Body weight < 30 kilogram (kg)
• Cutaneous infection within 1 week or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week
• History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, example., monoclonal antibody)
• Any medical or psychological condition, or any clinically relevant laboratory abnormalities that may have put the subject at significant risk according to the investigator's judgment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Nemolizumab

Experimental group

Description:

Nemolizumab

Treatment:

Biological: Nemolizumab