Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

Galderma

Status and phase: Active, not recruiting; Phase 3

Conditions: Moderate-to-Severe Atopic Dermatitis

Treatments: Drug: Nemolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03989206

RD.06.SPR.118163

Details and patient eligibility

About

Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description

Full description

Long-term study to assess the safety and efficacy of nemolizumab in subjects with moderate-to-severe AD

Enrollment: 1,700 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior nemolizumab study for AD
2. Female subjects of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, 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:

1. Subjects who, during their participation in a prior nemolizumab study, experienced an AE which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the subject.
2. Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study.
3. Body weight < 30 kg
4. Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit. Subjects may be rescreened once the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods.
5. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody)
6. Any clinically significant issue, based investigator judgement

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,700 participants in 1 patient group

Nemolizumab

Experimental group

Description:

Nemolizumab administered via subcutaneous injection

Treatment:

Drug: Nemolizumab