A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Moderate-to-Severe Atopic Dermatitis

Purpose:

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

Study summary:

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

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

Study is Available At:

Original ID:

RD.06.SPR.118163

NCT ID:

NCT03989206

Secondary ID:

Study Acronym:

Brief Title:

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

Official Title:

A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Moderate-to-Severe Atopic Dermatitis

ClinicalTrials.gov Link:

https://clinicaltrials.gov/show/NCT03989206

Overall Status:

Enrolling by invitation

Study Phase:

Phase 3

Genders:

N/A

Minimum Age:

12 Years

Maximum Age:

N/A

Study Source:

Galderma R&D

Oversight Authority:

There was an error processing this request

Reasons Why Stopped:

Study Type:

Interventional

Study Design:

Number of Arms:

1

Number of Groups:

0

Total Enrollment:

1700

Enrollment Type:

Anticipated

Data Source: ClinicalTrials.gov

Date Processed: February 03, 2023

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