Overview

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

Status:
Recruiting
Trial end date:
2023-09-30
Target enrollment:
0
Participant gender:
All
Summary
Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Galderma R&D
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