Long-term open-label study evaluating the safety and efficacy of subcutaneous amlitelimab in participants aged 12 and over with moderate-to-severe atopic dermatitis (ATLANTIS)
Topic / Pathology
- Biologic
- interventional
Objectives
Single-arm, single-arm, long-term safety study for the treatment of participants with moderate-to-severe atopic dermatitis (AD), with the objective of characterizing the long-term safety and efficacy of amlitelimab in treated adults with moderate-to-severe AD.
The duration of the study per participant will be 180 weeks, including :
a maximum 2- to 4-week screening period
an open-label treatment period of up to 160 weeks (approximately 3 years)
A post-treatment safety follow-up period of up to 20 weeks after the last dose.
https://clinicaltrials.gov/study/NCT05769777?term=NCT05769777&rank=1
Sponsor
Sanofi
Investigator
Pr Delphine Staumont
Critères d'inclusion
- Participants must have had atopic dermatitis, as defined by the American Academy of Dermatology consensus criteria, for at least one year at the time of initial evaluation.
- Participants must have a documented history, within 6 months prior to the screening visit, of inadequate response or inappropriateness of topical treatments.
- Eczema Severity Index (EASI) of 16 or more at baseline visit.
- Investigator-validated Global AD Assessment Scale (vIGA-AD) of 3 or 4 at baseline.
- AD on 10% or more of body surface area (BSA) at baseline.
- Weekly mean pruritus numerical rating scale (PP-NRS) of ≥ 4 at baseline.
Critères de non-inclusion
- Skin co-morbidity that would adversely affect the ability to undertake AD assessments, as judged by the investigator.
- Known history of immunosuppression or suspicion of current significant immunosuppression
- Any malignancy or history of malignancy prior to study entry (with the exception of non-melanoma skin cancer that has been excised and completely healed for more than 5 years prior to study entry).
- History of solid organ or stem cell transplantation.
- Any major elective surgery planned and known at the start of the study which, in the opinion of the investigator, would require permanent discontinuation of IMP or omission of more than three doses.
- Serious concomitant disease which, in the opinion of the investigator, would prevent the participant from taking part in the study.
- Treatment with live (attenuated) vaccines within 12 weeks prior to study start; inability to complete non-living vaccinations required by local regulations (e.g. COVID-19 vaccination) at least 14 days prior to study start.
- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at screening visit.
- Participants with active tuberculosis, latent tuberculosis or a history of incompletely treated tuberculosis.
- Other exclusion criteria apply.
Status
Ongoing
