Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group study for the treatment of participants diagnosed with moderate to severe AD on a TSS background
Topic / Pathology
- Biologic
- interventional
- Paediatric
Objectives
Study to evaluate the efficacy and safety of subcutaneous amlitelimab as part of background treatment with topical corticosteroids in participants aged 12 and over with moderate-to-severe atopic dermatitis who have had an inadequate response to prior biologic therapy or a JAK inhibitor.
The objective of this study is to measure the efficacy and safety of amlitelimab (SC injection) versus placebo in participants with moderate-to-severe AD, aged 12 and over, receiving background therapy with TCS and having had an inadequate response to prior biologic therapy or oral JAKi.
At the end of the treatment period, participants will have the opportunity to enter the long-term safety study LTS17367 (RIVER-AD).
The study will last up to 56 weeks for participants not enrolled in the long-term safety study (LTS17367 [RIVER-AD]), and will include a 2- to 4-week screening, a 36-week double-blind randomized period (including 13 visits) and a 16-week safety follow-up.
https://clinicaltrials.gov/study/NCT06241118?term=NCT06241118&rank
Sponsor
Sanofi
Investigator
Pr Delphine Staumont
Critères d'inclusion
- Diagnosis of AD for at least 1 year (as defined by AAD consensus criteria)
- Documented history, prior to screening visit, of inadequate response to AD biologic medication or oral JAKi therapy.
- v-IGA-AD of 3 or 4 at baseline visit
- EASI score of 16 or more at baseline visit
- AD involvement of 10% or more of body surface area at baseline.
- Weekly mean daily PP-NRS ≥ 4 at baseline visit.
- Body weight ≥25 kg
Critères de non-inclusion
- Skin co-morbidity that would adversely affect ability to undertake AD assessments
- 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 excised and cured > 5 years prior to study entry).
- History of solid organ or stem cell transplantation
- Any active or chronic infection, including helminthic infection requiring systemic treatment within 4 weeks prior to baseline study.
- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at screening visit.
- Active tuberculosis, latent tuberculosis, history of incompletely treated tuberculosis, suspicion of extrapulmonary tuberculosis infection or high risk of contracting tuberculosis.
- Have received one of the specified therapies within the specified time frame(s) prior to the baseline visit.
- In the opinion of the investigator, any clinically significant laboratory findings or laboratory abnormalities specified by the protocol at screening.
- History of hypersensitivity or allergy to any of the excipients or to an investigational drug.
- The above information is not intended to contain all considerations for potential participation in a clinical tr
Status
Ongoing
