Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids (SHORE)
Interventional
Phase 3
Sanofi (Voir sur ClinicalTrials)
janvier 2024
décembre 2025
03 mai 2025
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind,
placebo controlled, 3-arm study for treatment of participants diagnosed with
moderate-to-severe atopic dermatitis (AD) with a history of inadequate response of
topical treatment, on background topical corticosteroid (TCS) and/or topical calcineurin
inhibitor (TCI).
The purpose of this study is to measure the efficacy and safety of treatment with
amlitelimab solution for subcutaneous (SC) injection compared with placebo in
participants with moderate to severe AD aged 12 years and older on background TCS and/or
TCI.
Study details include:
At the end of the treatment period, participants will have an option to enter a separate
study: the blinded extension study EFC17600 (ESTUARY).
For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study
duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized
double-blind period, and a 16-week safety follow-up.
For participants entering the blinded extension Study EFC17600 (ESTUARY), the study
duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week
randomized double-blind period.
The total treatment duration will be up to 24 weeks. The total number of visits will be
up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600
(ESTUARY).
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Investigational Site Number : 2500002 - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500006 - 69495 - Pierre-bénite - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500009 - 44093 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500010 - 26102 - Romans-sur-Isère - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500011 - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500012 - 76031 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500013 - 06202 - Nice - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500016 - 97410 - Saint-pierre - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Participants must be 12 years of age (when signing informed consent form)
- Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology
Consensus Criteria)
- Documented history (within 6 months before screening) of inadequate response to
topical treatments, and/or inadequate response to systemic therapies (within 12
months before screening)
- v-IGA-AD of 3 or 4 at baseline visit
- EASI score of 16 or higher at baseline
- AD involvement of 10% or more of BSA at baseline
- Weekly average of daily PP-NRS of ≥ 4 at baseline visit.
- Able and willing to comply with requested study visits and procedures
- Body weight ≥25 kg
- Participants must be 12 years of age (when signing informed consent form)
- Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology
Consensus Criteria)
- Documented history (within 6 months before screening) of inadequate response to
topical treatments, and/or inadequate response to systemic therapies (within 12
months before screening)
- v-IGA-AD of 3 or 4 at baseline visit
- EASI score of 16 or higher at baseline
- AD involvement of 10% or more of BSA at baseline
- Weekly average of daily PP-NRS of ≥ 4 at baseline visit.
- Able and willing to comply with requested study visits and procedures
- Body weight ≥25 kg
Participants are excluded from the study if any of the following criteria apply:
- Skin co-morbidity that would adversely affect the ability to undertake AD
assessments
- Known history of or suspected significant current immunosuppression
- Any malignancies or history of malignancies prior to baseline (with the exception of
non-melanoma skin cancer excised and cured >5 years prior to baseline)
- History of solid organ or stem cell transplant
- Any active or chronic infection including helminthic infection requiring systemic
treatment within 4 weeks prior to baseline
- Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at
screening visit
- Having active tuberculosis (TB), latent TB, a history of incompletely treated TB,
suspected extrapulmonary TB infection, or who are at high risk of contracting TB
- Having received any of the specified therapy within the specified timeframe(s) prior
to the baseline visit
- In the Investigator's opinion, any clinically significant laboratory results or
protocol specified laboratory abnormalities at screening
- History of hypersensitivity or allergy to any of the excipients or investigational
medicinal product (IMP)
The above information is not intended to contain all considerations relevant to a
potential participation in a clinical trial