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Ensayo de amlitelimab mediante inyección subcutánea en participantes de 12 años de edad y mayores con dermatitis atópica de moderada a severa que reciben tratamiento de base con corticoides tópicos.
THE STUDY IS CALLED EFC17561 (SHORE) AND AIMS TO EVALUATE A NEW EXPERIMENTAL DRUG, SAR445229, CALLED AMLITELIMAB, FOR THE TREATMENT OF MODERATE TO SEVERE AD. ATOPIC DERMATITIS (AD), ALSO KNOWN AS ATOPIC ECZEMA, IS A SEVERE SKIN DISORDER THAT CAUSES ITCHING AND RED PATCHES, USUALLY ON THE FACE, ARMS AND LEGS, WHICH CAN AFFECT YOUR HEALTH, SOCIAL FUNCTIONING, PSYCHOLOGICAL WELL-BEING AND QUALITY OF LIFE. YOU ARE ELIGIBLE IF YOU HAVE BEEN DIAGNOSED WITH MODERATE TO SEVERE AD AT LEAST ONE YEAR PRIOR AND HAVE USED TOPICAL CORTICOSTEROIDS OR TOPICAL CALCINEURIN INHIBITORS WITHOUT ADEQUATE BENEFIT FROM TOPICAL MEDICATIONS IN THE PAST 6 MONTHS OR HAVE USED SYSTEMIC TREATMENTS FOR AD WITHOUT ADEQUATE BENEFIT IN THE PAST 12 MONTHS.
Technical Summary
- PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, 3-TREATMENT ARM, MULTINATIONAL, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AMLITELIMAB BY SUBCUTANEOUS INJECTION IN PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS RECEIVING BASELINE TOPICAL CORTICOSTEROID THERAPY
- Code EudraCT: 2023-506558-20
- Protocol number: EFC17561
- Promoter: Sanofi-Aventis S.A.
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* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
Who can participate?
Trial of amlitelimab by subcutaneous injection in participants 12 years of age and older with moderate to severe atopic dermatitis receiving baseline treatment with topical corticosteroids
More information about this clinical trial
Information offered by the Spanish Registry of Clinical Studies
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