Resumen

Este es un estudio de fase 2, multinacional, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y 3 brazos, para investigar la eficacia y seguridad de las inyecciones subcutáneas (SC) de amlitelimab en monoterapia en participantes de 18 años o más con alopecia areata (AA) grave. Al finalizar el período de tratamiento doble ciego, todos los participantes tendrán la opción de ingresar al período de extensión abierta (OLE, por sus siglas en inglés). La duración del estudio será de hasta 160 semanas para los participantes que ingresen al período OLE, incluyendo una selección de 2 a 4 semanas, un período aleatorizado doble ciego de 36 semanas, un período OLE opcional (104 semanas) y un seguimiento de seguridad de 16 semanas. El período de extensión abierta es opcional y está disponible para todos los participantes que hayan completado el período de tratamiento doble ciego. El número total de visitas será de hasta 38 (o 12 visitas para quienes no ingresen al estudio OLE).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Definitive diagnosis of AA of more than 6 months.
Diagnosis of severe AA, as determined by all of the following:
Hair loss affecting ≥50% of the scalp, as measured by Severity of Alopecia Tool (SALT) at both screening and baseline visits.
Current episode of severe hair loss of less than 8 years. Participants with a history of AA of more than 8 years who have observed episodes of terminal hair regrowth over their scalp ("moving patches" spontaneously or following treatment) in the past 8 years can be included.
Stable disease: no evidence of terminal hair regrowth within 6 months (less than 10% improvement over the past 6 months). (guidance: if participant reports to have quite a bit more hair than 6 months prior, then patient cannot be included).
Willingness in maintaining a consistent hair style and hair care, including hair products, and to refrain from weaves, extensions, adhesive wigs, other than banded perimeter devices, refrain from shaving of scalp hair for 2 weeks prior to each study visit from baseline to the end of study.

Criterios de exclusión

Participants are excluded from the study if any of the following criteria apply:
Participants that are currently experiencing other forms of alopecia, including but not limited to: androgenetic alopecia, trichotillomania, telogen effluvium, traction alopecia, scarring alopecia.
Participants currently with any local or systemic active medical conditions, which in the opinion of the Investigator would interfere with evaluations of the IMP effect on AA due to scalp inflammation, including but not limited to seborrheic dermatitis requiring topical treatment to the scalp, lupus erythematosus, lichen planus, psoriasis, secondary syphilis, tinea capitis, thyroiditis, systemic sclerosis, hair transplants, micropigmentation/tattoo of the scalp.
Received the specified treatment regimens within the timeframe outlined in the protocol.
Prior use of any oral JAKi or the topical JAKi ruxolitinib for more than 24 months, regardless if washout period is respected.
Participants with shaved heads must not enter the study until hair has grown back and SALT score can be reliably administered.
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Intervenciones

drug

Amlitelimab

Pharmaceutical form: Injection solution Route of administration: SC injection

drug

Placebo

Pharmaceutical form: Injection solution Route of administration: SC injection

Ubicaciones

Investigational Site Number : 0320002

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320004

Buenos Aires, Argentina

Investigational Site Number : 0320001

Buenos Aires, Argentina

Patrocinadores

PrincipalSanofi