Resumen

Se trata de un estudio de seguridad a largo plazo de un solo grupo y un brazo para el tratamiento de participantes con dermatitis atópica (DA) de moderada a grave. El objetivo de este estudio es caracterizar la seguridad y eficacia a largo plazo de amlitelimab en participantes tratados con edad ≥12 años con DA de moderada a grave. La duración del estudio por participante será de hasta 284 semanas, incluyendo: * Un período de selección de hasta 2 a 4 semanas * Un período de tratamiento abierto de hasta 268 semanas (aproximadamente 5 años) * Un período de seguimiento de seguridad postratamiento de al menos 20 semanas después de la última administración de dosis (última administración de MI en la Semana 264) El número planificado de visitas será de 35 visitas.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Participant must be at least 12 years of age inclusive, at the time of signing the informed consent.
Participants must have AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at baseline.
Participant must have documented history (within 6 months prior to screening visit), of inadequate response (including inadequate efficacy or medical inadvisability) to topical treatments and/or inadequate response to systemic therapies (within 12 months prior to screening visit).
Eczema Area Severity Index (EASI) of 16 or higher at baseline visit/Visit 2.
Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or 4 at baseline visit/Visit 2.
AD involvement of 10% or more of body surface area (BSA) at baseline visit/Visit 2.
Weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) of ≥ 4 at baseline visit/Visit 2.
Able and willing to comply with requested study visits and procedures.
Body weight must be greater than or equal to 25 kg.
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants must not be pregnant or breastfeeding.

Criterios de exclusión

Skin co-morbidity that would adversely affect the ability to undertake AD assessments as per investigator's judgement
Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to baseline).
History of solid organ or stem cell transplant.
Any pre-planned major elective surgery known about at baseline that in the opinion of the investigator would necessitate that IMP be permanently discontinued or require more than three doses to be missed.
Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study.
Any medical or psychiatric condition which, in the opinion of the Investigator may present an unreasonable risk to the study participants as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments.
Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline (1 week in the event of superficial skin infections); and any infection which as per Investigator's opinion precludes the participant's participation in the study.
Treatment with live (attenuated) vaccines within 12 weeks prior to baseline; failure to complete non-live immunizations required by local regulation (eg, vaccination for COVID-19) at least 14 days prior to baseline.
Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit.
Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at the screening visit.
Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, non-TB mycobacterial infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening.
In the Investigator's opinion, any clinically significant laboratory results from the clinical chemistry, hematology, coagulation, or urinalysis tests at the screening visit.
In the Investigator's opinion, any significant abnormality on 12-lead electrocardiogram (ECG) at the screening visit that could be suggestive of an unstable or underlying cardio-vascular condition that could preclude the participant's participation in the study.
History of hypersensitivity or allergy to any of the excipients or IMP or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Ubicaciones

Investigational Site Number : 0320022

General Pico, La Pampa Province, Argentina

ACTIVE_NOT_RECRUITING

Investigational Site Number : 0320006

Rosario, Santa Fe Province, Argentina

ACTIVE_NOT_RECRUITING

Investigational Site Number : 0320007

Rosario, Santa Fe Province, Argentina

ACTIVE_NOT_RECRUITING

Investigational Site Number : 0320008

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Investigational Site Number : 0320001

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Investigational Site Number : 0320003

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Investigational Site Number : 0320002

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Investigational Site Number : 0320004

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Investigational Site Number : 0320009

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Investigational Site Number : 0320005

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Un Estudio Abierto, Multinacional, Multicéntrico para Evaluar la Seguridad, Tolerabilidad y Eficacia a Largo Plazo de amlitelimab Subcutáneo en Participantes de 12 Años o Más con Dermatitis Atópica de Moderada a Grave

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Amlitelimab

Ubicaciones

Investigational Site Number : 0320022

Investigational Site Number : 0320006

Investigational Site Number : 0320007

Investigational Site Number : 0320008

Investigational Site Number : 0320001

Investigational Site Number : 0320003

Investigational Site Number : 0320002

Investigational Site Number : 0320004

Investigational Site Number : 0320009

Investigational Site Number : 0320005

Patrocinadores

Contactos

Trial Transparency email recommended (Toll free number for US & Canada)