Resumen

El objetivo principal de este estudio es evaluar la eficacia de lebrikizumab frente a placebo sobre las lesiones cutáneas en participantes adultos y adolescentes con dermatitis atópica de manos y pies. El estudio tiene una duración de hasta 32 semanas, que incluyen un período de selección de 6 semanas, un período de tratamiento de 16 semanas y una visita de seguimiento de seguridad 12 semanas después de la última dosis.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Have an unequivocal diagnosis of chronic atopic hand and/or foot dermatitis at least 1 year prior to screening, regardless of the extent and severity of concomitant atopic dermatitis (AD) on other areas of the body. AD must be present in at least 2 of the 4 mentioned anatomical areas: left hand, right hand, left foot, or right foot at screening and baseline.
Have a Hand Foot - Investigator Global Assessment (HF-IGA) score of 3 or 4 at the screening and baseline visits.
Have a baseline hand and foot peak pruritus (numeric rating scale) NRS score ≥4.
Have a documented history by the investigator of inadequate response to topical medication(s) (topical corticosteroids (TCIs/TCS), topical PDE-4 inhibitors, or topical janus kinase (JAK) inhibitors) in the treatment of atopic hand foot dermatitis (AHFD) within 6 months of screening, or use of topical medications is medically inadvisable (due to intolerance to treatment, hypersensitivity reactions, significant skin atrophy of hand and feet, and systemic effects, as assessed by the investigator or by the treating physician of the participant).
For adolescent participants, body weight ≥40 kilograms (kg) at baseline.

Criterios de exclusión

Have a positive patch test reaction to 1 or more allergens (a score of 1+ or above according to the International Contact Dermatitis Research Group grading scale) before baseline AND which are deemed to be clinically relevant in the view of the investigator as the current cause of the hand and foot dermatitis.
Have a documented diagnosis of allergic contact dermatitis (ACD) of hands and/or feet, and have a positive patch test reaction at screening, regardless of whether the history of current skin exposure to products containing this allergen (current relevance) is present.
Have a documented or strong clinical suspicion of the diagnosis of protein contact dermatitis of hands and/or feet. These are the participants with occupational or nonoccupational contact with proteins such as food, latex, and so on, who have positive prick test results and present with lesions of contact urticaria or dermatitis on hands and feet.
Have a documented exposure to irritants in the occupational or non-occupational (household/recreational) setting that is believed to be a predominant cause of the current hand and foot dermatitis as per the judgment of the investigator.
Presence of skin comorbidities on hand and/or foot that may interfere with study assessments, such as (but not limited to) palmoplantar psoriasis, palmoplantar keratoderma, impetiginized eczema, lichen planus, pityriasis rubra pilaris, herpes simplex, erythema multiforme, tinea, or scabies.
Have skin comorbidities that may interfere with study assessments.
Treatment with topical medications on the hands and feet within 2 weeks before the baseline visit (except for the use of the participant's own emollients).
Prior treatment with interleukin-13 (IL-13) inhibitors such as lebrikizumab or tralokinumab.
Have received any live attenuated vaccine within less than 4 weeks of the baseline visit or intend to receive a live attenuated vaccine during the study, or within 4 weeks after receiving the last dose of study intervention.

Ubicaciones

CONEXA Investigacion Clinica S.A.

Buenos Aires, Argentina

Investigaciones Medicas Imoba Srl

Buenos Aires, Argentina

CIPREC

Buenos Aires, Argentina

Instituto de Neumonologia Y Dermatologia

Buenos Aires, Argentina

Psoriahue

Buenos Aires, Argentina

Fundación Respirar

Buenos Aires, Argentina

Parra Dermatología

Mendoza, Argentina

Fundacion Estudios Clinicos

Rosario, Argentina

INECO Neurociencias Oroño

Rosario, Argentina

Instituto de Investigaciones Clinicas Rosario

Rosario, Argentina

Centro de Investigaciones San Miguel

San Miguel, Argentina

Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia y seguridad de lebrikizumab en participantes adultos y adolescentes con dermatitis atópica moderada a grave de manos y pies

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Lebrikizumab

Placebo

Ubicaciones

CONEXA Investigacion Clinica S.A.

Investigaciones Medicas Imoba Srl

CIPREC

Instituto de Neumonologia Y Dermatologia

Psoriahue

Fundación Respirar

Parra Dermatología

Fundacion Estudios Clinicos

INECO Neurociencias Oroño

Instituto de Investigaciones Clinicas Rosario

Centro de Investigaciones San Miguel

Patrocinadores