Estudio de fase 2b, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y seguridad de tulisokibart en participantes con hidradenitis supurativa moderada a grave

Activo, no reclutaFase 2ClinicalTrials.gov

ID: NCT06956235Tipo: INTERVENTIONALInicio: 9 de jun de 2025Fin estimado: 22 de ene de 2029

Resumen

Este es un estudio de fase 2b aleatorizado, doble ciego, controlado con placebo de la seguridad y eficacia de tulisokibart en participantes con hidradenitis supurativa moderada a grave. La hipótesis principal es que al menos 1 dosis de tulisokibart es superior al placebo en cuanto a la proporción de participantes que alcanzan una reducción del 50 % en la Respuesta Clínica de Hidradenitis Supurativa (HiSCR50) en la Semana 16 (es decir, al final del tratamiento doble ciego).

Descripción detallada

Este estudio consta de un período doble ciego de 16 semanas y una extensión a largo plazo (LTE) de 100 semanas, compuesta por una extensión principal de 40 semanas y una extensión opcional de 60 semanas.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Has signs and symptoms of hidradenitis suppurativa (HS) for ≥6 months prior to Screening and a clinical diagnosis of HS at Screening
Has moderate or severe HS defined as a total combined number of ≥ 5 abscesses and/or inflammatory nodules, with HS lesions present in ≥ 2 distinct anatomical areas and ≥ 1 anatomic area of HS involvement characterized as Hurley Stage II or III
Has a history of inadequate response to a course of systemic antibiotics for treatment of HS or intolerance to or has a contraindication to systemic antibiotics for treatment of HS
Has ≤20 draining tunnel count at Screening and Randomization

Criterios de exclusión

Has other active skin conditions that may, in the judgment of the investigator, interfere with the assessment of HS
Has any immune-mediated inflammatory condition that is not well controlled and which may potentially require biologic therapy
Has a transplanted organ and requires continued systemic immunosuppression
Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years
Has had a diagnostic evaluation suggestive of malignancy (eg, chest or breast imaging) and the possibility of malignancy cannot be reasonably excluded following additional clinical assessments
Has a known infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
Has any active infection
Has active tuberculosis
Has had major surgery within the past 3 months or has a major surgery planned during the study
Has a history of clinically significant drug or alcohol abuse within the past 6 months
Has prior exposure to tulisokibart
Has undergone laser therapy or surgical procedures for their lesions within the past 6 weeks or is planning to have laser therapy or surgical procedures for lesions during participation in the study
Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Intervenciones

drug

Tulisokibart

Solution in autoinjector for subcutaneous (SC) injection

drug

Placebo

Solution in autoinjector for SC injection

Ubicaciones

CIPREC ( Site 0202)

CABA, Argentina

Hospital Italiano de Buenos Aires ( Site 0205)

CABA, Argentina

Psoriahue ( Site 0203)

CABA, Argentina

Derma Internacional SA ( Site 0206)

CABA, Argentina

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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