An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination With Mirikizumab for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis

ReclutandoFase 2ClinicalTrials.gov

ID: NCT06598943Tipo: INTERVENTIONALInicio: 10 de oct de 2024Fin estimado: 1 de sept de 2028

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).

Descripción detallada

The study will last approximately 4-5 years. Screening is required within 35 days prior to enrollment. For each participant, the total duration of the clinical trial will be about 69 weeks including screening.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Have had an established diagnosis of UC of ≥3 months in duration before baseline.
Have moderately to severely active UC as assessed by the UC disease activity score.
Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators).
Are on a stable dose of certain oral UC medications (including corticosteroids).
Must meet contraception requirements.

Criterios de exclusión

Have received anti-interleukin (IL)-23p19 or anti-IL-12p40 antibodies in the past.
Have experienced a thrombotic event within 24 weeks before baseline.
Have a current diagnosis of Crohn's Disease or certain other inflammatory gastrointestinal diseases.
Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study.
Have a history of certain adenomas, dysplasia's, or malignancies.

Intervenciones

drug

Eltrekibart

Administered

drug

Mirikizumab

Administered

drug

Placebo

Administered

Ubicaciones

CIPREC

CABA, Argentina

RECRUITING

Mautalen Salud e Investigacion-Centro de Osteopatías Médicas

Ciudad Autonoma de Buenos Air, Argentina

RECRUITING

Clínica Privada Independencia

Munro, Argentina

NOT_YET_RECRUITING

CER Instituto Medico

Quilmes, Argentina

NOT_YET_RECRUITING

Hospital Provincial del Centenario

Rosario, Argentina

RECRUITING

Centro Medico Privado de Reumatologia

SAN M. de Tucuman, Argentina

RECRUITING

Patrocinadores

PrincipalEli Lilly and Company

Contactos

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

LillyTrials@Lilly.com 1-317-615-4559

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

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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