Programa de desarrollo aleatorizado, multicéntrico, doble ciego y controlado con placebo para evaluar la eficacia y seguridad de LY4268989 (MORF-057) en el tratamiento de adultos con colitis ulcerosa moderadamente a gravemente activa (EMERALD-3)

Aún no reclutaFase 2ClinicalTrials.gov

ID: NCT07415044Tipo: INTERVENTIONALInicio: 1 de abr de 2026Fin estimado: 1 de jul de 2031

Resumen

El propósito principal de este estudio es evaluar la seguridad y eficacia de LY4268989 en comparación con placebo en participantes adultos con colitis ulcerosa (CU) moderadamente a gravemente activa. El medicamento del estudio se administrará por vía oral. El estudio tendrá una duración de aproximadamente 108 semanas, sin incluir el período de selección.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC
Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by central reader and rectal bleeding (RB)≥1
Have evidence of UC extending proximal to the rectum
Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms for more than 8 years
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). Participants with inadequate response to vedolizumab are excluded
Must meet contraception requirements

Criterios de exclusión

Have a current diagnosis of
Crohn's disease
Inflammatory Bowel Disease (IBD unclassified) (formerly known as indeterminate colitis), or
primary sclerosing cholangitis
Have an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation
Have had or will need bowel resection or intestinal or intra-abdominal surgery
Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic
Have any prior or current evidence of cancer gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancies
Have a diagnosis or history of malignant disease within 5 years prior to randomization

Intervenciones

drug

LY4268989

Administered orally

drug

Placebo

Administered orally

Ubicaciones

Stat Research S.A.

Buenos Aires, Argentina

Mautalen Salud e Investigación

Buenos Aires, Argentina

GEDYT

Buenos Aires, Argentina

CER medical Institute

Quilmes, Argentina

EDGARDO DANIEL GIMENEZ

INECO Neurociencias Oroño

Rosario, Argentina

Hospital Provincial del Centenario

Rosario, Argentina

Instituto Médico de Alta Complejidad San Isidro Sa

San Isidro, Argentina

EDGARDO SMECUOL

C.I.C.E. 9 de Julio

San Miguel de Tucumán, Argentina

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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