A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohns Disease
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase III
PATOLOGÍA
Trombosis y Anticoagulantes, Linfoma
CENTRO INVESTIGADOR
H.U. 12 de Octubre
INVESTIGADOR PRINCIPAL
Yago Gónzalez Lama
FECHA DE APERTURA
Febrero, 2026
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
Participants aged 18 and 80 years of age at Screening. Where permitted locally, participants 16 to <18 years of age who meet the definition of Tanner Stage 5 for development
Confirmed diagnosis of moderately to severely active Crohns Disease (CD) for at least 3 months prior to baseline
Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)
Confirmed diagnosis of moderately to severely active Crohns Disease (CD) for at least 3 months prior to baseline
Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)
CRITERIOS DE EXCLUSIÓN
Participants with Ulcerative Colitis (UC) or indeterminate colitis
Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum
Prior or current high-grade gastrointestinal (GI) dysplasia
Participants on treatment with but not on stable doses of conventional therapy prior to baseline
Participants receiving prohibited medications or therapies
Participants with previous exposure to anti-TL1A investigational therapy
Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum
Prior or current high-grade gastrointestinal (GI) dysplasia
Participants on treatment with but not on stable doses of conventional therapy prior to baseline
Participants receiving prohibited medications or therapies
Participants with previous exposure to anti-TL1A investigational therapy
DESCRIPCIÓN
Sub-Study 2: To assess the efficacy of duvakitug as induction therapy in participants with moderately to severely active CD compared with placebo.
PALABRAS CLAVE
antagonistas de la vitamin k, vitamin k antagonist
