A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

ReclutandoFase 3ClinicalTrials.gov

ID: NCT07196722Tipo: INTERVENTIONALInicio: 3 de oct de 2025Fin estimado: 6 de oct de 2032

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD
Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score \>=220 but \<=450 and either mean daily SF count \>=4, or mean daily AP score \>=2
Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD \>= 6 for participants with colonic or ileocolonic disease, and SES-CD \>= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments
A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-hCG) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests
Demonstrated an inadequate response to, or failure to tolerate conventional therapy but naïve to advanced therapies (advanced drug therapy \[ADT\]-naïve) or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and/or advanced oral agents for the treatment of CD- (ADT-inadequate responder \[IR\]) as defined in the protocol

Criterios de exclusión

Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention
Presence of a stoma or ostomy
Participants with presence of active fistulas may be included if there is no surgery needed
Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline
Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization

Intervenciones

drug

Icotrokinra

Icotrokinra will be administered orally, daily.

drug

Placebo

Matching placebo will be administered orally, daily.

Ubicaciones

GEDYT

AAI, Argentina

RECRUITING

Hospital Britanico de Buenos Aires

CABA, Argentina

RECRUITING

Clinica Universitaria Reina Fabiola

Córdoba, Argentina

RECRUITING

Hospital Privado de Cordoba

Córdoba, Argentina

RECRUITING

Sanatorio Maipu

Maipú, Argentina

RECRUITING

HIGEA

Mendoza, Argentina

RECRUITING

Patrocinadores

PrincipalJanssen Research & Development, LLC

Contactos

Study Contact

CONTACT

Participate-In-This-Study1@its.jnj.com 844-434-4210

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