A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

CompletadoFase 3ClinicalTrials.gov

ID: NCT03345836Tipo: INTERVENTIONALInicio: 29 de nov de 2017Fin estimado: 11 de ago de 2021

Traducción no disponible, mostrando original

Resumen

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Confirmed diagnosis of CD for at least 3 months prior to Baseline.
Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
Demonstrated an inadequate response or intolerance to any biologic therapy for infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.
If female, participant must meet the contraception recommendations.

Criterios de exclusión

Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).
Participant with the following ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
Participant with ostomy or ileoanal pouch.
Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome.
Screening laboratory and other protocol pre-specified analyses show abnormal results.

Intervenciones

drug

Matching Placebo for Upadacitinib

Matching placebo tablets

drug

Upadacitinib

Upadacitinib tablets

Ubicaciones

Cardio Alem /ID# 211284

San Isidro, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires /ID# 215543

Ciudad Autonoma Buenos Aires, Ciuadad Autonoma de Buenos Aires, Argentina

Gedyt /ID# 210019

Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina

Cemic /Id# 169184

Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina

Hospital Provincial del Centenario /ID# 171254

Rosario, Santa Fe Province, Argentina

Hospital Privado Univesitario /ID# 169228

Córdoba, Argentina

Patrocinadores

PrincipalAbbVie

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