A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

CompletadoFase 3ClinicalTrials.gov

ID: NCT02435992Tipo: INTERVENTIONALInicio: 17 de jun de 2015Fin estimado: 17 de jun de 2020

Gastroenterología

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).

Descripción detallada

The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort 2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1 and 2 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Aged 18 to 75 years (at screening for Cohort 1 and 2)
UC confirmed on endoscopy
Moderately to severely active UC (May score 6-12)
Currently receiving treatment with aminosalisylate, prednisone, or budesonide
Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization

Criterios de exclusión

Have severe extensive colitis as evidence by:
Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.
Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation.
Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, radiation colitis, or ischemic colitis
Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
History of uveitis or unknown macular edema
Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening

Intervenciones

drug

RPC1063

drug

Placebo

Ubicaciones

Hospital Italiano

Buenos Aires, Argentina

Instituto DAMIC Fundacion Rusculleda

Córdoba, Argentina

Hospital Italiano de La Plata

La Plata, Argentina

Instituto Medico CER

Quilmes, Argentina

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, Argentina

Patrocinadores

PrincipalCelgene

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