A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease

CompletadoFase 3ClinicalTrials.gov

ID: NCT03105128Tipo: INTERVENTIONALInicio: 10 de may de 2017Fin estimado: 14 de abr de 2021

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).

Elegibilidad

Edad mínima: 16 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Male or female aged \>=18 to \<= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, participants 16 to \< 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
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, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD.
If female, participant must meet the contraception recommendations.

Criterios de exclusión

Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
Participants with unstable doses of concomitant Crohn's disease therapy.
Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within 35 days or 5 half-lives prior to Baseline, whichever is longer.
Prior exposure to p19 inhibitors (e.g., risankizumab).
Complications of Crohn's disease.
Having an ostomy or ileoanal pouch.
Known active Coronavirus Disease 2019 (COVID-19) infection.

Intervenciones

drug

placebo for risankizumab

Placebo for risankizumab administered by intravenous infusion

drug

risankizumab IV

Risankizumab administered by intravenous infusion

drug

risankizumab SC

Risankizumab administered by subcutaneous (SC) injection

Ubicaciones

Duplicate_HOSPITAL CENTENARIO /ID# 170883

Rosario, Santa Fe Province, Argentina

Hospital Privado Univesitario /ID# 161988

Córdoba, Argentina

Patrocinadores

PrincipalAbbVie

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