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

CompletadoFase 3ClinicalTrials.gov

ID: NCT03104413Tipo: INTERVENTIONALInicio: 18 de dic de 2017Fin estimado: 19 de may de 2021

Traducción no disponible, mostrando original

Resumen

The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active 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.
Confirmed diagnosis of CD for at least 3 months prior to Baseline.
Crohn's disease activity index (CDAI) score 220 - 450 at 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 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 minimally 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 IV

placebo for risankizumab administered as intravenous (IV) infusion.

drug

risankizumab SC

risankizumab administered by subcutaneous (SC) injection

drug

risankizumab IV

risankizumab administered as intravenous (IV) infusion.

Ubicaciones

Hospital Britanico de Buenos Aires /ID# 168081

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

Cemic /Id# 168082

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

Hospital Provincial del Centenario /ID# 170904

Rosario, Santa Fe Province, Argentina

Hospital Privado Univesitario /ID# 168080

Córdoba, Argentina

Patrocinadores

PrincipalAbbVie

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