Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants with Active, Moderate to Severe Crohn’s Disease

Study identifier:D5170C00002

ClinicalTrials.gov identifier:NCT02574637

EudraCT identifier:2015-000609-38

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A Phase 2b Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

Medical condition

Crohn's disease

Phase

Phase 2

Healthy volunteers

No

Study drug

Brazikumab IV Infusion, Brazikumab IV Infusion, Brazikumab IV Infusion, Brazikumab IV Infusion, Brazikumab IV Infusion, Brazikumab SC Injection, Brazikumab SC Injection, Brazikumab SC Injection, Brazikumab SC Injection, Brazikumab SC Injection, Placebo, Placebo, Placebo, Placebo, Placebo

Sex

All

Actual enrollment

29

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 05 Jan 2016
Primary Completion Date: 28 Jul 2017
Study Completion Date: 29 Jan 2018

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 May 2021 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria