NCT02574637|TerminatedPhase 2ResultsDMCFDA Drug

Study Stopped

Study was terminated for business reasons; not due to safety or efficacy concerns.

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

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

AstraZeneca ClinicalTrials.gov

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2 other identifiers

D5170C000022015-000609-38

Study Type

interventional

Target

Locations

12 countries

Sites

Timeline

RegisteredOct 2015

StartedJan 2016

CompletionJan 2018

Brief Summary

A Phase 2b study to evaluate the efficacy and safety of brazikumab (MEDI2070) in participants with moderate to severe Crohn's disease who have failed or are intolerant to anti-tumor necrosis factor-alpha (anti-TNFα) therapy.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Jan 2016

Geographic Reach

12 countries

97 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

First Submitted

Initial submission to the registry

September 24, 2015

Completed

20 days until next milestone

First Posted

Study publicly available on registry

October 14, 2015

Completed

3 months until next milestone

Study Start

First participant enrolled

January 5, 2016

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2017

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2018

Completed

2.3 years until next milestone

Results Posted

Study results publicly available

May 15, 2020

Completed

Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

1.6 years

First QC Date

September 24, 2015

Results QC Date

May 1, 2020

Last Update Submit

May 6, 2021

Conditions

Crohn's Disease

Keywords

MEDI2070inflammatory bowel diseasemoderate to severe Crohn's DiseaseIL-23

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Remission at Week 8
CDAI remission was defined as a CDAI score of \<150 at Week 8. CDAI score was calculated by summing weighted scores for subjective items \[number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)\] recorded by a diary during a 1-week period, and objective items \[associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight\]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Week 8

Secondary Outcomes (16)

Percentage of Participants With Loose/Liquid Stool Frequency Response
Baseline, Weeks 8, 16 and 28
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response
Baseline, Weeks 8, 16 and 28
Percentage of Participants With CDAI Clinical Remission
Weeks 16 and 28
Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) Response
Baseline, Weeks 16 and 28
Percentage of Participants With Loose/Liquid Stool Frequency Remission
Baseline, Weeks 8, 16 and 28
+11 more secondary outcomes

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.