NCT02388971

Proof of Mechanism Study of MLN1202 on Atherosclerotic Inflammation in Participants With Stable Atherosclerotic Cardiovascular Disease

A Randomized, Double-Blind Placebo- Controlled Phase 2a Study to Assess the Effect of CCR2 Antagonism by MLN1202 on Atherosclerotic Inflammation in Subjects With Stable Atherosclerotic Cardiovascular Disease Using FDG PET/CT Imaging

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of MLN1202 on arterial inflammation in participants with stable atherosclerotic cardiovascular disease (CVD) who are receiving standard-of-care (SOC) therapy.

Detailed description

The drug being tested in this study is called MLN1202. MLN1202 is being tested to treat people who have stable atherosclerotic cardiovascular disease (CVD). This study will look at changes in arterial inflammation in people who take MLN1202 in addition to standard-of-care (SOC) therapy. The study will enroll approximately 108 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * MLN1202 Dose A intravenously (IV) * Placebo (dummy inactive solution) - this is a solution that looks like the study drug but has no active ingredient All participants will receive IV administration of MLN1202 or placebo on Day 1, Day 29, and Day 57 of this study. This multi-centre trial will be conducted in the United States. The overall time to participate in this study is 19 weeks. Participants will make 7 visits to the clinic, and will be contacted by telephone approximately 35 days after last dose of study drug for a follow-up assessment.

Conditions

• Atherosclerotic Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	MLN1202	MLN1202 solution
DRUG	Placebo	MLN1202 placebo-matching solution

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-03-17
• Last updated: 2015-12-10