Study of an Investigational Drug, RO7239361 (BMS-986089), in Ambulatory Boys With DMD



Status:Active, not recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:5 - 10
Updated:11/7/2018
Start Date:December 2, 2015
End Date:June 29, 2022

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Trial Summary
Trial Overview
Inclusion Criteria

A Multi-Site, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7239361 (BMS-986089) in Ambulatory Boys With Duchenne Muscular Dystrophy

The purpose of this study is to determine the safety and tolerability of RO7239361 in boys
with Duchenne Muscular Dystrophy with any genetic mutation.


Inclusion Criteria:

- Diagnosed with DMD

- Able to walk without assistance

- Able to walk up 4 stairs in 8 seconds or less

- Weigh at least 15 kg

- Taking corticosteroids for DMD

Exclusion Criteria:

- Ejection fraction < 55% on echocardiogram, based on central read

- Any behavior or mental issue that will affect the ability to complete the required
study procedures

- Previously or currently taking medications like androgens or human growth hormone

- Use of a ventilator during the day

- Unable to have blood samples collected or receive an injection under the skin
We found this trial at
11
sites
Saint Louis Children's Hospital
Saint Louis, Missouri 63110
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Saint Louis, MO
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Kennedy Krieger Institute
707 North Broadway
Baltimore, Maryland 21205
443-923-9200
Kennedy Krieger Institute While not officially part of Johns Hopkins Medicine, Kennedy Krieger Institute is...
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Baltimore, MD
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Cincinnati Children's Hospital Medical Center
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Phone: 513-636-8967
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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University of Florida
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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Children's Healthcare of Atlanta
1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Phone: 404-785-9893
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Atlanta, GA
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Alberta Children's Hospital
Calgary, Alberta
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Calgary,
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Rush University Medical Center
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Phone: 312-942-0079
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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University of Kansas Medical Center
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Phone: 913-588-5703
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Kansas City, KS
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David Geffen School of Medicine, UCLA
10833 Le Conte Ave
Los Angeles, California 90095
(310) 825-4321
David Geffen School of Medicine, UCLA In 2002 Mr. David Geffen announced a $200 million...
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Los Angeles, CA
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Nemours Children's Hospital
13535 Nemours Parkway
Orlando, Florida 32827
(407) 567-4000
Phone: 407-650-7964
Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...
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Orlando, FL
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Stanford University
Palo Alto, California 94304
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Palo Alto, CA
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