BMS-986089/RG6206 - Bristol-Myers Squibb/Roche Investigational Candidate for Myostatin Inhibition

 

Frequently Asked Questions (FAQs) about this research:

  

What stage is this research?

  • BMS-986089/RG6206 is in a Phase 2/3 clinical trial in ambulatory boys with Duchenne Muscular Dystrophy that is actively recruiting.

 

What is BMS-986089/RG6206 ?

  • BMS-986089/RG6206  is an investigational Glossary Link protein that is designed to bind to myostatin. Myostatin is a protein produced primarily in skeletal muscle cells that prevents muscle cell growth and differentiation. Animals lacking myostatin or animals treated with substances that block the activity of myostatin have larger and stronger muscles.

 

What is the goal or purpose of this research?

  • The primary goal of the Phase 2/3 study is to determine whether this investigational drug (BMS-986089/RG6206) may be a safe and effective treatment for ambulatory boys with Duchenne.

 

Is this research only being carried out in the US?

  • This research is being conducted in the United States, Canada and other countries.
  • Information regarding study sites can be found on the BMS DMD clinical trial patient and caregiver page, BMStrialDMD.com.
  • There are multiple study sites open in the following states: CA, FL, GA, IL, KS, MD, MO, NY, OH, PA, Washington DC, and Canada.

 

Who is eligible to participate in this clinical trial?

  • Boys are eligible to participate if they have Duchenne confirmed by medical history with genetic testing and are:

6 to 11 years of age
• Able to walk without assistance and climb stairs on his own
• Receiving corticosteroids for 6 months (and were on a stable dose for at least 3 months) prior to study participation
• Not diagnosed with kidney disease or heart failure

  • Note that ALL DMD mutations are eligible.
  • Full eligibility requirements for this study will be assessed at participating study sites. For more information on additional criteria, please visit clinicaltrials.gov (NCT#03039686).

  

How many boys will be enrolled in the trial and will they have access to the study drug once the study has ended?

  • Approximately 159 boys with Duchenne will be enrolled in this study.
  • The study consists of an initial 48 week randomized placebo-controlled phase during which all boys will receive the investigational drug (BMS-986089/RG6206 ) or placebo (2:1 ratio, twice as many participants will receive the investigation drug compared to those that receive placebo), administered weekly by a subcutaneous (SC) injection.
  • This phase will be followed by a 48 week open-label phase during which all boys will receive the investigational drug (BMS-986089/RG6206 ).

  

Where can I learn more about this research?

 

(Updated 12/18/2017)