Caring for patients
with generalized
Myasthenia Gravis?
Consider the NIMBLE Study
Caring for patients
with generalized
Myasthenia Gravis?
Consider the NIMBLE Study
NIMBLE is a study for adults with generalized myasthenia gravis (gMG). This study is evaluating the safety, tolerability, and efficacy of a combination treatment involving two investigational study drugs in adults with gMG.
The investigational study drugs are administered as subcutaneous injections given once a month. The study drugs include:
Pozelimab:
An investigational human monoclonal antibody that blocks your complement component 5 (C5). In people with gMG, the action of C5 damages the communication between nerves and muscles, which disturbs normal muscle contraction.
Combination:
Both pozelimab and cemdisiran for complete suppression of the complement C5 system.
Cemdisiran:
An investigational small interfering RNA (siRNA) therapeutic that suppresses the production of complement proteins (specifically C5) in the liver.
Placebo:
Participants will have approximately a 30% chance of receiving the placebo during the randomized treatment period (first 24 weeks).
After this, all participants will receive active study drugs.
NIMBLE is enrolling approximately 235 people with gMG worldwide.
Patients are expected to participate in this study for approximately 3.5 years.
During the study, participants will visit the study site approximately 25 times ranging from weekly to quarterly.
Participants may also be compensated for travel and accommodation costs.
How can you help?
The success of this study depends on physicians like you to refer potential study participants. Your patients may be eligible if they have been diagnosed with generalized myasthenia gravis and are:
18 years of age or older (or of legal adult age in your country)
Currently experiencing signs and symptoms despite standard
of care treatment
Positive for anti-AChR or anti-LRP4 antibodies
Receiving an acetylcholinesterase inhibitor and an
immunosuppressant drug for gMG (some exceptions may apply)
(Please note: Other protocol-defined inclusion/exclusion criteria apply)
The study team will check your patient’s full medical history to see if they meet all inclusion criteria. To learn more about this study, visit the NIMBLE Study page.
If you have patients who meet the criteria for this clinical study, please discuss the NIMBLE Study with them and contact the nearest clinical site to refer them: Site Finder.
Please remember – your patient’s health and safety are our top priorities.
We hope you see the impact of this research and will consider referring potential candidates. With your support, we hope to better understand how we may be able to help patients with myasthenia gravis.