Clinical Research Opportunity: Phase 3 Study of Cladribine in People with Generalized Myasthenia Gravis (gMG)

Researchers at EMD Serono Research & Development Institute, Inc. are working to better understand generalized myasthenia gravis (gMG) and study effectiveness of a potentially new treatment.

The study

People who have generalized myasthenia gravis (gMG) may be eligible to participate in a phase 3 clinical trial to evaluate the safety and efficacy of the investigational therapy cladribine to treat gMG. Cladribine is designed to recognize and remove some types of immune cells that do not work properly in people with gMG. It is being evaluated for the ability to improve MG signs and symptoms, as well as the ability to carry out activities of daily living in people with gMG.

This is a phase 3, randomized, double-blind, placebo-controlled study, which means that participants will be randomly assigned to receive the drug or an inactive placebo control. The study will be approximately 3 years in duration, divided into three periods. In periods 1 and 2, participants will attend site visits every 4 weeks with telehealth calls between visits, for a total of 27 visits and calls. In period 3, participants will have site visits every 12 weeks, with two telehealth calls in between each site visit, for a total of 23 visits and calls.

The drug will be administered orally (by mouth). The effects of cladribine will be evaluated using a number of tests and procedures including but not limited to: physical examination, clinical assessments, blood tests, pregnancy tests, assessment of vital signs, and health-related questionnaires.

Interested in participating?

To learn more about the study, please visit the following links: www.mycladstudy.com and NCT06463587 | ClinicalTrials.gov.

If you have questions or inquiries about participation, contact the US Medical Information at EMD Serono – phone number: 888-275-7376 and email: eMediUSA@emdserono.com