Below we have provided an update from Biogen regarding the status of its DEVOTE clinical trial. For more information about SPINRAZA (nusinersen), visit https://www.curesma.org/spinraza/.
Biogen’s DEVOTE study is designed to evaluate the safety, tolerability, and potential for even greater efficacy of SPINRAZA when administered at a higher dose than currently approved for the treatment of spinal muscular atrophy (SMA). The Phase 2/3 randomized, controlled, dose-escalating study will be conducted at approximately 60 sites in 26 countries around the world, and aims to enroll 152 individuals of all ages with SMA.
The three-part study will include an open-label safety evaluation cohort (called Part A) and a pivotal, double-blind, active control randomized treatment cohort (called Part B), followed by an open-label, transitional, treatment cohort (called Part C). Check out this brochure with more information about the DEVOTE study. There is also a website with more information, www.devotesmastudy.com, and of course, there is further information on www.clinicaltrials.gov (NCT04089566).
In addition, Biogen held a community discussion on DEVOTE in February 2020, with a recording available here on Cure SMA’s YouTube channel. In April, Biogen announced that the first person enrolled in Part A of the study was treated with a higher dose of SPINRAZA. Recently, the safety evaluation cohort (Part A) completed enrollment and reached a previously specified time point with no safety concerns. Therefore, study investigators are now beginning to screen participants for the pivotal cohort, Part B. The first subject dosed in Part B occurred on November 12. This part of the clinical trial is pivotal and crucial, and Biogen is working closely with study investigators at current sites to identify and enroll participants as quickly as possible, including at the following two enrollment sites in the U.S. that are currently recruiting:
- Stanford Hospital and Clinics
- Ann and Robert H. Lurie Children’s Hospital of Chicago
Biogen anticipates the following enrollment sites in the U.S. to be recruiting by the end of March 2021:
- Children’s Hospital Colorado
- Boston Children’s Hospital
- St. Jude’s Children’s Research Hospital
- University of Texas Southwestern Medical Center
As noted on clinicaltrials.gov, Biogen is also enrolling individuals with SMA from around the world through a network of enrollment sites in Columbia, Estonia, Hungary, Ireland, Latvia, Spain, and Taiwan. As new countries and sites are open to enroll subjects, they will be listed on clinicaltrials.gov. As previously mentioned, Biogen has approximately 60 sites in 26 countries expected to participate in this clinical study.
Lastly, two final updates about DEVOTE: First, travel support for clinical trial participants may be available in the form of coordination and coverage of expenses. Depending on a participant’s distance to the study location, this may include ground transportation, flight, and hotel. Secondly, as mentioned on the webinar last winter, following completion of the DEVOTE study, participants may have the option to enroll in a long-term, open-label, extension study and receive a higher dose of SPINRAZA.
In addition to the resources mentioned, individuals interested in participating in this study can email Biogen at [email protected]. Individuals located in the U.S. can also call the Biogen Clinical Trials Center at 866-633-4636.