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Clinical Trial: A phase 1 safety study of ANK-700 in people with relapsing-remitting MS

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Details
Type of MS: RRMS
Treatment mode of action: immune tolerance
Number of Subjects: 33
Medication: ANK-700
Location: Alabama|Colorado|Florida|Kansas|Louisiana|Ohio|Pennsylvania|Tennessee|Texas|Virginia|Washington
Institutions: Multicenter, nationwide Contact Information
Please see below

Funding:

Anokion SA

Description

Study Rationale: Multiple sclerosis (MS) is a neurological disease that causes damage to the brain and spinal cord, and steadily worsens over time. As the central nervous system (CNS) controls most body functions, people living with MS can experience a wide range of symptoms. Typically, MS symptoms include weakness, lack of coordination, numbness, problems with speech, and blurred vision. ANK-700 specifically targets the immune cells that drive MS and leaves the otherwise healthy components of the immune system intact. ANK-700 may help people with MS, without interfering with the natural, protective functions of the immune system. Investigators at 7 to 15 sites in the United States are recruiting approximately 33 people with relapsing-remitting MS to assess the safety of ANK-700. The study is divided into 2 parts, Part A and Part B. 

Part A: Part A will enroll approximately 9 people. Enrollment for Part A is expected to be filled by April 2022. The study will last for 6 months and consist of 7 visits to the study site. All participants will receive a single dose of ANK-700. The following assessments will also be conducted during the study: 
•    Expanded Disability Status Scale (EDSS) is conducted to see how MS affects people’s ability to move 
•    MRI of the brain will be performed
•    Blood samples will be drawn at each study visit

Part B: Part B will enroll approximately 24 people. The study will last for 1 year and consist of 9 visits to the study site. Participants will receive 3 doses of either ANK-700 or placebo. The following assessments will also be conducted during the study: 
•    Expanded Disability Status Scale (EDSS) is conducted to see how MS affects people’s ability to move
•    MRI of the brain will be performed
•    Blood samples will be drawn at each study visit

Eligibility:
•    Adult participants 18-60 years of age
•    Diagnosed with relapsing-remitting MS (RRMS)
•    Participants not currently taking disease modifying medications for treatment of MS; OR participants who currently take a stable dose of fumarate medications for treatment of MS.
Note: Part B participants will be able to add additional MS medications as needed following their day 90 visit.

Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact the site nearest you listed on clinicaltrials.gov, https://clinicaltrials.gov/ct2/show/NCT04602390. If there is no study site near you, please check back as additional study sites are being added. 
 
Sites are enrolling in the following cities: 
Aurora, Colorado
Cleveland, Ohio
Cullman, Alabama
Franklin, Tennessee
Dallas, Texas
Houston, Texas
Tacoma, Washington
Philadelphia, Pennsylvania
Kansas City, Kansas
Vienna, Virginia
New Orleans, Louisiana
Naples, Florida

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© 2022 The National Multiple Sclerosis Society is a tax exempt 501(c)3 nonprofit organization. Its Identification Number (EIN) is 13-5661935.