Multiple Sclerosis Clinical Trial
Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis
Summary
A safety study of ANK-700 in patients with relapsing remitting multiple sclerosis. The study has two parts:
Part A - first in human study in which patients receive a single dose of ANK-700 Part B - patients will receive three doses of either ANK-700 or placebo
Full Description
Study ANK-700-01 is a Phase 1, FIH study designed to evaluate the safety and tolerability of ANK-700 in patients with relapsing remitting multiple sclerosis (rrms).
An overview of the two parts and proposed dose groups is given below:
Part A (SAD): Patients will receive a single dose of ANK-700. Part B (MAD): Patients will receive three doses of either ANK-700 or placebo.
Eligibility Criteria
Inclusion Criteria:
Diagnosed with RRMS per revised McDonald criteria (2017) with an EDSS score ≤ 6.5 at screening
Neurologically stable with no evidence of relapse within the 28 days before signing the informed consent form (ICF)
Either not currently receiving disease modifying MS therapy, or currently using fumarate drugs (dimethyl fumarate or diroximel fumarate)
Patients must use a highly effective method of birth control or are sterile or postmenopausal as confirmed by study Investigator
Patient has signed and understands the ICF
Exclusion Criteria:
Diagnosis of primary progressive MS or secondary progressive MS
Uncontrolled or significant medical conditions (including active infection or chronic hepatitis) which, in the opinion of the Investigator, preclude participation
Patients treated with glatiramer acetate, parenteral steroids or adrenocorticotropic hormone, β-interferon, plasma exchange within the 3 months prior to first dose
Patients treated with sphingosine-1-phospate receptor modulators such as fingolimod, ozanimod, or siponimod within 6 months prior to first dose
Patients treated with cytotoxic agents (including, but not limited to, cladribine, mitoxantrone, cyclophosphamide, azathioprine, and methotrexate), laquinimod, teriflunomide, or IV gamma globulin within 12 months prior to first dose
Patients treated with monoclonal antibody therapy (including natalizumab, daclizumab, rituximab, ofatumumab, and ocrelizumab) within 24 months prior to first dose
Patients previously treated with alemtuzumab, total lymphoid irradiation, mesenchymal stem cell or hematopoietic stem cell transplantation, or tolerance-inducing therapies for MS
Contraindication to or inability to undergo gadolinium-enhanced magnetic resonance imaging (MRI) scan
Use of any investigational drug or experimental procedure within previous 6 months that would interfere with the assessment of ANK-700
Patients who are pregnant or breastfeeding
Patients receiving any vaccination within 28 days prior to first dose
Patient does not agree to limit alcohol intake to 2 drink equivalents or less per day during the study
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There are 15 Locations for this study
Cullman Alabama, 35058, United States
Phoenix Arizona, 85013, United States
Aurora Colorado, 80045, United States
Naples Florida, 34105, United States
Tampa Florida, 33612, United States
Kansas City Kansas, 66103, United States
New Orleans Louisiana, 70121, United States
Cleveland Ohio, 44195, United States
Philadelphia Pennsylvania, 19107, United States
Columbia South Carolina, 29205, United States
Franklin Tennessee, 37064, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Vienna Virginia, 22180, United States
Tacoma Washington, 98405, United States
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