Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis
NCT ID: NCT04602390
Last Updated: 2025-05-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
34 participants
INTERVENTIONAL
2020-11-06
2024-04-23
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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ANK-700 SAD Cohort 1, 0.3 mg/kg ANK-700
All enrolled patients will receive one dose of 0.3 mg/kg ANK-700
ANK-700
Intravenous (IV) infusion
ANK-700 SAD Cohort 2, 1.0 mg/kg ANK-700
All enrolled patients will receive one dose of 1.0 mg/kg ANK-700
ANK-700
Intravenous (IV) infusion
ANK-700 SAD Cohort 3, 3.0 mg/kg ANK-700
All enrolled patients will receive one dose of 3.0 mg/kg ANK-700
ANK-700
Intravenous (IV) infusion
MAD Cohort 4 0.3 mg/kg ANK-700 or Placebo
All enrolled patients will receive three doses of 0.3 mg/kg ANK-700 or placebo
ANK-700
Intravenous (IV) infusion
Placebo
Intravenous (IV) infusion
MAD Cohort 5 1.0 mg/kg ANK-700 or placebo
All enrolled patients will receive three doses of 1.0 mg/kg ANK-700 or placebo
ANK-700
Intravenous (IV) infusion
Placebo
Intravenous (IV) infusion
Interventions
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ANK-700
Intravenous (IV) infusion
Placebo
Intravenous (IV) infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Anokion SA
INDUSTRY
Responsible Party
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Locations
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North Central Neurology
Cullman, Alabama, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
UC Health Neurosciences Center
Aurora, Colorado, United States
Aqualane Clinical Research
Naples, Florida, United States
University of South Florida - Neurology
Tampa, Florida, United States
University of Kansas Lander Center on Aging/ Neurology
Kansas City, Kansas, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Cleveland Clinic
Cleveland, Ohio, United States
Jefferson University Hospitals
Philadelphia, Pennsylvania, United States
Midlands Neurology & Pain Associates PA
Columbia, South Carolina, United States
Advanced Neurosciences Institute
Franklin, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Texas Health Science Center
Houston, Texas, United States
MS Center of Greater Washington
Vienna, Virginia, United States
MultiCare Health System
Tacoma, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ANK-700-01
Identifier Type: -
Identifier Source: org_study_id
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