Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis

Completed · Phase 1 · Has a placebo group

Conditions studied: Multiple Sclerosis (MS), Relapsing Remitting Multiple Sclerosis

In brief

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

Key facts

Study ID: NCT04602390
Run by: Anokion SA
People needed: 34
Starts: 2020-11-06
Expected to finish: 2024-04-23
Last updated by the study team: 2025-05-31

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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