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

CompletedPhase 1

Sponsor: Anokion SA

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

Interventions: ANK-700, Placebo

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (15)

Cullman, Alabama, United States
Phoenix, Arizona, United States
Aurora, Colorado, United States
Naples, Florida, United States
Tampa, Florida, United States
Kansas City, Kansas, United States
New Orleans, Louisiana, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Columbia, South Carolina, United States
Franklin, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Vienna, Virginia, United States
Tacoma, Washington, United States