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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anokion SA

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, fingolimod, ozanimod, or siponimod within the 3 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