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

Purpose

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

Conditions

  • Multiple Sclerosis (MS)
  • Relapsing Remitting Multiple Sclerosis

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ANK-700 SAD Cohort 1, Dose A 		All enrolled patients will receive one dose of ANK-700 Dose A
  • Drug: ANK-700
    Intravenous (IV) infusion
Experimental
ANK-700 SAD Cohort 2, Dose B 		All enrolled patients will receive one dose of ANK-700 Dose B
  • Drug: ANK-700
    Intravenous (IV) infusion
Experimental
ANK-700 SAD Cohort 3 Dose C 		All enrolled patients will receive one dose of ANK-700 Dose C
  • Drug: ANK-700
    Intravenous (IV) infusion
Experimental
MAD Cohort 4 ANK-700 Dose A or Placebo 		All enrolled patients will receive three doses of ANK-700 Dose A or placebo
  • Drug: ANK-700
    Intravenous (IV) infusion
  • Drug: Placebo
    Intravenous (IV) infusion
Experimental
MAD Cohort 5 ANK-700 Dose B or placebo 		All enrolled patients will receive three doses of ANK-700 Dose B or placebo
  • Drug: ANK-700
    Intravenous (IV) infusion
  • Drug: Placebo
    Intravenous (IV) infusion

More Details

Status
Active, not recruiting
Sponsor
Anokion SA

Study Contact

Detailed 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.