Trial | NCT04602390  Report issue

Title

Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis
A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Intervention/Treatment

    ANK-700 ...

  • Study Participants

    33
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
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.
Study Started
Nov 06
2020
Primary Completion
Jun 30
2024
Anticipated
Study Completion
Jun 30
2024
Anticipated
Last Update
Jul 27
2023

Drug ANK-700

Intravenous (IV) infusion

Drug Placebo

Intravenous (IV) infusion

ANK-700 SAD Cohort 1, Dose A Experimental

All enrolled patients will receive one dose of ANK-700 Dose A

ANK-700 SAD Cohort 2, Dose B Experimental

All enrolled patients will receive one dose of ANK-700 Dose B

ANK-700 SAD Cohort 3 Dose C Experimental

All enrolled patients will receive one dose of ANK-700 Dose C

MAD Cohort 4 ANK-700 Dose A or Placebo Experimental

All enrolled patients will receive three doses of ANK-700 Dose A or placebo

MAD Cohort 5 ANK-700 Dose B or placebo Experimental

All enrolled patients will receive three doses of ANK-700 Dose B or placebo

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
No Results Posted