Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis (MoveS-it)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Relapsing Remitting Multiple Sclerosis; Multiple Sclerosis (MS)
• Intervention / Treatment: Drug: Placebo; Drug: ANK-700

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.

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Anokion SA; Phone Number: +1 857-320-6607; Email: clinicaltrials@anokion.com

Study Locations

• United States
  • Alabama
    • Cullman, Alabama, United States, 35058
      • North Central Neurology
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute
  • Colorado
    • Aurora, Colorado, United States, 80045
      • UC Health Neurosciences Center
  • Florida
    • Naples, Florida, United States, 34105
      • Aqualane Clinical Research
    • Tampa, Florida, United States, 33612
      • University of South Florida - Neurology
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • University of Kansas Lander Center on Aging/ Neurology
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson University Hospitals
  • South Carolina
    • Columbia, South Carolina, United States, 29205
      • Midlands Neurology & Pain Associates PA
  • Tennessee
    • Franklin, Tennessee, United States, 37064
      • Advanced Neurosciences Institute
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center
  • Virginia
    • Vienna, Virginia, United States, 22180
      • MS Center of Greater Washington
  • Washington
    • Tacoma, Washington, United States, 98405
      • Multicare Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Placebo; Intravenous (IV) infusion; Drug: ANK-700; 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: Placebo; Intravenous (IV) infusion; Drug: ANK-700; Intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 or higher	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Geometric mean of maximum plasma concentration (Cmax)	Up to 21 days
Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last)	Up to 21 days

Collaborators and Investigators

• Sponsor: Anokion SA

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Relapsing Remitting MS; Autoimmune; Multiple Sclerosis (MS)
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: ANK-700-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No