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

Primary Purpose

Multiple Sclerosis (MS), Relapsing Remitting Multiple Sclerosis

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ANK-700
Placebo
Sponsored by
Anokion SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis (MS) focused on measuring Autoimmune, Multiple Sclerosis (MS), Relapsing Remitting MS

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North Central Neurology
  • Barrow Neurological Institute
  • UC Health Neurosciences Center
  • Aqualane Clinical Research
  • University of South Florida - Neurology
  • University of Kansas Lander Center on Aging/ Neurology
  • Ochsner Clinic Foundation
  • Cleveland Clinic
  • Jefferson University Hospitals
  • Midlands Neurology & Pain Associates PA
  • Advanced Neurosciences Institute
  • University of Texas Southwestern
  • University of Texas Health Science Center
  • MS Center of Greater Washington
  • MultiCare Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

ANK-700 SAD Cohort 1, Dose A

ANK-700 SAD Cohort 2, Dose B

ANK-700 SAD Cohort 3 Dose C

MAD Cohort 4 ANK-700 Dose A or Placebo

MAD Cohort 5 ANK-700 Dose B or placebo

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Geometric mean of maximum plasma concentration (Cmax)
Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last)

Full Information

First Posted
October 5, 2020
Last Updated
July 26, 2023
Sponsor
Anokion SA
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1. Study Identification

Unique Protocol Identification Number
NCT04602390
Brief Title
Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis
Acronym
MoveS-it
Official Title
A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 6, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anokion SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis (MS), Relapsing Remitting Multiple Sclerosis
Keywords
Autoimmune, Multiple Sclerosis (MS), Relapsing Remitting MS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ANK-700 SAD Cohort 1, Dose A
Arm Type
Experimental
Arm Description
All enrolled patients will receive one dose of ANK-700 Dose A
Arm Title
ANK-700 SAD Cohort 2, Dose B
Arm Type
Experimental
Arm Description
All enrolled patients will receive one dose of ANK-700 Dose B
Arm Title
ANK-700 SAD Cohort 3 Dose C
Arm Type
Experimental
Arm Description
All enrolled patients will receive one dose of ANK-700 Dose C
Arm Title
MAD Cohort 4 ANK-700 Dose A or Placebo
Arm Type
Experimental
Arm Description
All enrolled patients will receive three doses of ANK-700 Dose A or placebo
Arm Title
MAD Cohort 5 ANK-700 Dose B or placebo
Arm Type
Experimental
Arm Description
All enrolled patients will receive three doses of ANK-700 Dose B or placebo
Intervention Type
Drug
Intervention Name(s)
ANK-700
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous (IV) infusion
Primary Outcome Measure Information:
Title
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
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Geometric mean of maximum plasma concentration (Cmax)
Time Frame
Up to 21 days
Title
Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last)
Time Frame
Up to 21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
North Central Neurology
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
UC Health Neurosciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Aqualane Clinical Research
City
Naples
State/Province
Florida
ZIP/Postal Code
34105
Country
United States
Facility Name
University of South Florida - Neurology
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Kansas Lander Center on Aging/ Neurology
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66103
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Jefferson University Hospitals
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Midlands Neurology & Pain Associates PA
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29205
Country
United States
Facility Name
Advanced Neurosciences Institute
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MS Center of Greater Washington
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22180
Country
United States
Facility Name
MultiCare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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