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

• ClinicalTrials.gov Identifier: NCT04602390
• Recruitment Status: Active, not recruiting
• First Posted: October 26, 2020
• Last Update Posted: July 27, 2023
• Sponsor: Anokion SA
• Information provided by (Responsible Party): Anokion SA

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

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis (MS); Relapsing Remitting Multiple Sclerosis	Drug: ANK-700; Drug: Placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: November 6, 2020
• Estimated Primary Completion Date: June 2024
• Estimated Study Completion Date: June 2024

Arms and Interventions

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: 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

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. Geometric mean of maximum plasma concentration (Cmax) [ Time Frame: Up to 21 days ]
2. Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last) [ Time Frame: Up to 21 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

North Central Neurology

Cullman, Alabama, United States, 35058

United States, Arizona

Barrow Neurological Institute

Phoenix, Arizona, United States, 85013

United States, Colorado

UC Health Neurosciences Center

Aurora, Colorado, United States, 80045

United States, Florida

Aqualane Clinical Research

Naples, Florida, United States, 34105

University of South Florida - Neurology

Tampa, Florida, United States, 33612

United States, Kansas

University of Kansas Lander Center on Aging/ Neurology

Kansas City, Kansas, United States, 66103

United States, Louisiana

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

United States, Pennsylvania

Jefferson University Hospitals

Philadelphia, Pennsylvania, United States, 19107

United States, South Carolina

Midlands Neurology & Pain Associates PA

Columbia, South Carolina, United States, 29205

United States, Tennessee

Advanced Neurosciences Institute

Franklin, Tennessee, United States, 37064

United States, Texas

University of Texas Southwestern

Dallas, Texas, United States, 75390

University of Texas Health Science Center

Houston, Texas, United States, 77030

United States, Virginia

MS Center of Greater Washington

Vienna, Virginia, United States, 22180

United States, Washington

MultiCare Health System

Tacoma, Washington, United States, 98405

Sponsors and Collaborators

Anokion SA

More Information

• Responsible Party: Anokion SA
• ClinicalTrials.gov Identifier: NCT04602390
• Other Study ID Numbers: ANK-700-01
• First Posted: October 26, 2020
• Last Update Posted: July 27, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anokion SA:

Autoimmune; Multiple Sclerosis (MS); Relapsing Remitting MS

Additional relevant MeSH terms:

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases