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Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT04602390•Anokion SA

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

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
+2 more criteria

Locations (15)

North Central Neurology

Cullman, Alabama, United States

Barrow Neurological Institute

Phoenix, Arizona, United States

UC Health Neurosciences Center

Aurora, Colorado, United States

Aqualane Clinical Research

Naples, Florida, United States

University of South Florida - Neurology

Tampa, Florida, United States

University of Kansas Lander Center on Aging/ Neurology

Kansas City, Kansas, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Cleveland Clinic

Cleveland, Ohio, United States

Jefferson University Hospitals

Philadelphia, Pennsylvania, United States

Midlands Neurology & Pain Associates PA

Columbia, South Carolina, United States

Key Dates

Start Date

November 6, 2020

Primary Completion Date

April 23, 2024

Completion Date

April 23, 2024

Last Updated

May 31, 2025

Enrollment

ACTUAL participants

Conditions

Multiple Sclerosis (MS)Relapsing Remitting Multiple Sclerosis

Interventions

ANK-700

DRUG

Placebo

DRUG

Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy

NCT05359653

Multiple Sclerosis (MS)Multiple Sclerosis, Relapsing-Remitting+5 more

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RECRUITINGNA

Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study

NCT07376772

Multiple Sclerosis (MS) - Relapsing-remittingUpper Extremity Dysfunction

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy

Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study

Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)

Pregnancy Cohort in Multiple Sclerosis (MS)

An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and Sweden

Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: The ADVICE Protocol Study (Phase 1)