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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04602390
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
Anokion SA

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 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.

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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 : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 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, fingolimod, ozanimod, or siponimod within the 3 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602390


Contacts
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Contact: Anokion US, Inc +1 857-320-6607 clinicaltrials@anokion.com

Locations
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United States, Colorado
UC Health Neurosciences Center Recruiting
Aurora, Colorado, United States, 80045
Contact: José Parra Gonzalez       jose.parragonzalez@cuanschutz.edu   
Principal Investigator: Timothy Vollmer, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Leah Tardivo       tardivl@ccf.org   
Principal Investigator: Jeffrey Cohen, MD         
United States, Pennsylvania
Jefferson University Hospitals Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Angira Mathur       angira.mathur@jefferson.edu   
Principal Investigator: Thomas P Leist, MD         
United States, Tennessee
Advanced Neurosciences Institute Recruiting
Franklin, Tennessee, United States, 37064
Contact: Samuel Hunter, MD    615-791-5470    FrontOffice@neurosci.us   
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Monae Carpenter       Monae.Carpenter@UTSouthwestern.edu   
Principal Investigator: Benjamin Greenberg, MD         
University of Texas Health Science Center Recruiting
Houston, Texas, United States, 77030
Contact: Jim Jemelka       James.R.Jemelka@uth.tmc.edu   
Principal Investigator: John W Lindsey, MD         
United States, Washington
MultiCare Health System Recruiting
Tacoma, Washington, United States, 98405
Contact: Tonya Stigger       tstigger@multicare.org   
Principal Investigator: Stacy Donlon, MD         
Sponsors and Collaborators
Anokion SA
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Responsible Party: Anokion SA
ClinicalTrials.gov Identifier: NCT04602390    
Other Study ID Numbers: ANK-700-01
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
relapsing remitting ms
Additional relevant MeSH terms:
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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