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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04602390
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Anokion SA
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis (MS), Relapsing Remitting Multiple Sclerosis
Additional Details

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.

Arms & Interventions

Arms

Experimental: ANK-700 SAD Cohort 1, Dose A

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

Experimental: ANK-700 SAD Cohort 2, Dose B

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

Experimental: ANK-700 SAD Cohort 3 Dose C

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

Experimental: MAD Cohort 4 ANK-700 Dose A or Placebo

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

Experimental: MAD Cohort 5 ANK-700 Dose B or placebo

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

Interventions

Drug: - ANK-700

Intravenous (IV) infusion

Drug: - Placebo

Intravenous (IV) infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

North Central Neurology, Cullman, Alabama

Status

Recruiting

Address

North Central Neurology

Cullman, Alabama, 35058

Site Contact

Marla Morris

[email protected]

256-739-1210

Barrow Neurological Institute, Phoenix, Arizona

Status

Recruiting

Address

Barrow Neurological Institute

Phoenix, Arizona, 85013

Site Contact

Mary Thornton

[email protected]

602-406-6287

UC Health Neurosciences Center, Aurora, Colorado

Status

Recruiting

Address

UC Health Neurosciences Center

Aurora, Colorado, 80045

Site Contact

Sama Kareem

[email protected]

720-472-2254

Aqualane Clinical Research, Naples, Florida

Status

Recruiting

Address

Aqualane Clinical Research

Naples, Florida, 34105

Site Contact

Daniela Gonzalez

[email protected]

239-434-0332

University of South Florida - Neurology, Tampa, Florida

Status

Recruiting

Address

University of South Florida - Neurology

Tampa, Florida, 33612

Site Contact

Amber McPherson

[email protected]

813-974-2423

Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Lander Center on Aging/ Neurology

Kansas City, Kansas, 66103

Site Contact

Lisa Schmidt

[email protected]

913-588-1227

Ochsner Clinic Foundation, New Orleans, Louisiana

Status

Recruiting

Address

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121

Site Contact

Maya Friedman

[email protected]

504-843-4819

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

Leah Tardivo

[email protected]

216-445-5788

Jefferson University Hospitals, Philadelphia, Pennsylvania

Status

Recruiting

Address

Jefferson University Hospitals

Philadelphia, Pennsylvania, 19107

Site Contact

Angira Mathur

[email protected]

215-955-5765

First Care Research Center, Columbia, South Carolina

Status

Recruiting

Address

First Care Research Center

Columbia, South Carolina, 29205

Site Contact

Sandra Arinze

[email protected]

774-271-4194

Advanced Neurosciences Institute, Franklin, Tennessee

Status

Recruiting

Address

Advanced Neurosciences Institute

Franklin, Tennessee, 37064

Site Contact

Samuel Hunter, MD

[email protected]

615-791-5470

University of Texas Southwestern, Dallas, Texas

Status

Recruiting

Address

University of Texas Southwestern

Dallas, Texas, 75390

Site Contact

Taylor Quance

[email protected]

214-645-3230

Houston, Texas

Status

Recruiting

Address

University of Texas Health Science Center

Houston, Texas, 77030

Site Contact

Jim Jemelka

[email protected]

713-704-4137

MS Center of Greater Washington, Vienna, Virginia

Status

Recruiting

Address

MS Center of Greater Washington

Vienna, Virginia, 22180

Site Contact

Rebeca Marin

[email protected]

703-226-4030

MultiCare Health System, Tacoma, Washington

Status

Recruiting

Address

MultiCare Health System

Tacoma, Washington, 98405

Site Contact

Tonya Stigger

[email protected]

253-403-1208

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

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Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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