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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04602390
Other study ID # ANK-700-01
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date November 6, 2020
Est. completion date June 2024

Study information

Verified date July 2023
Source Anokion SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 33
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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, ß-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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ANK-700
Intravenous (IV) infusion
Placebo
Intravenous (IV) infusion

Locations

Country Name City State
United States UC Health Neurosciences Center Aurora Colorado
United States Cleveland Clinic Cleveland Ohio
United States Midlands Neurology & Pain Associates PA Columbia South Carolina
United States North Central Neurology Cullman Alabama
United States University of Texas Southwestern Dallas Texas
United States Advanced Neurosciences Institute Franklin Tennessee
United States University of Texas Health Science Center Houston Texas
United States University of Kansas Lander Center on Aging/ Neurology Kansas City Kansas
United States Aqualane Clinical Research Naples Florida
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Jefferson University Hospitals Philadelphia Pennsylvania
United States Barrow Neurological Institute Phoenix Arizona
United States MultiCare Health System Tacoma Washington
United States University of South Florida - Neurology Tampa Florida
United States MS Center of Greater Washington Vienna Virginia

Sponsors (1)

Lead Sponsor Collaborator
Anokion SA

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Up to 1 year
Secondary Geometric mean of maximum plasma concentration (Cmax) Up to 21 days
Secondary Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last) Up to 21 days
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