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

Relapsing Remitting Multiple Sclerosis Clinical Trial

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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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04602390
• Other study ID #: ANK-700-01
• Status: Active, not recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis (MS)
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

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