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

Anokion

Status and phase: Active, not recruiting; Phase 1

Conditions: Multiple Sclerosis (MS); Relapsing Remitting Multiple Sclerosis

Treatments: Drug: Placebo; Drug: ANK-700

Study type: Interventional

Funder types: Industry

Identifiers

NCT04602390

ANK-700-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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33 participants in 5 patient groups

ANK-700 SAD Cohort 1, Dose A

Experimental group

Description:

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

Treatment:

Drug: ANK-700

ANK-700 SAD Cohort 2, Dose B

Experimental group

Description:

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

Treatment:

Drug: ANK-700

ANK-700 SAD Cohort 3 Dose C

Experimental group

Description:

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

Treatment:

Drug: ANK-700

MAD Cohort 4 ANK-700 Dose A or Placebo

Experimental group

Description:

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

Treatment:

Drug: ANK-700

Drug: Placebo

MAD Cohort 5 ANK-700 Dose B or placebo

Experimental group

Description:

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

Treatment:

Drug: ANK-700

Drug: Placebo