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

A

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

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

Trial contacts and locations

15

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Central trial contact

Anokion SA

Data sourced from clinicaltrials.gov

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