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

Sponsor

Anokion SA (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04602390

Collaborator

(none)

Enrollment

Locations

Arms

36.8

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis Relapsing Remitting Multiple Sclerosis	Drug: ANK-700 Drug: Placebo	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 6, 2020

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ANK-700 SAD Cohort 1, Dose A All enrolled patients will receive one dose of ANK-700 Dose A	Drug: ANK-700 Intravenous (IV) infusion
Experimental: ANK-700 SAD Cohort 2, Dose B All enrolled patients will receive one dose of ANK-700 Dose B	Drug: ANK-700 Intravenous (IV) infusion
Experimental: ANK-700 SAD Cohort 3 Dose C All enrolled patients will receive one dose of ANK-700 Dose C	Drug: ANK-700 Intravenous (IV) infusion
Experimental: MAD Cohort 4 ANK-700 Dose A or Placebo All enrolled patients will receive three doses of ANK-700 Dose A or placebo	Drug: ANK-700 Intravenous (IV) infusion Drug: Placebo Intravenous (IV) infusion
Experimental: MAD Cohort 5 ANK-700 Dose B or placebo All enrolled patients will receive three doses of ANK-700 Dose B or placebo	Drug: ANK-700 Intravenous (IV) infusion Drug: Placebo Intravenous (IV) infusion

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Geometric mean of maximum plasma concentration (Cmax) [Up to 21 days]
Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last) [Up to 21 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Health Neurosciences Center	Aurora	Colorado	United States	80045
2	Collier Neurologic	Naples	Florida	United States	34105
3	University of Kansas Lander Center on Aging/ Neurology	Kansas City	Kansas	United States	66103
4	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
5	Cleveland Clinic	Cleveland	Ohio	United States	44195
6	Jefferson University Hospitals	Philadelphia	Pennsylvania	United States	19107
7	Advanced Neurosciences Institute	Franklin	Tennessee	United States	37064
8	University of Texas Southwestern	Dallas	Texas	United States	75390
9	University of Texas Health Science Center	Houston	Texas	United States	77030
10	MS Center of Greater Washington	Vienna	Virginia	United States	22180
11	MultiCare Health System	Tacoma	Washington	United States	98405