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

• ClinicalTrials.gov Identifier: NCT04602390
• Recruitment Status: Active, not recruiting
• First Posted: October 26, 2020
• Last Update Posted: July 27, 2023
• Sponsor: Anokion SA
• Information provided by (Responsible Party): Anokion SA

Tracking Information

• First Submitted Date: October 5, 2020
• First Posted Date: October 26, 2020
• Last Update Posted Date: July 27, 2023
• Actual Study Start Date: November 6, 2020
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 20, 2020): 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 [ Time Frame: Up to 1 year ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 20, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis
• 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

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

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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Multiple Sclerosis (MS)
• Relapsing Remitting Multiple Sclerosis

Intervention

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

Study Arms

• Experimental: ANK-700 SAD Cohort 1, Dose A
  All enrolled patients will receive one dose of ANK-700 Dose A
  Intervention: Drug: ANK-700
• Experimental: ANK-700 SAD Cohort 2, Dose B
  All enrolled patients will receive one dose of ANK-700 Dose B
  Intervention: Drug: ANK-700
• Experimental: ANK-700 SAD Cohort 3 Dose C
  All enrolled patients will receive one dose of ANK-700 Dose C
  Intervention: Drug: ANK-700
• Experimental: MAD Cohort 4 ANK-700 Dose A or Placebo
  All enrolled patients will receive three doses of ANK-700 Dose A or placebo
  Interventions:

  • Drug: ANK-700
  • Drug: Placebo
• Experimental: MAD Cohort 5 ANK-700 Dose B or placebo
  All enrolled patients will receive three doses of ANK-700 Dose B or placebo
  Interventions:

  • Drug: ANK-700
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: October 20, 2020): 33
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2024
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04602390
• Other Study ID Numbers: ANK-700-01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Anokion SA
• Original Responsible Party: Same as current
• Current Study Sponsor: Anokion SA
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Anokion SA
• Verification Date: July 2023