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

NCT04602390 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: ANK-700-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 15

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

Conditions

Multiple Sclerosis (MS); Relapsing Remitting Multiple Sclerosis

Keywords

Autoimmune; Multiple Sclerosis (MS); Relapsing Remitting MS

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher

  Up to 1 year

Secondary Outcomes (2)

• CMAX

  Days 1 and 7: One PK sample was taken pre-dose (≥at least 5 min prior to infusion), with all subsequent PK samples taken after end of infusion at the following time points: 0 min, 7min, 15min, 30min, 1h, 2h, 3h, 4h, 6h, 8h

• AUC Last

  Days 1 and 7: One PK sample was taken pre-dose (≥at least 5 min prior to infusion), with all subsequent PK samples taken after the end-of-infusion at the following time points: 0 min, 7 min, 15min, 30 min, 1h, 2h, 3h, 4h, 6h, 8h

Study Arms (5)

ANK-700 SAD Cohort 1, 0.3 mg/kg ANK-700

EXPERIMENTAL

All enrolled patients will receive one dose of 0.3 mg/kg ANK-700

Drug: ANK-700

ANK-700 SAD Cohort 2, 1.0 mg/kg ANK-700

EXPERIMENTAL

All enrolled patients will receive one dose of 1.0 mg/kg ANK-700

Drug: ANK-700

ANK-700 SAD Cohort 3, 3.0 mg/kg ANK-700

EXPERIMENTAL

All enrolled patients will receive one dose of 3.0 mg/kg ANK-700

Drug: ANK-700

MAD Cohort 4 0.3 mg/kg ANK-700 or Placebo

EXPERIMENTAL

All enrolled patients will receive three doses of 0.3 mg/kg ANK-700 or placebo

Drug: ANK-700; Drug: Placebo

MAD Cohort 5 1.0 mg/kg ANK-700 or placebo

EXPERIMENTAL

All enrolled patients will receive three doses of 1.0 mg/kg ANK-700 or placebo

Drug: ANK-700; Drug: Placebo

Interventions

ANK-700 DRUG

Intravenous (IV) infusion

ANK-700 SAD Cohort 1, 0.3 mg/kg ANK-700; ANK-700 SAD Cohort 2, 1.0 mg/kg ANK-700; ANK-700 SAD Cohort 3, 3.0 mg/kg ANK-700; MAD Cohort 4 0.3 mg/kg ANK-700 or Placebo; MAD Cohort 5 1.0 mg/kg ANK-700 or placebo

Placebo DRUG

Intravenous (IV) infusion

MAD Cohort 4 0.3 mg/kg ANK-700 or Placebo; MAD Cohort 5 1.0 mg/kg ANK-700 or placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anokion SA: lead

Study Sites (15)

North Central Neurology

Cullman, Alabama, 35058, United States

Location

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

UC Health Neurosciences Center

Aurora, Colorado, 80045, United States

Location

Aqualane Clinical Research

Naples, Florida, 34105, United States

Location

University of South Florida - Neurology

Tampa, Florida, 33612, United States

Location

University of Kansas Lander Center on Aging/ Neurology

Kansas City, Kansas, 66103, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Jefferson University Hospitals

Philadelphia, Pennsylvania, 19107, United States

Location

Midlands Neurology & Pain Associates PA

Columbia, South Carolina, 29205, United States

Location

Advanced Neurosciences Institute

Franklin, Tennessee, 37064, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

MS Center of Greater Washington

Vienna, Virginia, 22180, United States

Location

MultiCare Health System

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Anokion US

clinicaltrials@anokion.com

+1 857.320.6607

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 26, 2020
• Study Start: November 6, 2020
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: May 31, 2025
• Results First Posted: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)