Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis (MoveS-it)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04602390 |
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Recruitment Status :
Recruiting
First Posted : October 26, 2020
Last Update Posted : December 15, 2022
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Sponsor:
Anokion SA
Information provided by (Responsible Party):
Anokion SA
- Study Details
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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 (MS) Relapsing Remitting Multiple Sclerosis | Drug: ANK-700 Drug: Placebo | Phase 1 |
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 (Clinical Trial) |
| Estimated 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 : | November 6, 2020 |
| Estimated Primary Completion Date : | June 2024 |
| Estimated Study Completion Date : | June 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
| Arm | Intervention/treatment |
|---|---|
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Experimental: ANK-700 SAD Cohort 1, Dose A
All enrolled patients will receive one dose of ANK-700 Dose A
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Drug: ANK-700
Intravenous (IV) infusion |
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Experimental: ANK-700 SAD Cohort 2, Dose B
All enrolled patients will receive one dose of ANK-700 Dose B
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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
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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 |
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 [ Time Frame: Up to 1 year ]
Secondary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602390
Contacts
| Contact: Anokion SA | +1 857-320-6607 | clinicaltrials@anokion.com |
Locations
| United States, Alabama | |
| North Central Neurology | Recruiting |
| Cullman, Alabama, United States, 35058 | |
| Contact: Marla Morris 256-739-1210 MMorris@prn-inc.net | |
| Principal Investigator: Christopher Laganke, MD | |
| United States, Arizona | |
| Barrow Neurological Institute | Recruiting |
| Phoenix, Arizona, United States, 85013 | |
| Contact: Mary Thornton 602-406-6287 mary.thornton@dignityhealth.org | |
| Principal Investigator: Aimee Borazanci, MD | |
| United States, Colorado | |
| UC Health Neurosciences Center | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Sama Kareem 720-472-2254 sama.kareem@cuanschutz.edu | |
| Principal Investigator: Amanda Piquet, MD | |
| United States, Florida | |
| Aqualane Clinical Research | Recruiting |
| Naples, Florida, United States, 34105 | |
| Contact: Daniela Gonzalez 239-434-0332 Daniela@aqualanersearch.com | |
| Contact: Kelly Calistri Kelly@aqualaneresearch.com | |
| Principal Investigator: Matthew Baker, MD | |
| University of South Florida - Neurology | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Amber McPherson 813-974-2423 amjackson@usf.edu | |
| Principal Investigator: Derrick Robertson, MD | |
| United States, Kansas | |
| University of Kansas Lander Center on Aging/ Neurology | Recruiting |
| Kansas City, Kansas, United States, 66103 | |
| Contact: Lisa Schmidt 913-588-1227 lschmidt@kumc.edu | |
| Principal Investigator: Sharon G Lynch, MD | |
| United States, Louisiana | |
| Ochsner Clinic Foundation | Recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| Contact: Maya Friedman 504-843-4819 maya.friedman@ochsner.org | |
| Principal Investigator: Jenny Feng, MD | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Leah Tardivo 216-445-5788 tardivl@ccf.org | |
| Principal Investigator: Jeffrey Cohen, MD | |
| United States, Pennsylvania | |
| Jefferson University Hospitals | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Angira Mathur 215-955-5765 angira.mathur@jefferson.edu | |
| Principal Investigator: Thomas P Leist, MD | |
| United States, South Carolina | |
| First Care Research Center | Recruiting |
| Columbia, South Carolina, United States, 29205 | |
| Contact: Sandra Arinze 774-271-4194 sarinze@firstcareresearchcenter.com | |
| Principal Investigator: Eleanya Ogburu-Ogbonnaya, MD | |
| United States, Tennessee | |
| Advanced Neurosciences Institute | Recruiting |
| Franklin, Tennessee, United States, 37064 | |
| Contact: Samuel Hunter, MD 615-791-5470 FrontOffice@neurosci.us | |
| United States, Texas | |
| University of Texas Southwestern | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Taylor Quance 214-645-3230 Taylor.Quance@UTSouthwestern.edu | |
| Principal Investigator: Benjamin Greenberg, MD | |
| University of Texas Health Science Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Jim Jemelka 713-704-4137 James.R.Jemelka@uth.tmc.edu | |
| Contact: Theresa Dancsak Theresa.Dancsak@uth.tmc.edu | |
| Principal Investigator: John W Lindsey, MD | |
| United States, Virginia | |
| MS Center of Greater Washington | Recruiting |
| Vienna, Virginia, United States, 22180 | |
| Contact: Rebeca Marin 703-226-4030 mscentercoordinator@gmail.com | |
| Principal Investigator: Heidi Crayton, MD | |
| United States, Washington | |
| MultiCare Health System | Recruiting |
| Tacoma, Washington, United States, 98405 | |
| Contact: Tonya Stigger 253-403-1208 tstigger@multicare.org | |
| Principal Investigator: Stacy Donlon, MD | |
Sponsors and Collaborators
Anokion SA
| Responsible Party: | Anokion SA |
| ClinicalTrials.gov Identifier: | NCT04602390 |
| Other Study ID Numbers: |
ANK-700-01 |
| First Posted: | October 26, 2020 Key Record Dates |
| Last Update Posted: | December 15, 2022 |
| Last Verified: | December 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Anokion SA:
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Autoimmune Multiple Sclerosis (MS) Relapsing Remitting MS |
Additional relevant MeSH terms:
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Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS |
Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |