Multiple Sclerosis (MS)Phase 1MoveS-itNCT04602390
Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis
A Phase 1 study testing ANK-700 in people with Multiple Sclerosis (MS) and Relapsing Remitting Multiple Sclerosis, run by Anokion SA at 15 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis (MS), Relapsing Remitting Multiple Sclerosis
- What is being tested?
- ANK-700
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 15 sitesUnited States
- Study dates
- 6 Nov 2020to 23 Apr 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
UC Health Neurosciences Center
Aurora, Colorado, 80045
Cleveland Clinic
Cleveland, Ohio, 44195
Midlands Neurology & Pain Associates PA
Columbia, South Carolina, 29205
North Central Neurology
Cullman, Alabama, 35058
University of Texas Southwestern
Dallas, Texas, 75390
Advanced Neurosciences Institute
Franklin, Tennessee, 37064
University of Texas Health Science Center
Houston, Texas, 77030
University of Kansas Lander Center on Aging/ Neurology
Kansas City, Kansas, 66103
Aqualane Clinical Research
Naples, Florida, 34105
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Jefferson University Hospitals
Philadelphia, Pennsylvania, 19107
Barrow Neurological Institute
Phoenix, Arizona, 85013
MultiCare Health System
Tacoma, Washington, 98405
University of South Florida - Neurology
Tampa, Florida, 33612
MS Center of Greater Washington
Vienna, Virginia, 22180
About this study
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
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
Read the 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.
- Being tested
- ANK-700, Placebo
- Keywords
- Autoimmune, Multiple Sclerosis (MS), Relapsing Remitting MS
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANK-700Drug
Intravenous (IV) infusion
PlaceboDrug
Intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: ANK-700; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 1 year
Secondary outcomes (2)
CMAX
Geometric mean of maximum plasma concentration (Cmax)
Measured: 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
Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start6 Nov 2020
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anokion SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602390
- Sponsor's protocol ID
- ANK-700-01
- Acronym
- MoveS-it
- Status last verified
- May 2025
- First submitted
- 5 Oct 2020
- Last updated
- 31 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muhammad A, Xiao Y, Ahmad YM, Tang R, Zhang Y, Yuan Q, Xiao X. Reprogramming Pathogenic Immune Memory through Inverse Vaccination in Autoimmune Kidney Disease. J Am Soc Nephrol. 2026 Aug 1;37(8):1809-1812. doi: 10.1681/ASN.0000001070. Epub 2026 Feb 27. No abstract available.
PubMed 41758576
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04602390
- Acronym / sponsor ID
- MoveS-it / ANK-700-01
- Keywords
- Autoimmune, Multiple Sclerosis (MS), Relapsing Remitting MS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Anokion SAIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Posted 31 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ANK-700 SAD Cohort 1, 0.3 mg/kg ANK-700 | Experimental | Drug: ANK-700All enrolled patients will receive one dose of 0.3 mg/kg ANK-700 |
| ANK-700 SAD Cohort 2, 1.0 mg/kg ANK-700 | Experimental | Drug: ANK-700All enrolled patients will receive one dose of 1.0 mg/kg ANK-700 |
| ANK-700 SAD Cohort 3, 3.0 mg/kg ANK-700 | Experimental | Drug: ANK-700All enrolled patients will receive one dose of 3.0 mg/kg ANK-700 |
| MAD Cohort 4 0.3 mg/kg ANK-700 or Placebo | Experimental | Drug: ANK-700, Drug: PlaceboAll enrolled patients will receive three doses of 0.3 mg/kg ANK-700 or placebo |
| MAD Cohort 5 1.0 mg/kg ANK-700 or placebo | Experimental | Drug: ANK-700, Drug: PlaceboAll enrolled patients will receive three doses of 1.0 mg/kg ANK-700 or placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANK-700Intravenous (IV) infusion | Drug | 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 |
| PlaceboIntravenous (IV) infusion | Drug | MAD Cohort 4 0.3 mg/kg ANK-700 or Placebo, MAD Cohort 5 1.0 mg/kg ANK-700 or placebo |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 1 year
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
2 secondary outcomes
CMAX
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41758576Muhammad A, Xiao Y, Ahmad YM, Tang R, Zhang Y, Yuan Q, Xiao X. Reprogramming Pathogenic Immune Memory through Inverse Vaccination in Autoimmune Kidney Disease. J Am Soc Nephrol. 2026 Aug 1;37(8):1809-1812. doi: 10.1681/ASN.0000001070. Epub 2026 Feb 27. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ANK-700 in people with Multiple Sclerosis (MS) and Relapsing Remitting Multiple Sclerosis, run by Anokion SA at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04602390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.