Phase 1
N=34
Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis (MS) · Relapsing Remitting Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT04602390 ↗Enrolled (actual)
34
Serious AEs
8.8%
Results posted
May 2025
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 2; 1; 3; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- ANK-700 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Anokion SA
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
2; 1; 3; 9; 6; 6 | — |
| SECONDARY CMAX |
NA; 7120.7; NA; 800.28; 3816; 540.99 | — |
| SECONDARY AUC Last |
NA; 3620; NA; 309; 1620; 217 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT04602390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.