Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sc
A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- ANK-700
Placebo
- Placebo
Results by group
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Up to 1 year
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Part A SAD Cohort 1, 0.3 mg/kg ANK-700 | 2 Participants | 3 | |
| Part A SAD Cohort 2, 1.0 mg/kg ANK-700 | 1 Participants | 3 | |
| Part A SAD Cohort 3, 3.0 mg/kg ANK-700 | 3 Participants | 3 | |
| Part B MAD Cohort 4, 0.3 mg/kg ANK-700 | 9 Participants | 9 | |
| Part B MAD Cohort 5, 1.0 mg/kg ANK-700 | 6 Participants | 8 | |
| Part B MAD Cohort Placebo | 6 Participants | 8 | |
| Part A SAD Cohort 1, 0.3 mg/kg ANK-700 | 1 Participants | 3 | |
| Part A SAD Cohort 2, 1.0 mg/kg ANK-700 | 0 Participants | 3 | |
| Part A SAD Cohort 3, 3.0 mg/kg ANK-700 | 0 Participants | 3 | |
| Part B MAD Cohort 4, 0.3 mg/kg ANK-700 | 3 Participants | 9 | |
| Part B MAD Cohort 5, 1.0 mg/kg ANK-700 | 1 Participants | 8 | |
| Part B MAD Cohort Placebo | 1 Participants | 8 | |
| Part A SAD Cohort 1, 0.3 mg/kg ANK-700 | 1 Participants | 3 | |
| Part A SAD Cohort 2, 1.0 mg/kg ANK-700 | 0 Participants | 3 | |
| Part A SAD Cohort 3, 3.0 mg/kg ANK-700 | 0 Participants | 3 | |
| Part B MAD Cohort 4, 0.3 mg/kg ANK-700 | 1 Participants | 9 | |
| Part B MAD Cohort 5, 1.0 mg/kg ANK-700 | 1 Participants | 8 | |
| Part B MAD Cohort Placebo | 0 Participants | 8 | |
| Part A SAD Cohort 1, 0.3 mg/kg ANK-700 | 1 Participants | 3 | |
| Part A SAD Cohort 2, 1.0 mg/kg ANK-700 | 2 Participants | 3 | |
| Part A SAD Cohort 3, 3.0 mg/kg ANK-700 | 0 Participants | 3 | |
| Part B MAD Cohort 4, 0.3 mg/kg ANK-700 | 0 Participants | 9 | |
| Part B MAD Cohort 5, 1.0 mg/kg ANK-700 | 2 Participants | 8 | |
| Part B MAD Cohort Placebo | 2 Participants | 8 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| ANK-700 SAD Cohort 1, 0.3 mg/kg ANK-700 | 3 | 1 (33.3%) | 0 |
| ANK-700 SAD Cohort 2, 1.0 mg/kg ANK-700 | 3 | 0 (0.0%) | 0 |
| ANK-700 SAD Cohort 3, 3.0 mg/kg ANK-700 | 3 | 0 (0.0%) | 0 |
| MAD Cohort 4, 0.3 mg/kg ANK-700 | 9 | 1 (11.1%) | 0 |
| MAD Cohort 5, 1.0 mg/kg ANK-700 | 8 | 1 (12.5%) | 0 |
| MAD Cohort Placebo | 8 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Up to 1 year
Safety
Other measures (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,
How the body handles the medicineAUC 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
How the body handles the medicine
Who could take part
Relapsing MS · 18 to 60
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
Papers
Loading reviews and guidelines…
History
Started
Nov 2020
Main results due
Apr 2024
Finished
Apr 2024
Results posted
May 2025