Clinical trial NCT04602390: Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis (MS)
Relapsing Remitting Multiple Sclerosis
Keywords: Autoimmune
Multiple Sclerosis (MS)
Relapsing Remitting MS
Lead sponsor: Anokion SA
Sponsor class: INDUSTRY
First posted: 2020-10-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

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.

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

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 1 year
Secondary outcomes:
measure: CMAX
timeFrame: 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
measure: AUC Last
timeFrame: 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
Other outcomes:
Locations:
city: Cullman
country: United States
facility: North Central Neurology
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Aurora
country: United States
facility: UC Health Neurosciences Center
state: Colorado
city: Naples
country: United States
facility: Aqualane Clinical Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida - Neurology
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Lander Center on Aging/ Neurology
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Jefferson University Hospitals
state: Pennsylvania
city: Columbia
country: United States
facility: Midlands Neurology & Pain Associates PA
state: South Carolina
city: Franklin
country: United States
facility: Advanced Neurosciences Institute
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Vienna
country: United States
facility: MS Center of Greater Washington
state: Virginia
city: Tacoma
country: United States
facility: MultiCare Health System
state: Washington
Study officials:
References: