Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Relapsing Forms of Multiple Sclerosis

NCT04909502 | Suspended Phase 2 FDA Drug

• 1 other identifier: EHP-101-MS02
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 4

Brief Summary

The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in adult subjects with Relapsing Forms of Multiple Sclerosis (RMS).

Conditions

Relapsing Forms of Multiple Sclerosis

Keywords

Multiple Sclerosis; Nervous System Diseases; Demyelinating Autoimmune Diseases; Autoimmune Diseases of the Nervous System; Relapsing Forms of Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis; Relapsing Secondary Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of Treatment Emergent Adverse Events

  This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments

  168 days (24 weeks)

Secondary Outcomes (12)

• Brain lesion activity measured by MRI

  168 days (24 weeks)

• Disease progression measured by MS Functional Composite (MSFC)

  168 days (24 weeks)

• Disease progression measured by Expanded Disability Status Scale (EDSS)

  168 days (24 weeks)

• Disease progression measured by Symbol Digit Modalities Test (SDMT)

  168 days (24 weeks)

• Disability status measured by MS Functional Composite (MSFC)

  168 days (24 weeks)

Other Outcomes (5)

• Microstructural analysis and assessment of potential remyelination measured by Magnetization Transfer Ratio (MTR)

  168 days (24 weeks)

• Assessment of white matter diffusivity and integrity measured by Diffusion Tensor Imaging (DTI)

  168 days (24 weeks)

• VCE-004.8 plasma trough levels for all patients

  197 Days (28 weeks)

Study Arms (2)

EHP-101 Once a day (OD)

EXPERIMENTAL

Drug: EHP-101 25 mg OD; Drug: EHP-101 50 mg OD

EHP-101 Twice a day (BID)

EXPERIMENTAL

Drug: EHP-101 25 mg BID; Drug: EHP-101 50 mg BID

Interventions

EHP-101 25 mg OD DRUG

25 mg OD during the first 28 Days of the trial

EHP-101 Once a day (OD)

EHP-101 25 mg BID DRUG

25 mg BID during the first 28 Days of the trial

EHP-101 Twice a day (BID)

EHP-101 50 mg OD DRUG

After 28 Days of treatment with 25 mg OD, patients will escalate to 50 mg OD up to the end of the trial

EHP-101 Once a day (OD)

EHP-101 50 mg BID DRUG

After 28 Days of treatment with 25 mg BID, patients will escalate to 50 mg BID up to the end of the trial

EHP-101 Twice a day (BID)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female adults aged 18 to 55 years at the time of consent;
• Confirmed diagnosis of MS according to the revised 2017 McDonald criteria;
• Relapsing forms of MS (RMS) including Relapsing-Remitting MS (RRMS) and active Secondary Progressive MS (SPMS);
• Patients must have experienced at least 1 of the following within 12 months prior to Visit 1: an acute clinical relapse, gadolinium-enhancing T1 lesions on brain or spinal cord magnetic resonance imaging (MRI), or new T2 lesion(s) on brain or spinal cord MRI;
• Neurologically stable with no evidence of clinical relapse of MS or corticosteroid treatment within 28 days prior to the first investigational product administration;
• Naïve to prior MS treatment or discontinuing current MS treatment due to (1) intolerability, (2) laboratory abnormalities, (3) current treatment perceived by the patient to be ineffective, (4) patient preference, or (5) based on investigator judgement to switch MS therapy;
• An EDSS score of 0 to 6.0 (inclusive) at screening and enrolment visit;
• Willing and able to provide informed consent and capable of understanding and complying with the protocol.

You may not qualify if:

• Primary progressive MS (PPMS) or non-active secondary progressive MS (SPMS);
• Relapse during the 28 days prior to first investigational product administration;
• Total lymphoid irradiation, T-cell or T-cell receptor vaccination, total body irradiation, or total lymphoid irradiation at any time;
• Treatment with alemtuzumab, mitoxantrone, cyclophosphamide or cladribine at any time;
• MS treatment that may impact the efficacy or safety assessment defined as follows:
• weeks or less prior to first investigational product administration: Immunosuppressant agents (e.g., cyclosporine, methotrexate, mycophenolate)
• weeks or less prior to first investigational product administration: natalizumab
• weeks or less prior to first investigational product administration: dimethyl-fumarate fingolimod
• weeks or less prior to first investigational product administration: corticosteroids intravenous immunoglobulin (IVIG) ozanimod, siponimod, or ponesimod glatiramer acetate interferons
• weeks or less prior to first investigational product administration: teriflunomide. Subject must exhibit no active agent in serum levels; cholestyramine or activated charcoal washout may be used to achieve this;
• Any one of the following values for laboratory test at screening:
• Haemoglobin \< 9 g/dL;
• Neutrophils \< 1.0 x 10\^9/L;
• Platelets \< 75 x 10\^9/L;
• Serum transaminases \> 2.0 x upper limit of normal;

Sponsors & Collaborators

• Emerald Health Pharmaceuticals: lead

Study Sites (4)

North Central Neurology Associates

Cullman, Alabama, 35058, United States

Location

Fullerton Neurology and Headache Center

Fullerton, California, 92835, United States

Location

Accel Research Sites - Brain and Spine Institute of Port Orange

Port Orange, Florida, 32127, United States

Location

St. Vincent's Hospital

Melbourne, Victoria, 3065, Australia

Location

MeSH Terms

Conditions

Multiple Sclerosis; Nervous System Diseases; Autoimmune Diseases of the Nervous System; Multiple Sclerosis, Relapsing-Remitting

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open Label design
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will initially be conducted with 2 treatment arms starting in parallel. Patients will initially receive a 25 mg OD or a 25 mg BID dose. After 28 days, each patient will increase to a 50 mg OD or 50mg BID dose level, respectively, if deemed to be safe by the investigator.

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: June 1, 2021
• Study Start: October 19, 2021
• Primary Completion: December 1, 2023
• Study Completion: April 1, 2024
• Last Updated: October 21, 2022

Record last verified: 2022-04

Locations

US (3); AU (1)