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

NCT ID: NCT04909502

Last Updated: 2022-10-21

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-19
• Study Completion Date: 2024-04-30

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).

Detailed Description

An interventional, open label, randomized design will be used to test safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in 50 patients ≥ 18 and ≤ 55 years of age with documented RMS. There will be a screening period of up to 28 days, 168 days treatment period, and 28 days follow-up.

Conditions

Relapsing Forms of Multiple Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EHP-101 Once a day (OD)

Group Type: EXPERIMENTAL

EHP-101 25 mg OD

Intervention Type: DRUG

25 mg OD during the first 28 Days of the trial

EHP-101 50 mg OD

Intervention Type: 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 Twice a day (BID)

Group Type: EXPERIMENTAL

EHP-101 25 mg BID

Intervention Type: DRUG

25 mg BID during the first 28 Days of the trial

EHP-101 50 mg BID

Intervention Type: DRUG

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

Interventions

EHP-101 25 mg OD

25 mg OD during the first 28 Days of the trial

Intervention Type: DRUG

EHP-101 25 mg BID

25 mg BID during the first 28 Days of the trial

Intervention Type: DRUG

EHP-101 50 mg OD

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

Intervention Type: DRUG

EHP-101 50 mg BID

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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:

1. 52 weeks or less prior to first investigational product administration: Immunosuppressant agents (e.g., cyclosporine, methotrexate, mycophenolate)

2. 36 weeks or less prior to first investigational product administration: CD20 depletion therapies such as rituximab, ocrelizumab, ofatumumab or others. Condition for inclusion of patients who had CD20 depletion therapies more than 36 weeks prior to the first investigational product administration: may only be included if there is no clinically relevant B cell depletion and possible safety risk to patients based on the Investigator's opinion.

3. 12 weeks or less prior to first investigational product administration: natalizumab

4. 8 weeks or less prior to first investigational product administration: dimethyl-fumarate fingolimod

5. 4 weeks or less prior to first investigational product administration: corticosteroids intravenous immunoglobulin (IVIG) ozanimod, siponimod, or ponesimod glatiramer acetate interferons

6. 2 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:

1. Haemoglobin < 9 g/dL;

2. Neutrophils < 1.0 x 10^9/L;

3. Platelets < 75 x 10^9/L;

4. Serum transaminases > 2.0 x upper limit of normal;

5. Total bilirubin ≥ 1.5 x upper limit of normal;

6. Thyroid-stimulating hormone level >10% above of the upper limit of normal;

7. Estimated glomerular filtration rate ≤60 mL/min/1.73m2 (using the Cockcroft-Gault equation);

8. Lymphocytes < 1 × 10^9/L;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emerald Health Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

North Central Neurology Associates

Cullman, Alabama, United States

Fullerton Neurology and Headache Center

Fullerton, California, United States

Accel Research Sites - Brain and Spine Institute of Port Orange

Port Orange, Florida, United States

St. Vincent's Hospital

Melbourne, Victoria, Australia

Countries

United States; Australia

Other Identifiers

EHP-101-MS02

Identifier Type: -

Identifier Source: org_study_id