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

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emerald Health Pharmaceuticals

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 relapsing 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 or failure to 1 or more treatments for MS due to intolerability;

• 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 Progressive Relapsing MS (PRMS) according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing secondary progressive multiple sclerosis (SPMS);

• Relapse during the 28 days prior to first investigational product administration;

• History of clinically significant and uncontrolled medical condition that would preclude participation in a clinical trial;

• Participant has received the following:

1. Total lymphoid irradiation, T-cell or T-cell receptor vaccination, total body irradiation, or total lymphoid irradiation at any time;

2. Treatment with dalfampridine or fampridine unless on stable dose for ≥ 30 days;

3. Mitoxantrone or other immunosuppressant agents (e.g., cyclosporine, cyclophosphamide, methotrexate, mycophenolate) within 1 year prior to first investigational product administration;

4. Teriflunomide, unless discontinued by natural wash-out or patient agrees to subsequent cholestyramine or activated charcoal wash-out and exhibits no active agent in serum levels 12 days prior to first investigational product administration;

5. Dimethyl-fumarate within 60 days prior to first investigational product administration (if stopped, lymphocyte counts must be > 1 × 10^3/μL prior to dose);

6. Alemtuzumab or cladribine at any time;

7. Natalizumab 12 weeks prior to first investigational product administration;

8. CD20 depletion therapies such as rituximab, ocrelizumab, ofatumumab or others within 36 weeks prior to first investigational product administration. Condition for inclusion of such patients is that there is no complete B cell depletion and possible safety risk to patients based on the Investigator's opinion;

9. S1P receptor modulators (e.g., fingolimod) within 6 weeks prior to first investigational product administration;

10. Glatiramer acetate or interferons within 12 weeks prior to first investigational product administration;

11. Steroids or intravenous immunoglobulin within 4 weeks prior to first investigational product administration;

• 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 normal limit;

5. Total bilirubin ≥ 1.5 x upper limit of normal unless pattern consistent with Gilbert syndrome;

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 CKD-EPI equation);

8. Lymphocytes < 1 × 10^3/μL;