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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04909502




Registration number
NCT04909502
Ethics application status
Date submitted
14/05/2021
Date registered
1/06/2021
Date last updated
21/10/2022

Titles & IDs
Public title
Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Relapsing Forms of Multiple Sclerosis
Scientific title
A Phase IIa, Open-label, Multicentre Dose-Finding Trial in Patients With Relapsing Forms of Multiple Sclerosis (RMS) to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101
Secondary ID [1] 0 0
EHP-101-MS02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Forms of Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EHP-101 25 mg OD
Treatment: Drugs - EHP-101 25 mg BID
Treatment: Drugs - EHP-101 50 mg OD
Treatment: Drugs - EHP-101 50 mg BID

Experimental: EHP-101 Once a day (OD) -

Experimental: EHP-101 Twice a day (BID) -


Treatment: Drugs: EHP-101 25 mg OD
25 mg OD during the first 28 Days of the trial

Treatment: Drugs: EHP-101 25 mg BID
25 mg BID during the first 28 Days of the trial

Treatment: Drugs: 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

Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of Treatment Emergent Adverse Events
Timepoint [1] 0 0
168 days (24 weeks)
Secondary outcome [1] 0 0
Brain lesion activity measured by MRI
Timepoint [1] 0 0
168 days (24 weeks)
Secondary outcome [2] 0 0
Disease progression measured by MS Functional Composite (MSFC)
Timepoint [2] 0 0
168 days (24 weeks)
Secondary outcome [3] 0 0
Disease progression measured by Expanded Disability Status Scale (EDSS)
Timepoint [3] 0 0
168 days (24 weeks)
Secondary outcome [4] 0 0
Disease progression measured by Symbol Digit Modalities Test (SDMT)
Timepoint [4] 0 0
168 days (24 weeks)
Secondary outcome [5] 0 0
Disability status measured by MS Functional Composite (MSFC)
Timepoint [5] 0 0
168 days (24 weeks)
Secondary outcome [6] 0 0
Disability status measured by Expanded Disability Status Scale (EDSS)
Timepoint [6] 0 0
168 days (24 weeks)
Secondary outcome [7] 0 0
Disability status measured by Symbol Digit Modalities Test (SDMT)
Timepoint [7] 0 0
168 days (24 weeks)
Secondary outcome [8] 0 0
Time to first relapse
Timepoint [8] 0 0
168 days (24 weeks)
Secondary outcome [9] 0 0
Preliminary Annualized Relapse Rate (ARR)
Timepoint [9] 0 0
168 days (24 weeks)
Secondary outcome [10] 0 0
Percent of patients who experience a relapse
Timepoint [10] 0 0
168 days (24 weeks)
Secondary outcome [11] 0 0
Proportion of patients who remain qualified as relapse-free
Timepoint [11] 0 0
168 days (24 weeks)
Secondary outcome [12] 0 0
Change in blood levels of neurofilament light chain (NfL)
Timepoint [12] 0 0
Baseline, 28 Days, 56 Days, 84 Days, 112 Days, 140 Days, 168 Days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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;

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Emerald Health Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT04909502
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04909502