Relapsing Forms of Multiple SclerosisPhase 2NCT04909502
Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Relapsing Forms of Multiple Sclerosis
A Phase 2 study testing EHP-101 25 mg OD, EHP-101 25 mg BID and EHP-101 50 mg OD in people with Relapsing Forms of Multiple Sclerosis, run by Emerald Health Pharmaceuticals at 4 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Forms of Multiple Sclerosis
- What is being tested?
- EHP-101 25 mg OD, EHP-101 25 mg BID and EHP-101 50 mg OD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 19 Oct 2021to Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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:
- 52 weeks or less prior to first investigational product administration: Immunosuppressant agents (e.g., cyclosporine, methotrexate, mycophenolate)
Show all 20Show fewer
- 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.
- 12 weeks or less prior to first investigational product administration: natalizumab
- 8 weeks or less prior to first investigational product administration: dimethyl-fumarate fingolimod
- 4 weeks or less prior to first investigational product administration: corticosteroids intravenous immunoglobulin (IVIG) ozanimod, siponimod, or ponesimod glatiramer acetate interferons
- 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:
- 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;
- Total bilirubin ≥ 1.5 x upper limit of normal;
- Thyroid-stimulating hormone level >10% above of the upper limit of normal;
- Estimated glomerular filtration rate ≤60 mL/min/1.73m2 (using the Cockcroft-Gault equation);
- Lymphocytes < 1 × 10^9/L;
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
North Central Neurology Associates
Cullman, Alabama, 35058
Fullerton Neurology and Headache Center
Fullerton, California, 92835
Accel Research Sites - Brain and Spine Institute of Port Orange
Port Orange, Florida, 32127
About this study
Official 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
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).
Read the 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
- Being tested
- EHP-101 25 mg OD, EHP-101 25 mg BID, EHP-101 50 mg OD, EHP-101 50 mg BID
- 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
- Medical subject headings
- Multiple Sclerosis, Nervous System Diseases, Autoimmune Diseases of the Nervous System, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHP-101 25 mg ODDrug
25 mg OD during the first 28 Days of the trial
EHP-101 25 mg BIDDrug
25 mg BID during the first 28 Days of the trial
EHP-101 50 mg ODDrug
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 50 mg BIDDrug
After 28 Days of treatment with 25 mg BID, patients will escalate to 50 mg BID up to the end of the trial
| Study group | Role | What they receive |
|---|---|---|
| EHP-101 Once a day (OD) | Experimental | Not described Receives: Drug: EHP-101 25 mg OD; Drug: EHP-101 50 mg OD |
| EHP-101 Twice a day (BID) | Experimental | Not described Receives: Drug: EHP-101 25 mg BID; Drug: EHP-101 50 mg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 168 days (24 weeks)
Secondary outcomes (12)
Brain lesion activity measured by MRI
Measured: 168 days (24 weeks)
Disease progression measured by MS Functional Composite (MSFC)
The MSFC consists of three assessments of walking speed, processing speed and finger dexterity. The scores are combined to provide a Z-score (number of standard deviations away from mean of a normal population) with lower scores representing greater abnormality
Measured: 168 days (24 weeks)
Disease progression measured by Expanded Disability Status Scale (EDSS)
The EDSS is an ordinal scale used for assessing neurological impairment of MS based on a neurological examination. It consists of scores in each of seven functional systems (FS) and an ambulation score that are then combined to determine the EDSS [ranging from 0 (normal) to 10 (death due to MS)]. The FSs are the Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel \& Bladder, and Cerebral functions. The FSs and EDSS steps will be assessed in a standardized manner
Measured: 168 days (24 weeks)
Disease progression measured by Symbol Digit Modalities Test (SDMT)
The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution
Measured: 168 days (24 weeks)
Disability status measured by MS Functional Composite (MSFC)
The MSFC consists of three assessments of walking speed, processing speed and finger dexterity. The scores are combined to provide a Z-score (number of standard deviations away from mean of a normal population) with lower scores representing greater abnormality
Measured: 168 days (24 weeks)
Disability status measured by Expanded Disability Status Scale (EDSS)
The EDSS is an ordinal scale used for assessing neurological impairment of MS based on a neurological examination. It consists of scores in each of seven functional systems (FS) and an ambulation score that are then combined to determine the EDSS [ranging from 0 (normal) to 10 (death due to MS)]. The FSs are the Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel \& Bladder, and Cerebral functions. The FSs and EDSS steps will be assessed in a standardized manner
Measured: 168 days (24 weeks)
Disability status measured by Symbol Digit Modalities Test (SDMT)
The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution
Measured: 168 days (24 weeks)
Time to first relapse
Measured: 168 days (24 weeks)
Preliminary Annualized Relapse Rate (ARR)
Measured: 168 days (24 weeks)
Percent of patients who experience a relapse
Measured: 168 days (24 weeks)
Proportion of patients who remain qualified as relapse-free
Measured: 168 days (24 weeks)
Change in blood levels of neurofilament light chain (NfL)
Measured: Baseline, 28 Days, 56 Days, 84 Days, 112 Days, 140 Days, 168 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start19 Oct 2021
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Why it stopped: Temporary recruitment pause to re-assess the protocol design, specifically the eligibility criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Forms of Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emerald Health Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909502
- Sponsor's protocol ID
- EHP-101-MS02
- Status last verified
- Apr 2022
- First submitted
- 14 May 2021
- Last updated
- 21 Oct 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04909502
- Acronym / sponsor ID
- EHP-101-MS02
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Temporary recruitment pause to re-assess the protocol design, specifically the eligibility criteria
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Emerald Health PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (20 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EHP-101 25 mg OD25 mg OD during the first 28 Days of the trial | Drug | EHP-101 Once a day (OD) |
| EHP-101 25 mg BID25 mg BID during the first 28 Days of the trial | Drug | EHP-101 Twice a day (BID) |
| EHP-101 50 mg ODAfter 28 Days of treatment with 25 mg OD, patients will escalate to 50 mg OD up to the end of the trial | Drug | EHP-101 Once a day (OD) |
| EHP-101 50 mg BIDAfter 28 Days of treatment with 25 mg BID, patients will escalate to 50 mg BID up to the end of the trial | Drug | EHP-101 Twice a day (BID) |
Primary outcome
Incidence and severity of Treatment Emergent Adverse Events
Time frame: 168 days (24 weeks)
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
12 secondary outcomes
Brain lesion activity measured by MRI
Time frame: 168 days (24 weeks)
Disease progression measured by MS Functional Composite (MSFC)
Time frame: 168 days (24 weeks)
Disease progression measured by Expanded Disability Status Scale (EDSS)
Time frame: 168 days (24 weeks)
Disease progression measured by Symbol Digit Modalities Test (SDMT)
Time frame: 168 days (24 weeks)
Disability status measured by MS Functional Composite (MSFC)
Time frame: 168 days (24 weeks)
Disability status measured by Expanded Disability Status Scale (EDSS)
Time frame: 168 days (24 weeks)
Disability status measured by Symbol Digit Modalities Test (SDMT)
Time frame: 168 days (24 weeks)
Time to first relapse
Time frame: 168 days (24 weeks)
Preliminary Annualized Relapse Rate (ARR)
Time frame: 168 days (24 weeks)
Percent of patients who experience a relapse
Time frame: 168 days (24 weeks)
Proportion of patients who remain qualified as relapse-free
Time frame: 168 days (24 weeks)
Change in blood levels of neurofilament light chain (NfL)
Time frame: Baseline, 28 Days, 56 Days, 84 Days, 112 Days, 140 Days, 168 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EHP-101 25 mg OD, EHP-101 25 mg BID and EHP-101 50 mg OD in people with Relapsing Forms of Multiple Sclerosis, run by Emerald Health Pharmaceuticals at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Treatment Emergent Adverse Events (time frame: 168 days (24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.