Printed from Voxsanity (voxsanity.com.au) — NCT07029867 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Multiple Sclerosis Trial, Not Yet Recruiting
NCT07029867
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- Adults between 18 and 55 years old at the time of signing the consent form, of any gender.
- People who have been diagnosed with multiple sclerosis (MS) according to recognised 2017 and 2023 diagnostic guidelines.
- People who have not had a relapse (a flare-up of symptoms) for at least 30 days before the screening and first study visit, and whose neurological function has been stable.
- People who have had at least one relapse with supporting evidence in the two years before screening — either one relapse within the past year, or at least one area of active inflammation visible on a specific type of MRI scan (gadolinium-enhanced T1 lesion) within the past six months.
- People whose MS-related disability level, measured by a standard scale called the EDSS, falls between 0 and 5.5 at screening and the first study visit — though people with a score of 2 or below may only be considered if their MS was diagnosed within the last 10 years.
- Women who are capable of becoming pregnant must have a negative pregnancy test result during screening, taken before the first dose of study medication.
- People who have read and fully understood all relevant information about the trial and have signed a consent form agreeing to follow the study requirements.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People diagnosed with a progressive form of MS, including primary progressive MS (PPMS) or secondary progressive MS (SPMS), based on recognised diagnostic guidelines.
- People with an EDSS disability score of 2.0 or below who have had MS for more than 10 years at the time of screening.
- People who have been diagnosed with an immune system disease other than MS, or any condition that requires them to take steroid medications by mouth, through a drip, or by injection — except for well-controlled type 2 diabetes or thyroid disease.
- People with active or serious infections (such as viral, bacterial, tuberculosis, or fungal), anyone who needed hospitalisation or intravenous antibiotics for an infection in the four weeks before screening, anyone who has had close contact with someone with an active infectious disease such as tuberculosis, anyone who has tested positive for HIV either previously or at screening, and anyone who has tested positive for hepatitis C virus RNA or has a high level of hepatitis B virus DNA either previously or at screening.
- People who have had a serious or life-threatening bleeding event (such as haemophilia or other clotting disorders), or whose blood clotting test results (INR of 1.5 or above, or APTT more than 1.5 times the upper limit of the normal range) fall outside acceptable limits.
- People who have had a heart attack or stroke within six months before screening, who currently have active chest pain (angina), or who have a history of significant heart failure (classified as NYHA Class III or IV); also, people with long-term uncontrolled high blood pressure (systolic 160 mmHg or above and/or diastolic 100 mmHg or above), abnormal heart rhythm test (ECG) results, or other significant active medical conditions that the research team considers would affect participation.
- People who have other clinically significant abnormalities considered important by the research team, or who have had major surgery within the two months before screening.
- People who have experienced severe depression in the six months before screening, or who are unable to complete the study due to a mental illness, cognitive difficulties, or emotional disorder.
- People with a history of cancer (unless considered fully cured for more than five years), or any other illness where life expectancy is less than one year.
- Women who are pregnant or breastfeeding, or women of childbearing potential who have a negative pregnancy test at screening but are not willing to use effective contraception throughout the study.
- People whose kidneys are not functioning well enough (eGFR below 30 mL/min/1.73 m²), or who have a kidney condition that makes the use of gadolinium contrast dye unsafe, such as acute kidney injury (confirm with trial site).
- People whose liver enzyme levels (ALT and AST) are more than twice the upper limit of normal, whose total bilirubin is more than 1.5 times the upper limit of normal, or who have other clinically significant abnormal blood test results.
- People with significantly low blood cell counts, including low levels of neutrophils (below 1,500/mm³), platelets (below 75,000/mm³), lymphocytes (below 1,000/mm³), or white blood cells (below 3,500/mm³).
- People who are unable to have an MRI scan, including those with a known allergic reaction to gadolinium contrast dye, those with a pacemaker, or those with other reasons that make MRI unsafe.
- People who are known or suspected to be allergic to the study drug or any of its ingredients.
- People who have used any of the following treatments in the four weeks before being assigned to a study group: steroid injections or oral steroids, adrenocorticotropic hormone (ACTH), intravenous immunoglobulin, plasma exchange, immunoadsorption therapy, beta interferon, glatiramer acetate, fumarate-based medications (such as diimidazole fumarate or dimethyl fumarate), or teriflunomide.
- People who have used natalizumab or S1P receptor modulator medications (such as fingolimod, siponimod, or ozanimod) within 12 weeks before being assigned to a study group.
- People who have used any of the following treatments within 48 weeks before being assigned to a study group: daclizumab, BTK inhibitors, mitoxantrone, or immune cell-depleting therapies such as alemtuzumab, rituximab, ofatumumab, ocrelizumab, anti-CD4 preparations, cladribine, cyclophosphamide, azathioprine, full-body radiotherapy, bone marrow transplantation, or similar therapies.
- People who have been taking dalfampridine or fampridine (a walking aid medication) but have not been on a stable dose for at least 12 weeks before being assigned to a study group (confirm with trial site).
- People who have taken part in a clinical trial of another investigational (unapproved) drug within the past 48 weeks.
- People considered unsuitable for any other reason, as determined by the research team.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
Ying Gao
Registry
ClinicalTrials.gov
Start date
15 March 2026
Est. completion
31 October 2026
Primary endpoints
The proportion of patients without combined unique active lesions (CUALs) in 24W compared to baseline.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.