Multiple Sclerosis Trial, By Invitation NCT05162638 Sponsor: University of Pennsylvania Condition: Multiple Sclerosis
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Multiple Sclerosis Trial, By Invitation

NCT05162638
By Invitation Not Applicable

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

  • People must provide written agreement to take part before any assessments are done.
  • Adults between 18 and 40 years of age (inclusive) at the time of screening.
  • People who are able to understand English and can read and understand the consent form on their own or with help from research staff.
  • People who have not used systemic (whole-body) steroid medications in the past 4 weeks.
  • For people with MS: a diagnosis of MS confirmed using the 2017 Revised McDonald criteria.
  • For people with MS: the ability to undergo several MRI scans.
  • For people with MS: a disability score (called EDSS) of between 0 and 4 (inclusive) at the time of screening.
  • For people with MS: prior MS treatment limited to interferons and/or glatiramer acetate only, or no MS treatment at all to date.
  • For people with MS: neurological condition must have been stable in the month before the study procedure.

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 who the investigator believes may be unable or unwilling to follow the study requirements.
  • People diagnosed with primary progressive MS.
  • People who meet the criteria for a condition called neuromyelitis optica.
  • People who have had their MS diagnosis for more than 10 years.
  • People who are pregnant or currently breastfeeding.
  • People with an active chronic immune system disease other than MS (such as rheumatoid arthritis, Crohn's disease, or similar conditions), or with an immune deficiency condition, whether inherited or caused by medication.
  • People with an active bacterial, viral, or fungal infection, or who have been diagnosed with AIDS.
  • People with neurological symptoms that could suggest a serious brain infection called PML, or who have a confirmed PML diagnosis.
  • People considered at risk of developing or experiencing a return of syphilis or tuberculosis.
  • People with a history of heart or cardiovascular disease, or uncontrolled high blood pressure.
  • People with a history of diabetes.
  • People with a history of cancer (other than localised skin cancer) within the past 5 years.
  • People who have received a live or live-attenuated vaccine (such as for chickenpox or measles) within 2 months before the first study treatment.
  • People who have received a non-live vaccine within 2 weeks before the study procedure.
  • People who show blood test results at screening indicating active or chronic hepatitis B or C infection, based on specific markers (confirm with trial site for full details).
  • People currently taking another experimental drug, or who have done so within the past 30 days, or within a timeframe based on how long that drug stays active in the body — whichever is longest.
  • People whose blood test shows a neutrophil count (a type of white blood cell) below 750/mm³.
  • People whose haemoglobin level is below 10.0 g/dL.
  • People whose platelet count is below 100,000/mm³.
  • People whose blood clotting test result (PT or INR) is more than 1.5 times the upper limit of the normal range.

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.
Last synced 30 July 2026
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.

GP referral letter

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Trial details

Status
By Invitation
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
19 April 2022
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety and Tolerability; B Cells

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 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.

View original record on ClinicalTrials.gov