Phase 3 Multiple Sclerosis Trial, Recruiting NCT07067463 Sponsor: Zenas BioPharma (USA), LLC Condition: Multiple Sclerosis
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Phase 3 Multiple Sclerosis Trial, Recruiting

NCT07067463
Recruiting Phase 3

Who may 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 might be able to join this trial:

  • People who are between 18 and 60 years old
  • People who have been diagnosed with Primary Progressive MS (PPMS) based on a specific set of medical guidelines called the 2017 McDonald criteria
  • People whose medical records show that their disability has been getting worse over the 24 months before joining the trial
  • People whose level of physical disability, as measured by a standard MS scale called the EDSS, falls between 3.0 and 6.5 at the time of screening

Who may not be able to join:

  • People diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)
  • People who have an immune system disorder other than MS, or any condition that requires regular steroid treatment taken by mouth, injection, or into a joint
  • People who have a history of, or have currently been diagnosed with, another neurological condition that could look similar to MS
  • People with a history of any other serious active medical condition
  • People who have had suicidal behaviour in the 6 months before screening
  • People with a history of cancer, unless there has been no recurrence within the past 5 years (confirm with trial site)
  • People currently taking blood-thinning or anti-clotting medications
  • People who have taken certain medications that strongly or moderately affect how the body processes drugs (known as CYP3A inhibitors or inducers) within the 14 days before joining
  • People with significant abnormal results on blood or other laboratory tests at screening
  • People who have a known allergy, medical reason not to take, or inability to tolerate the study drug (orelabrutinib) or any of its ingredients
  • People who have received a live or live-attenuated virus vaccine within one month before screening
  • People with a history of alcohol use disorder or drug abuse within the 12 months before screening

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 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 833-269-4696

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Zenas BioPharma (USA), LLC
Registry
ClinicalTrials.gov
Start date
23 March 2026
Est. completion
1 June 2030

Where this trial is recruiting

🇧🇬 Bulgaria 🇭🇷 Croatia 🇨🇿 Czechia 🇪🇪 Estonia 🇬🇪 Georgia 🇩🇪 Germany 🇮🇹 Italy 🇳🇱 Netherlands 🇵🇱 Poland 🇷🇸 Serbia 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-week cCDP)

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: 28 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