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A Phase 3 Study of Orelabrutinib to Delay Disability Progression in Patients with Non‑Active Secondary Progressive Multiple Sclerosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Non-active Secondary Progressive Multiple Sclerosis, a form of multiple sclerosis where the disease has become steadily worse without new relapses. The investigational medication being tested is an oral tablet called Orelabrutinib, which is taken by mouth, and it will be compared with an identical looking placebo tablet.

The purpose of the study is to evaluate whether Orelabrutinib can delay the worsening of disability compared with placebo. Participants will receive the assigned tablet each day for several years and will attend regular clinic visits where their ability to perform everyday tasks is checked and brain scans using MRI are performed to look for new lesions. The study will track how long it takes before a confirmed increase in disability occurs and will record any safety concerns throughout the trial.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and baseline assessments

    After enrollment you will be assigned randomly to receive either orelabrutinib or a matching placebo tablet.

    Baseline assessments include a physical examination, disability scoring (edss), blood tests, and an mri scan of the brain.

  2. Step 2

    Start of study medication

    You will begin taking one 80 mg oral tablet each day.

    The tablet is taken by mouth with water, preferably at the same time each day.

    The medication will be continued for the duration of the study as directed by the trial team.

  3. Step 3

    Regular clinic visits

    You will attend scheduled visits every few months to monitor safety and effectiveness.

    At each visit blood samples will be collected, your disability level will be reassessed, and any side effects will be recorded.

  4. Step 4

    Periodic mri scans

    You will undergo mri scans of the brain at intervals defined by the study protocol to evaluate new or enlarging t2 lesions.

    The scans help determine the impact of the study medication on disease activity.

  5. Step 5

    Assessment of disability progression

    Your edss score will be measured at each visit to detect any confirmed disability progression.

    The primary outcome is the time until a confirmed progression lasting at least 24 weeks.

  6. Step 6

    Final study visit

    At the end of the trial you will have a comprehensive evaluation including a final mri scan, blood tests, and disability assessment.

    The data collected will be used to compare the effects of orelabrutinib with the placebo.

Who can join the trial?

8 criteria

  • Be between 18 and 60 years old when you sign the consent form.
  • Have a previous diagnosis of relapsing‑remitting multiple sclerosis (RRMS) that was made using the 2024 McDonald Criteria (a set of guidelines doctors use to confirm MS).
  • Currently be diagnosed with secondary progressive multiple sclerosis (SPMS) according to the clinical guidelines updated in 2013.
  • Show documented evidence that your disability has gotten worse over the past 24 months without any new relapses (new attacks of symptoms).
  • Have had no clinical relapses (no new attacks) for at least 24 months.
  • Have a brain MRI at screening that shows no gadolinium‑enhancing T1 lesions (no active spots that light up after a contrast injection).
  • If you have previous MRI scans, they must also show no gadolinium‑enhancing T1 lesions for at least 12 months before screening.
  • Your EDSS (Expanded Disability Status Scale) score must be between 3.0 and 6.5 at the time of screening, indicating a moderate level of disability.

Who cannot join the trial?

4 criteria

  • Having a type of multiple sclerosis called relapsing‑remitting MS (RRMS)—where symptoms flare up and then improve—or secondary progressive MS (SPMS)—where symptoms gradually get worse over time.
  • Having any other immune system disorder (a disease that affects the body’s defense system) or any condition that requires treatment with steroids such as pills, IV (intravenous), muscle injections, or joint injections (corticosteroid therapy).
  • Having a history of, or currently having, another brain or nerve disease that can look like multiple sclerosis (neurological disorders that may mimic MS).
  • Having any other serious ongoing medical illness (significant active medical condition).
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Investigated drugs

Orelabrutinib is an oral tablet that is being tested to see if it can slow down the worsening of disability in people with non‑active secondary progressive multiple sclerosis. In the study, participants take this medication by mouth, and researchers compare their health outcomes to those of participants who receive a placebo. The goal is to find out whether orelabrutinib can help delay the progression of the disease and improve patients’ quality of life.

What is already known about the treatment

  • Orelabrutinib

    Orelabrutinib is taken as an oral tablet taken by mouth once daily. It is an approved medicine for certain blood cancers and is now being studied in clinical trials for multiple sclerosis. The drug works by blocking a protein called Bruton’s tyrosine kinase, which reduces the activity of immune cells that can damage nerves. It belongs to the class of medicines known as BTK inhibitors, a type of small‑molecule drug.

  • Placebo

    The placebo is an inert tablet that looks exactly like the Orelabrutinib tablet but contains no active drug. It is used in the study to compare the effects of the real medicine with no treatment. Because it has no active ingredients, it does not have a therapeutic use or a mechanism of action. It is classified simply as a placebo control.

Investigated diseases

Secondary progressive multiple sclerosis (non‑active) - It is a stage of multiple sclerosis that follows an earlier relapsing phase and is marked by a steady worsening of disability without new inflammatory attacks. The disease slowly damages the protective coating of nerve fibers, causing slower transmission of nerve signals. Over time, individuals may notice increasing weakness, balance problems, and fatigue. The progression is continuous and is tracked by gradual changes in disability scores.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524322-18-00Protocol codeZB020-03-002Estimated enrolment1 100 patientsSponsorZenas Biopharma (USA) LLC

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