Health Trials

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

ConditionSecondary Progressive Multiple Sclerosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorZenas BioPharma (USA), LLC

About this trial

Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 to 60 years of age, inclusive, at the time of signing the informed consent.

Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria

Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013

Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before screening. A written summary of the clinical evidence of disability progression must be discussed and aligned between the Investigator and the Sponsor's dedicated qualified person(s).

Disqualifiers

The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria

Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy.

History or current diagnosis of other neurological disorders that may mimic MS

History or current diagnosis of progressive multifocal leukoencephalopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Orelabrutinib

    Drug

    Orelabrutinib orally

  • Placebo

    Drug

    Placebo orally

Treatment groups

990 Participants
are divided into 2 treatment groups
Group A: Orelabrutinib GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 weeks

Expanded disability status scale (EDSS) score increase ≥ 1.0 point from baseline when the baseline score is ≤ 5.0, or ≥ 0.5 points from baseline when the baseline score is \> 5.0

Time frame
Up to approximately 120 weeks

Secondary outcomes

1

12 Week CDP

Time to onset of CDP events on EDSS, confirmed over at least 12 weeks

Time frame
Up to approximately 120 weeks
2

T2 lesions on MRI

The total number of new or enlarging T2 lesions on MRI scans of the brain

Time frame
Up to approximately 120 weeks
3

24-week CDP-9-hole Peg Test

Time to onset of CDP events on 9-hole Peg Test (9HPT), defined as ≥ 20% increase on 9HPT from baseline, confirmed over at least 24 weeks

Time frame
Up to approximately 120 weeks
4

24-week CDP-T25FWT

Time to onset of CDP events on Timed 25-Foot Walk Test (T25FWT), defined as ≥ 20% increase on T25FWT from baseline, confirmed over at least 24 weeks

Time frame
Up to approximately 120 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zenas BioPharma (USA), LLC

Lead sponsor

Source ClinicalTrials.gov
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