Health Trials

A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

ConditionMultiple Sclerosis (MS) Primary Progressive
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 PPMS. Patients will be treated for approximately 30 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 705 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

Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria

Participant must have documented evidence of disability progression observed during the 24 months before screening.

Expanded disability status scale (EDSS) score between 3.0 to 6.5 points, inclusive, at Screening.

Disqualifiers

Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)

Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy.

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

History of any other significant active medical condition

Trial design

Design model

Parallel

Treatments tested in this trial

  • Orelabrutinib

    Drug

    Orally

  • Placebo

    Drug

    Orally

Treatment groups

705 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 composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-week cCDP)

* 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, OR * ≥ 20% increase in the Timed 25-Foot Walk Test (T25FWT), OR * ≥ 20% increase in the 9-hole Peg Test (9HPT)

Time frame
Up to approximately 120 weeks

Secondary outcomes

1

Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 24 weeks (24-week cCDP)

Time frame
Up to approximately 120 weeks
2

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

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
3

MRI T2 lesion

The total number of new/enlarging T2 lesions on MRI scans of the brain from baseline to Week 120

Time frame
Up to approximately 120 weeks
4

12-week CDP

Time to onset of CDP, confirmed over at least 12 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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