Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
705 (estimated)
Sponsor
Zenas BioPharma (USA), LLC · Industry
Who this trial is looking for
This trial is looking for people with Primary Progressive Multiple Sclerosis (PPMS). Participants will take either the study drug orelabrutinib or a placebo for about 30 to 60 months, with at least 12 months of treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 60 years old.
I have been diagnosed with Primary Progressive MS.
I have evidence of disability progression in the last 24 months.
My EDSS score is between 3.0 and 6.5.
You may not be able to join if
I have been diagnosed with relapsing-remitting MS or secondary progressive MS.
I have an immunologic disorder other than MS.
I have a history of other neurological disorders that may mimic MS.
I have a history of significant active medical conditions.
I have had suicidal behavior in the past 6 months.
I have a history of cancer that recurred within the last 5 years.
I am taking anticoagulation or antiplatelet therapy.
I have a history of alcohol or drug abuse in the past 12 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 randomiz…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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) s…
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* History of suicidal behavior within 6 months prior to Screening
* Any prior history of malignancy if no recurrence within 5 years
* Patients on anticoagulation, or antiplatelet therapy will be excluded
* Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducerswithin 14 days
* Clinically significant laboratory abnormalities at Screening.
* Any allergy, contraindication, or inability to tolerate orelabrutinib or any of the excipients in the study intervention
* Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening
* History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.
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