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A Phase 3 Study of Orelabrutinib in Non-active Secondary Progressive Multiple Sclerosis
EU CTIS ID: 2025-524322-18-00
What this study is testing
To evaluate the efficacy of orelabrutinib compared to placebo in delaying disability progression in naSPMS
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1) Participants are eligible to be included in the study only if all the following criteria apply: 18 to 60 years of age, inclusive, at the time of signing the informed consent.
- 2) Participants are eligible to be included in the study only if all the following criteria apply: Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald Criteria.
- 3) Participants are eligible to be included in the study only if all the following criteria apply: Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013
- 4) Participants are eligible to be included in the study only if all the following criteria apply: 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).
- 5) Participants are eligible to be included in the study only if all the following criteria apply: Absence of clinical relapses for at least 24 months.
- 6) Participants are eligible to be included in the study only if all the following criteria apply: Absence of GdE T1 brain lesions as measured by MRI at screening.
You likely can't join if
- 1. Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)
- 2. Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy
- 3. History or current diagnosis of other neurological disorders that may mimic MS
- 4. History of any other significant active medical condition
See the full eligibility criteria
- 1) Participants are eligible to be included in the study only if all the following criteria apply: 18 to 60 years of age, inclusive, at the time of signing the informed consent.
- 2) Participants are eligible to be included in the study only if all the following criteria apply: Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald Criteria.
- 3) Participants are eligible to be included in the study only if all the following criteria apply: Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013
- 4) Participants are eligible to be included in the study only if all the following criteria apply: 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).
- 5) Participants are eligible to be included in the study only if all the following criteria apply: Absence of clinical relapses for at least 24 months.
- 6) Participants are eligible to be included in the study only if all the following criteria apply: Absence of GdE T1 brain lesions as measured by MRI at screening.
- 7) Participants are eligible to be included in the study only if all the following criteria apply: Absence of GdE T1 brain lesions as measured by MRI for at least 12 months only applicable if an MRI is available.
- 8) Participants are eligible to be included in the study only if all the following criteria apply: EDSS score between 3.0 to 6.5 points, inclusive, at Screening
- 1. Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)
- 2. Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy
- 3. History or current diagnosis of other neurological disorders that may mimic MS
- 4. History of any other significant active medical condition
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Mexico
- Brazil
- India
- Colombia
- Ukraine
- United States
- Argentina
- Georgia
- Australia
- Peru
- Israel
- Chile
- Serbia
- Canada
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Mexico; Brazil; India; Colombia; Ukraine and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.