Status:
NOT_YET_RECRUITING
A Phase IV Study of Dimethyl Fumarate Enteric-coated Capsules for Relapsing Multiple Sclerosis (RMS)
Lead Sponsor:
Qilu Pharmaceutical (Hainan) Co., Ltd.
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to evaluate the efficacy and safety\] in \[subjects diagnosed with RMS according to the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsi...
Eligibility Criteria
Inclusion
- Confirmed RMS per the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS)
- At least one documented relapse within 12 months prior to screening; plus evidence of MS-consistent lesions on prior brain MRI or gadolinium-enhancing (GdE) lesions on an MRI performed within 6 weeks before screening
- Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0 (inclusive) at screening
Exclusion
- History or current diagnosis of malignancy (except fully resected basal cell carcinoma), or uncontrolled severe diseases of major organ systems (e.g., cardiac, renal, hepatic, neurological \[excluding multiple sclerosis\]) that, in the investigator's assessment, pose a significant risk to the subject or could confound study results.
- Protocol-defined multiple sclerosis (MS) relapse within 30 days prior to screening, or failure to achieve clinical stability from a prior relapse.
- History of suicidal behavior within 5 years prior to screening. Suicidal ideation (indicated by a "Yes" response to Item 4 or 5 on the C-SSRS) within 6 months prior to screening.Subjects with a history of suicidal behavior occurring \>5 years prior to screening require investigator assessment of eligibility.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07138833
Start Date
September 1 2025
End Date
August 1 2028
Last Update
August 24 2025
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