A Phase IV Study of Dimethyl Fumarate Enteric-coated Capsules for Relapsing Multiple Sclerosis (RMS)

Not Applicable

Not yet recruiting

• Conditions: Relapsing Multiple Sclerosis
• Interventions: Drug: Dimethyl Fumarate Enteric-coated Capsules

• Registration Number: NCT07138833
• Lead Sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd.

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), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS).

The main questions it aims to answer are:

\[Question 1\] The efficacy of dimethyl fumarate enteric-coated capsules in the treatment of RMS.

\[Question 2\] The safety of dimethyl fumarate enteric-coated capsules in the treatment of RMS.

Participants will:

Eligible 50 RMS patients will orally take dimethyl fumarate enteric-coated capsules during treatment, with an initial dose of 120 mg twice daily for 7 days, followed by a maintenance dose of 240 mg twice daily for 48 weeks.

The annualized relapse rate (ARR) at Week 48 will be observed.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-17
• Study First Submitted QC: 2025-08-17
• Last Update Submitted: 2025-08-17
• Study First Posted: 2025-08-24
• Last Update Posted: 2025-08-24
• Study Start: 2025-09-01
• Primary Completion: 2028-04
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dimethyl Fumarate Group	Dimethyl Fumarate Enteric-coated Capsules	-

Primary Outcome Measures

Name	Time	Method
Annualized Relapse Rate at Week 48	48 weeks	The primary efficacy endpoint is the annualized relapse rate (ARR), calculated as total relapses divided by total patient-years of observation, measured at Week 48