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A Phase IV Study of Dimethyl Fumarate Enteric-coated Capsules for Relapsing Multiple Sclerosis (RMS) | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE4

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

A Multicenter, Open-label, Single Group, Phase 4 Study to Evaluate Dimethyl Fumarate Enteric-coated Capsules in Relapsing Multiple Sclerosis (RMS)

NCT07138833•Qilu Pharmaceutical (Hainan) Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Key Dates

Start Date

September 1, 2025

Primary Completion Date

April 1, 2028

Completion Date

August 1, 2028

Last Updated

August 24, 2025

Enrollment

ESTIMATED participants

Conditions

Relapsing Multiple Sclerosis

Interventions

Dimethyl Fumarate Enteric-coated Capsules

DRUG

Contacts

Junwei Hao, doctor

CONTACT

010-83198082 haojunwei@vip.163.com

Cognitive Performance, Sleep Disturbances and Fatigue in Multiple Sclerosis

NCT07426991

Multiple SclerosisRemitting-Relapsing Multiple Sclerosis+4 more

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NCT06433752

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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