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

Qilu Pharmaceutical

Status and phase

Not yet enrolling

Phase 4

Conditions

Relapsing Multiple Sclerosis

Treatments

Drug: Dimethyl Fumarate Enteric-coated Capsules

Study type

Interventional

Funder types

Industry

Identifiers

NCT07138833

QLG1031-401

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.