RecruitingPhase 2NCT04625153

RC18 in Patients With Relapsing Remitting Multiple Sclerosis:a Phase II Trial

RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection in Patients With Relapsing Remitting Multiple Sclerosis:a Phase II Trial


Sponsor

RemeGen Co., Ltd.

Enrollment

30 participants

Start Date

May 13, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

To observe the safety and effectivity of a Recombinant Human B Lymphocyte Stimulator Receptor : Immunoglobulin G( IgG ) Fc Fusion Protein for injection (RC18) in patients with relapsing remitting multiple sclerosis, analyze the dose-response relationship and provide a dose basis for follow-up clinical trials.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This Phase II study is testing RC18 (telitacicept), a drug that reduces overactive immune responses, as a treatment for people with relapsing-remitting multiple sclerosis (RRMS) — the most common form of MS characterized by episodes of worsening symptoms followed by partial recovery. **You may be eligible if...** - You are between 18 and 55 years old - You have been diagnosed with relapsing-remitting multiple sclerosis (RRMS) based on 2017 McDonald criteria - You have had at least one relapse in the past year, or two relapses in the past two years, or active lesions on recent brain MRI - Your neurological symptoms have been stable for at least 30 days before joining the study - Your disability score (EDSS) is 5.5 or lower **You may NOT be eligible if...** - You cannot have an MRI or are allergic to MRI contrast agents - You have another autoimmune disease in addition to MS - You have active infections or a history of certain serious infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRC18 160mg

RC18 160mg is injected subcutaneously once a week for 48 times.

BIOLOGICALRC18 240mg

RC18 240mg is injected subcutaneously once a week for 48 times.


Locations(1)

the Third Affiliated Hospital,Sun Yat-Sen University

Guangzhou, Guangdong, China

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NCT04625153


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