AzTrials
AzTrials

Multiple Sclerosis, Relapsing-RemittingPhase 2NCT04625153

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

A Phase 2 study testing RC18 160mg and RC18 240mg in people with Multiple Sclerosis, Relapsing-Remitting, run by RemeGen Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis, Relapsing-Remitting
What is being tested?
RC18 160mg and RC18 240mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteChina
Study dates
13 May 2021to 3 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with relapsing remitting multiple sclerosis meet the diagnostic criteria of McDonald 2017.
  • 18-55 years old, male or female
  • At least 1 recurrence was recorded within 1 year prior to randomization, or at least 2 recurrences within 2 years (the first clinical episode of MS was recorded as a recurrence), or active gadolinium enhanced lesions in the brain within 1 year prior to screening.
  • Neurological symptoms were stable for ≥30 days before screening and before baseline
  • EDSS score ≤ 5.5
  • Informed consent signed voluntarily

Who cannot join

  • Patients who were unable to undergo magnetic resonance imaging or who were allergic to gadolinium contrast agents during the trial
  • In addition to multiple sclerosis, patients with chronic active immune system diseases or who are stable but require immunotherapy (glucocorticoids and/or immunosuppressants) (e.g., rheumatoid arthritis, scleroderma, Sjogren's syndrome, Crohn's disease, ulcerative colitis), Or patients with known immunodeficiency syndromes (AIDS, genetic immunodeficiency, and drug-induced immunodeficiency); Patients who received glucocorticoid maintenance therapy before randomization could participate in the trial after discontinuing the drug.
  • Patients who were AQP4 antibody positive and/or MOG antibody positive within 1 year prior to randomization
  • Patients who have received the following treatment:
  • Interferon, pegylated interferon, glatirex acetate, and dimethyl fumarate were used within 4 weeks prior to randomization.
  • Use of Fingomod, intravenous immunoglobulin, or plasmapheresis within 12 weeks prior to randomization.
Show all 18Show fewer
  • Alemtuzumab, Daclizumab, Ocrelizumab were administered within 24 weeks prior to randomization.
  • Azathioprine (AZA, half-life t1/2=6hrs), Mycophenolate Mofetil (t1/2=16hrs), Leflunomide (LEF, LEflunomide) were used before randomization. t1/2=15 days), Tacrolimus (t1/2=43 hrs), Teriflunomide (t1/2=18 days), Cyclosporin (CsA) Patients with immunosuppressants such as t1/2=27 hrs), Methotrexate (MTX, t1/2=14hrs), Cyclophosphamide (CTX, t1/2=6hrs), in addition to leflunomide and teriflunomide, The discontinuation interval was more than 5 times the half-life. Leflunomide and Teriflunomide need to be eluted with coletenide, which can be discontinued and the following measures taken: Coletenide 8 g 3 times daily for 11 days, if the 8 g dose is not tolerated, can be changed to 4 g orally for the same time and frequency as before.
  • Use of clatribine or mitoxantrone within 1 year prior to randomization.
  • Received lymphoid irradiation and bone marrow transplantation before randomization.
  • Patients were participated in any clinical trial 28 days before randomization or within 5 times half-life of study drug participating in clinical trial (whichever is longer).
  • Patients with any persistent or chronic active infection or serious infection history in the screening period, such as shingles; active tuberculosis (patients with latent tuberculosis can participate in the test if they are given isoniazid and / or rifampin at the same time); HIV infection; syphilis antibody positive; HCV antibody positive; HBsAg positive; HBsAg negative but HBcAb positive, the HBV-DNA quantitative test is needed. If the HBV-DNA is positive, the patient should be excluded. If the HBV-DNA is negative, the patient can not be excluded.
  • The results of abnormal laboratory tests to be excluded include but are not limited to: Leukocyte count < 3 × 10~9 / L; neutrophil < 1.5 × 10~9 / L; hemoglobin < 85g / L; platelet count < 80 × 10~9 / L; serum creatinine > 1.5 × ULN, accompanied by creatinine clearance < 50ml / min (measured value, or calculated by Cockcroft Gault formula); total bilirubin > 1.5 × ULN; ALT > 3 × ULN; AST > 3 × ULN; alkaline phosphatase > 2 × ULN; IgG < lower limit of normal value; IgM < lower limit of normal value;
  • Cancer patients
  • Pregnant women, lactating women and patients with family planning during the trial
  • Patients with other mental disorders
  • Patients who experienced any of the following events within 12 weeks before randomization: myocardial infarction, unstable ischemic heart disease, stroke, or NYHA class IV heart failure
  • The researchers believe that the patients are compliant insufficiently or not suitable to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the Third Affiliated Hospital,Sun Yat-Sen University

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: 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

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.

Being tested
RC18 160mg, RC18 240mg
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RC18 160mgBiological

    Also called telitacicept

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

  • RC18 240mgBiological

    Also called telitacicept

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

Study groups in NCT04625153
Study groupRoleWhat they receive
RC18 160mgExperimentalRC18 160mg is injected subcutaneously once a week for 48 times.
Receives: Biological: RC18 160mg
RC18 240mgExperimentalRC18 240mg is injected subcutaneously once a week for 48 times.
Receives: Biological: RC18 240mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 48-week annual recurrence rate (ARR)

    48-week annual recurrence rate (ARR). ARR is calculated as the total number of relapses for all subjects divided by the total number of years of subjects receiving this treatment

    Measured: 0- 48 weeks

Secondary outcomes (7)

  1. 24 weeks confirmed disability progression

    Time to 24 weeks confirmed disability progression (24wCDP) (based on EDSS assessment)

    Measured: 0-24weeks

  2. 12 weeks confirmed disability progression

    Time to 12 weeks confirmed disability progression (12wCDP) (based on EDSS assessment)

    Measured: 0-12weeks

  3. 12 weeks confirmed disability improvement

    Time to 12 weeks confirmed disability improvement (12wCDI) (based on EDSS assessment)

    Measured: 0-12weeks

  4. Changes in EDSS scores from baseline at weeks 12, 24, 36 and 48

    Changes in EDSS scores from baseline at weeks 12, 24, 36 and 48; Gadolinium enhanced T1 lesion number in the brain compared with baseline at weeks 12, 24, 36, and 48

    Measured: At 12, 24, 36 and 48 weeks

  5. Number of new low-signaling T1 lesions in the brain

    Number of new low-signaling T1 lesions in the brain at weeks 12, 24, 36, and 48 compared with baseline

    Measured: At 12, 24, 36 and 48 weeks

  6. Number of new/new large T2 lesions in the brain

    Number of new/new large T2 lesions in the brain at weeks 12, 24, 36, and 48 compared with baseline

    Measured: At 12, 24, 36 and 48 weeks

  7. Proportion of patients without recurrence at weeks 0 to 48

    Proportion of patients without recurrence at weeks 0 to 48

    Measured: 0- 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2020
  2. Study start13 May 2021
  3. Primary completion3 Apr 2026
  4. Study completion3 Apr 2026

Why it stopped: Sponsor Strategic Priority Adjustment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04625153
Sponsor's protocol ID
18C013
Status last verified
Apr 2026
First submitted
6 Nov 2020
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RC18 160mg and RC18 240mg in people with Multiple Sclerosis, Relapsing-Remitting, run by RemeGen Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor Strategic Priority Adjustment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

48-week annual recurrence rate (ARR) (time frame: 0- 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04625153.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in