We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04625153
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
RemeGen Co., Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Biological: RC18 160mg Biological: RC18 240mg Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 2, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: RC18 160mg
RC18 160mg is injected subcutaneously once a week for 48 times.
 Biological: RC18 160mg
RC18 160mg is injected subcutaneously once a week for 48 times.
Other Name: telitacicept
Experimental: RC18 240mg
RC18 240mg is injected subcutaneously once a week for 48 times.
 Biological: RC18 240mg
RC18 240mg is injected subcutaneously once a week for 48 times.
Other Name: telitacicept


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number changes of gadolinium enhanced T1 lesions in the brain [ Time Frame: At 12, 24, 36, and 48 weeks ]
    Number changes of gadolinium enhanced T1 lesions in the brain at 12, 24, 36, and 48 weeks compared with baseline


Secondary Outcome Measures :
  1. Volume changes of gadolinium enhanced T1 lesions [ Time Frame: At 12, 24, 36 and 48 weeks ]
    Volume changes of gadolinium enhanced T1 lesions at 12, 24, 36 and 48 weeks compared with baseline

  2. Number changes of new low signal T1 lesions [ Time Frame: At week 12, 24, 36, and 48 weeks ]
    Number changes of new low signal T1 lesions at week 12, 24, 36, and 48 weeks compared with baseline

  3. Number changes of new / increased T2 lesions in the brain [ Time Frame: At 12, 24, 36 and 48 weeks ]
    Number changes of new / increased T2 lesions in the brain at 12, 24, 36 and 48 weeks compared with baseline

  4. Volume changes of T2 lesions in brain [ Time Frame: At 12, 24, 36 and 48 weeks ]
    Volume changes of T2 lesions in brain at 12, 24, 36 and 48 weeks compared with baseline

  5. Proportion of patients who did not recur [ Time Frame: Between 0 and 48 weeks ]
    Proportion of patients who did not recur between 0 and 48 weeks

  6. Recurrence rate [ Time Frame: 0-48weeks ]
    Annual recurrence rate


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with relapsing remitting multiple sclerosis meet the diagnostic criteria of McDonald 2017.
  • 18-55 years old, male or female
  • At least 2 recurrences (including clinical recurrence and imaging recurrence) were recorded within 1 year before randomization.
  • Gadolinium enhanced T1 lesions (≥ 1) in the brain at the screening stage
  • EDSS score ≤ 5.5
  • Informed consent signed voluntarily

Exclusion Criteria:

  • Patients with multiple sclerosis over 5 years
  • Those who are unable to perform MRI or who are allergic to gadolinium contrast agent during the test
  • In addition to multiple sclerosis, patients with chronic active immune system disease or stable condition but requiring immunotherapy (glucocorticoids and / or immunosuppressants) (such as rheumatoid arthritis, scleroderma, Sjogren's syndrome, Crohn's disease, ulcerative colitis, etc.) or known immune deficiency syndrome (AIDS, genetic immune deficiency and drug-induced immunity) Patients who used glucocorticoid maintenance therapy before randomization could participate in the trial after discontinuation of the drug
  • Patients with Aquaporin 4 (AQP4) antibody positive and / or Myelin oligodendrocyte glycoprotein(MOG) antibody positive within 1 year before randomization

  • Patients who have received the following treatment:

    1. Interferon, pegylated interferon, galatirel acetate, dimethyl fumarate were used within 4 weeks before randomization.
    2. Fengomod, IV immunoglobulin or plasma exchange within 12 weeks before randomization.
    3. Alemtuzumab, daclizumab and ocrelizumab were used within 24 weeks before randomization.
    4. Before randomization, azathioprine (AZA, half-life t1/2 = 6hrs), mycophenolate mofetil (t1/2 = 16hrs), leflunomide (LEF, t1/2 = 14.7hrs), tacrolimus (t1/2 = 43hrs), teriflunomide (t1/2 = 18 days), cyclosporin, In addition to leflunomide and telifluoramine, immunosuppressants such as CSA, t1/2 = 27 hrs, methotrexate (MTX, t1/2 = 14 HRS), cyclophosphamide (CTX, t1/2 = 6 hrs) can be added to the group after the interval of withdrawal is more than 5 times of half-life. Leflunomide and tertiazem need to be eluted with coleridine. The drug can be stopped and the following measures can be taken: Take 8 g of coleridine three times a day for 11 days. If the dose of 8 g can not be tolerated, it can be changed to 4 g each time. The time and times are the same as before.
    5. Cladribine or mitoxantrone was used within 1 year before randomization.
    6. Lymphoid irradiation and bone marrow transplantation were received 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04625153


Contacts
Layout table for location contacts
Contact: Binghua Xiao 86-010-58076833 Binghua.xiao@remegen.cn

Locations
Layout table for location information
China, Guangdong
the Third Affiliated Hospital,Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China
Contact: Wei Qiu, MD    02085253032    qiuwei120@vip.163.com   
Sponsors and Collaborators
RemeGen Co., Ltd.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: RemeGen Co., Ltd.
ClinicalTrials.gov Identifier: NCT04625153    
Other Study ID Numbers: 18C013
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases