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

  • STATUS
    Recruiting
  • End date
    Nov 21, 2022
  • participants needed
    18
  • sponsor
    RemeGen Co., Ltd.
Updated on 21 March 2022

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.

Details
Condition Multiple Sclerosis, Relapsing-Remitting
Treatment RC18 160mg, RC18 240mg
Clinical Study IdentifierNCT04625153
SponsorRemeGen Co., Ltd.
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with relapsing remitting multiple sclerosis meet the diagnostic criteria of McDonald 2017
-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
Interferon, pegylated interferon, galatirel acetate, dimethyl fumarate were used within 4 weeks before randomization
Fengomod, IV immunoglobulin or plasma exchange within 12 weeks before randomization
Alemtuzumab, daclizumab and ocrelizumab were used within 24 weeks before randomization
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
Cladribine or mitoxantrone was used within 1 year before randomization
Lymphoid irradiation and bone marrow transplantation were received before randomization
Patients were participated in any clinical trial 28 days before randomization or
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
within 5 times half-life of study drug participating in clinical trial
(whichever is longer)
Cancer patients
Pregnant women, lactating women and patients with family planning during the trial
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
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
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