RC18 in Patients With Relapsing Remitting Multiple Sclerosis：a Phase II Trial
Study Details
Study Description
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 |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| 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 Names:
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| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Number changes of gadolinium enhanced T1 lesions in the brain [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
- Volume changes of gadolinium enhanced T1 lesions [At 12, 24, 36 and 48 weeks]
Volume changes of gadolinium enhanced T1 lesions at 12, 24, 36 and 48 weeks compared with baseline
- Number changes of new low signal T1 lesions [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
- Number changes of new / increased T2 lesions in the brain [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
- Volume changes of T2 lesions in brain [At 12, 24, 36 and 48 weeks]
Volume changes of T2 lesions in brain at 12, 24, 36 and 48 weeks compared with baseline
- Proportion of patients who did not recur [Between 0 and 48 weeks]
Proportion of patients who did not recur between 0 and 48 weeks
- Recurrence rate [0-48weeks]
Annual recurrence rate
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with relapsing remitting multiple sclerosis meet the diagnostic criteria of McDonald 2017.
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18-55 years old, male or female
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At least 2 recurrences (including clinical recurrence and imaging recurrence) were recorded within 1 year before randomization.
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Gadolinium enhanced T1 lesions (≥ 1) in the brain at the screening stage
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EDSS score ≤ 5.5
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Informed consent signed voluntarily
Exclusion Criteria:
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Patients with multiple sclerosis over 5 years
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Those who are unable to perform MRI or who are allergic to gadolinium contrast agent during the test
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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
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Patients with Aquaporin 4 (AQP4) antibody positive and / or Myelin oligodendrocyte glycoprotein(MOG) antibody positive within 1 year before randomization
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Patients who have received the following treatment:
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Interferon, pegylated interferon, galatirel acetate, dimethyl fumarate were used within 4 weeks before randomization.
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Fengomod, IV immunoglobulin or plasma exchange within 12 weeks before randomization.
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Alemtuzumab, daclizumab and ocrelizumab were used within 24 weeks before randomization.
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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.
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Cladribine or mitoxantrone was used within 1 year before randomization.
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Lymphoid irradiation and bone marrow transplantation were received before randomization.
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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).
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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.
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The results of abnormal laboratory tests to be excluded include but are not limited to: Leukocyte count < 3 × 109 / L; neutrophil < 1.5 × 109 / 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;
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Cancer patients
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Pregnant women, lactating women and patients with family planning during the trial
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Patients with other mental disorders
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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
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The researchers believe that the patients are compliant insufficiently or not suitable to participate in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the Third Affiliated Hospital,Sun Yat-Sen University | Guangzhou | Guangdong | China |
Sponsors and Collaborators
- RemeGen Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18C013