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

• ClinicalTrials.gov Identifier: NCT04625153
• Recruitment Status: Recruiting
• First Posted: November 12, 2020
• Last Update Posted: January 11, 2022
• Sponsor: RemeGen Co., Ltd.
• Information provided by (Responsible Party): RemeGen Co., Ltd.

Tracking Information

• First Submitted Date: November 6, 2020
• First Posted Date: November 12, 2020
• Last Update Posted Date: January 11, 2022
• Actual Study Start Date: June 2, 2021
• Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 6, 2020)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 6, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: RC18 in Patients With Relapsing Remitting Multiple Sclerosis：a Phase II Trial
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Multiple Sclerosis, Relapsing-Remitting

Intervention

• Biological: RC18 160mg
  RC18 160mg is injected subcutaneously once a week for 48 times.
  Other Name: telitacicept
• Biological: RC18 240mg
  RC18 240mg is injected subcutaneously once a week for 48 times.
  Other Name: telitacicept

Study Arms

• Experimental: RC18 160mg
  RC18 160mg is injected subcutaneously once a week for 48 times.
  Intervention: Biological: RC18 160mg
• Experimental: RC18 240mg
  RC18 240mg is injected subcutaneously once a week for 48 times.
  Intervention: Biological: RC18 240mg

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 6, 2020): 18
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2022
• Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Binghua Xiao; 86-010-58076833; Binghua.xiao@remegen.cn

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04625153
• Other Study ID Numbers: 18C013
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: RemeGen Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: RemeGen Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: RemeGen Co., Ltd.
• Verification Date: January 2022