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

NCT04625153 | Terminated Phase 2 DMC

• 1 other identifier: 18C013
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (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

  0- 48 weeks

Secondary Outcomes (7)

• 24 weeks confirmed disability progression

  0-24weeks

• 12 weeks confirmed disability progression

  0-12weeks

• 12 weeks confirmed disability improvement

  0-12weeks

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

  At 12, 24, 36 and 48 weeks

• Number of new low-signaling T1 lesions in the brain

  At 12, 24, 36 and 48 weeks

Study Arms (2)

RC18 160mg

EXPERIMENTAL

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

Biological: RC18 160mg

RC18 240mg

EXPERIMENTAL

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

Biological: RC18 240mg

Interventions

RC18 160mg BIOLOGICAL

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

Also known as: telitacicept

RC18 160mg

RC18 240mg BIOLOGICAL

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

Also known as: telitacicept

RC18 240mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with relapsing remitting multiple sclerosis meet the diagnostic criteria of McDonald 2017.
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

the Third Affiliated Hospital,Sun Yat-Sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

RC-18; telitacicept

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 12, 2020
• Study Start: May 13, 2021
• Primary Completion: April 3, 2026
• Study Completion: April 3, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CN (1)