Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)

NCT ID: NCT04082416

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 335 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-16
• Study Completion Date: 2022-06-30

Brief Summary

The purpose of this study is to initially access the safety and effectivity of RC18 combined with standard treatment and Placebo combined with standard therapy in subjects with Moderate to severe SLE.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

RC18 160mg

Patients received the test group RC18 160mg weekly administered subcutaneously for 52 times.

Group Type: EXPERIMENTAL

RC18 160 mg plus standard therapy

Intervention Type: BIOLOGICAL

Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator herapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,Tacrolimus ,ciclosporin )

Placebo

Patients received the test group Placebo weekly administered subcutaneously for 52 times.

Group Type: PLACEBO_COMPARATOR

Placebo plus standard therapy

Intervention Type: BIOLOGICAL

Standard therapy comprises any of the following (alone or in combination):

corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,Tacrolimus ,ciclosporin )

Interventions

Placebo plus standard therapy

Standard therapy comprises any of the following (alone or in combination):

corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,Tacrolimus ,ciclosporin )

Intervention Type: BIOLOGICAL

RC18 160 mg plus standard therapy

Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator herapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,Tacrolimus ,ciclosporin )

Intervention Type: BIOLOGICAL

Other Intervention Names

Standard therapy; Standard therapy

Eligibility Criteria

Inclusion Criteria

• Active SLE disease#and at least according with 4 of the 11 items of the American College of Rheumatology (ACR) criteria 1997.
• Age & Gender: Male or female between 18 and 65 years of age inclusive#and the sex ratio is not limited
• Signed informed consent form#willing or able to participate in all required study evaluations and procedures.
• SELENA-SLEDAI(Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index) score ≥ 8 during the screening period.and if there is Hypo-complement or the Anti-dsDNA score, SELENA-SLEDAI disease activity score should be at least 6 at screening .
• Autoantibody-positive
• on a stable SLE treatment regimen for at least 30 days prior to Day 1, which consisted of any of the following (alone or in combination): cortical hormone,anti-malarials,non-steroidal anti inflammatory drugs (NSAIDs),or any immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate

Exclusion Criteria

• kidney disease ：Severe lupus nephritis 8 weeks prior to randomization (designed as:Urine protein>6g/24h or serum creatinine ( SCr>2.5mg/dL or 221umol/L ) or needing for hemodialysis or receipting high dose cortical hormone ≥14 days( metacortandracin>100mg/d or equivalent)
• Central nervous system disease caused by SLE or non SLE 8 weeks prior to randomization (including epilepsy、 mental disease、organic encephalopathy syndrome、cerebrovascular accident, encephalitis, central nervous system vasculitis;
• there are serious heart, liver, kidney and other important organs and blood, endocrine system diseases and medical history;

Evaluation criteria for severity :

1. Alanine aminotransferase#ALT#or aspartate aminotransferase (AST) ≥2 upper limit of normal (ULN);

2. Creatinine Clearance (Ccr)<30ml/min;

3. White Blood Cell Count(WBCs)<2.5x 10(9)/L;

4. hemoglobin<85g/L;

5. Platelets<50x 10(9)/L.

• Have a historically active hepatitis or active hepatitis or medical history,hepatitis B :Patients with positive HBsAg are excluded.;Hepatitis C: Patients with hepatitis C antibody positive are excluded;
• Immune deficiency, uncontrolled severe infection and patients with active or recurrent peptic ulcer;
• Pregnant , lactating women and men or women who have birth plans in the past 12 months ;
• Have a history of allergic reaction to human biological medicines.
• Receipt of live vaccine within 1 month;
• Have participated in any clinical trial in the first 28 days of the initial screening or 5 times half-life period of the study compound (taking the time for the elderly).
• Have received treatment with B cell targeted therapy such as Rituximab or Epratuzumab etc.
• Receipt of anti-tumor necrosis factor#interleukin receptor antagonist#
• Receipt of IV immunoglobulin(IVIG),prednisone>100mg/d more than 14 days or plasma exchange;
• There are active infections (such as herpes zoster, human immunodeficiency virus (HIV) virus infection, active tuberculosis, etc.) during the screening period;
• Patients have depression or the significant suicide ideation;
• Interleukin(IL)-2, thalidomide, Tripterygium wilfordii and traditional Chinese medicine preparation containing Tripterygium Wilfordii were used within 28 days before randomization
• Investigator considers candidates not appropriating for the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RemeGen Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fengchun Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Remegen，ltd.

Yantai, Shandong, China

Countries

China

References

van Vollenhoven RF, Wang L, Merrill JT, Liu Y, Bao C, Li F, Hu J, Huang C, Zhao J, Huang C, Mo H, Wei W, Lu F, Li J, Zhao D, Wang W, Li L, Zuraw Q, Wang X, Wang X, Fang J, Zhang F; 18C010 Trial Investigators. A Phase 3 Trial of Telitacicept for Systemic Lupus Erythematosus. N Engl J Med. 2025 Oct 16;393(15):1475-1485. doi: 10.1056/NEJMoa2414719.

Reference Type: DERIVED

PMID: 41092329 (View on PubMed)

Other Identifiers

18C010

Identifier Type: -

Identifier Source: org_study_id