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

NCT04082416 | Completed Phase 3 DMC

• 1 other identifier: 18C010
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• SLE Responder Index (SRI) Response Rate

  At Week 52 the percent of subjects with ≥ 4 point reduction from baseline in SELENA-SLEDAI score and increasing no more than 0.3 points in PGA and no new BILAG A organ domain score or 1 new BILAG B organ domain scores compared with baseline at the time of assessment

  Week 52

Secondary Outcomes (5)

• Percent of subjects with ≥ 4 point reduction from baseline in SELENA-SLEDAI score

  Week 52

• Mean Change From Baseline in Physician's global assessment(PGA)

  Week 52

• Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline or ≤ 7.5 mg/Day，During Weeks 44 Through 52.

  Week 44 through 52

• Mean Change From Baseline in Serological Examination Index

  week 52

• The flare time after randomization

  52 weeks

Study Arms (2)

RC18 160mg

EXPERIMENTAL

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

Biological: RC18 160 mg plus standard therapy

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo plus standard therapy

Interventions

Placebo plus standard therapy 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 )

Also known as: Standard therapy

Placebo

RC18 160 mg plus standard therapy 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 )

Also known as: Standard therapy

RC18 160mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 :
• Alanine aminotransferase#ALT#or aspartate aminotransferase (AST) ≥2 upper limit of normal (ULN);
• Creatinine Clearance (Ccr)\<30ml/min;
• White Blood Cell Count(WBCs)\<2.5x 10(9)/L;
• hemoglobin\<85g/L;
• 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).

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Remegen，ltd.

Yantai, Shandong, China

Location

Related Publications (1)

• 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.

  PMID: 41092329 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Standard of Care; RC-18

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Fengchun Zhang, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2019
• First Posted: September 9, 2019
• Study Start: October 16, 2019
• Primary Completion: April 24, 2022
• Study Completion: June 30, 2022
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

CN (1)