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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 May 2023
• Main ID: NCT04082416
• Date of registration: 01/09/2019
• Prospective Registration: Yes
• Primary sponsor: RemeGen Co., Ltd.
• Public title: Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)
• Scientific title: A Phase III, Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-exploring Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE).
• Date of first enrolment: October 16, 2019
• Target sample size: 335
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04082416
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: Fengchun Zhang, M.D.
• Affiliation: Peking Union Medical College Hospital

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Biological: Placebo plus standard therapy

Biological: RC18 160 mg plus standard therapy

Primary Outcome(s)

SLE Responder Index (SRI) Response Rate [Time Frame: Week 52]

Secondary Outcome(s)

Mean Change From Baseline in Serological Examination Index [Time Frame: week 52]

Percent of subjects with = 4 point reduction from baseline in SELENA-SLEDAI score [Time Frame: Week 52]

Mean Change From Baseline in Physician's global assessment(PGA) [Time Frame: Week 52]

The flare time after randomization [Time Frame: 52 weeks]

Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by = 25% From Baseline or = 7.5 mg/Day,During Weeks 44 Through 52. [Time Frame: Week 44 through 52]

Secondary ID(s)

18C010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors