Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02885610
• Date of registration: 26/08/2016
• Prospective Registration: No
• Primary sponsor: RemeGen
• Public title: Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)
• Scientific title: A Phase IIb , Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-explorating 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: December 2015
• Target sample size: 249
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02885610
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Fengchun Zhang
• 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
hypocomlement 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
,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin ).

Exclusion Criteria:

- Severe lupus nephritis within two months(designed as:Urine protein>6g/24h or serum
creatinine ( SCr)>2.5mg/dL or 221umol/L ) or needing for hemodialysis or recepting
high dose cortical hormone =14 days( metacortandracin>100mg/d or equivalent)

- Central nervous system disease caused by SLE or non SLE within two months (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;

- 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: RC18 80 mg plus standard therapy

Biological: Placebo plus standard therapy

Biological: RC18 160 mg plus standard therapy

Biological: RC18 240 mg plus standard therapy

Primary Outcome(s)

SLE Responder Index (SRI) Response Rate [Time Frame: Week 48]

Secondary Outcome(s)

Percent of subjects with = 4 point reduction from baseline in SELENA SLEDAI score [Time Frame: Week 48]

Secondary ID(s)

C005 SLECLLI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors