- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02885610
Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)
March 2, 2020 updated by: RemeGen Co., Ltd.
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).
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, Besides ,to provide dose basis for follow-up clinical trials.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
249
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Beijing
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Beijing, Beijing, China
- Peking Union Medical College Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 :
- 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).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo Comparator
Placebo SC plus standard therapy; placebo once weekly ,and total of 48 doses
|
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,leflunomide, Tacrolimus ,ciclosporin )
Other Names:
|
EXPERIMENTAL: RC18 80 mg plus standard therapy
RC18 80 mg/kg SC plus standard therapy RC18 80 mg SC once weekly X 48 doses
|
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,leflunomide, Tacrolimus ,ciclosporin )
Other Names:
|
EXPERIMENTAL: RC18 160 mg plus standard therapy
RC18 160 mg/kg SC plus standard therapy RC18 160 mg SC once weekly X 48 doses
|
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,leflunomide, Tacrolimus ,ciclosporin )
Other Names:
|
EXPERIMENTAL: RC18 240 mg plus standard therapy
RC18 240 mg/kg SC plus standard therapy RC18 240 mg SC once weekly X 48 doses
|
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,leflunomide, Tacrolimus ,ciclosporin )
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SLE Responder Index (SRI) Response Rate
Time Frame: Week 48
|
At Week 48, 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 48
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent of subjects with ≥ 4 point reduction from baseline in SELENA SLEDAI score
Time Frame: Week 48
|
Week 48
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean Change From Baseline in PGA
Time Frame: Week 48
|
Week 48
|
Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline or ≤ 7.5 mg/Day During Weeks 44 Through 48
Time Frame: Week 44 through 48
|
Week 44 through 48
|
Mean Change From Baseline in Serological Examination Index(IgG、IgA、IgM) CD19+、Anti-dsDNA 、Complent C3、C4
Time Frame: week 48
|
week 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fengchun Zhang, Peking Union Medical College Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (ACTUAL)
June 11, 2019
Study Completion (ACTUAL)
July 9, 2019
Study Registration Dates
First Submitted
August 26, 2016
First Submitted That Met QC Criteria
August 30, 2016
First Posted (ESTIMATE)
August 31, 2016
Study Record Updates
Last Update Posted (ACTUAL)
March 4, 2020
Last Update Submitted That Met QC Criteria
March 2, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C005 SLECLLI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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