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

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ClinicalTrials.gov Identifier: NCT02885610
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
RemeGen

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, Besides ,to provide dose basis for follow-up clinical trials.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: Placebo plus standard therapy Biological: RC18 80 mg plus standard therapy Biological: RC18 160 mg plus standard therapy Biological: RC18 240 mg plus standard therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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).
Study Start Date : December 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Placebo Comparator: Placebo Comparator
Placebo SC plus standard therapy; placebo once weekly ,and total of 48 doses
Biological: 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,leflunomide, Tacrolimus ,ciclosporin )
Other Name: Standard therapy

Experimental: RC18 80 mg plus standard therapy
RC18 80 mg/kg SC plus standard therapy RC18 80 mg SC once weekly X 48 doses
Biological: RC18 80 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,leflunomide, Tacrolimus ,ciclosporin )
Other Name: Standard therapy

Experimental: RC18 160 mg plus standard therapy
RC18 160 mg/kg SC plus standard therapy RC18 160 mg SC once weekly X 48 doses
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,leflunomide, Tacrolimus ,ciclosporin )
Other Name: Standard therapy

Experimental: RC18 240 mg plus standard therapy
RC18 240 mg/kg SC plus standard therapy RC18 240 mg SC once weekly X 48 doses
Biological: RC18 240 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 therapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin )
Other Name: Standard therapy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Percent of subjects with ≥ 4 point reduction from baseline in SELENA SLEDAI score [ Time Frame: Week 48 ]

Other Outcome Measures:
  1. Mean Change From Baseline in PGA [ Time Frame: Week 48 ]
  2. 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 ]
  3. Mean Change From Baseline in Serological Examination Index(IgG、IgA、IgM) CD19+、Anti-dsDNA 、Complent C3、C4 [ Time Frame: week 48 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885610


Contacts
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Contact: Binghua Xiao 86-010-58076833 xiaosir522@163.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China
Contact: Fengchun Zhang         
Sponsors and Collaborators
RemeGen
Investigators
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Principal Investigator: Fengchun Zhang Peking Union Medical College Hospital

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Responsible Party: RemeGen
ClinicalTrials.gov Identifier: NCT02885610     History of Changes
Other Study ID Numbers: C005 SLECLLI
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents