EUCTR2010-024069-30-ES进行中（未招募）不适用
A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 544
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Able to comprehend and complete the informed consent, and all protocol-related subject assessments.
- •2) Age 18-75 years.
- •3) Written informed consent.
- •4) Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE, one of which must be: a) Significantly positive antinuclear antibody (ANA) test at screening by immunofluorescent assay (IFA) at central lab; OR b) Elevated anti-dsDNA or Sm antibody at screening as determined by central lab
- •5) Weight = 40.0 kg.
- •6) Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for = 24 weeks prior to screening.
- •7) Receiving at least one of the following (at stable doses) prior to signing ICF through Day 1: a) prednisone (or equivalent) = 20 mg/day for at least 2 weeks; b) one of the following for at least 8 weeks: azathioprine, an antimalarial, mycophenolate mofetil/ mycophenolic acid, weekly administrations of oral or SC methotrexate.
- •8) External Adjudication Group confirmation of both: a) SLEDAI-2K score = 6 points or ‘Clinical’ SLEDAI-2K score = 6 points; b) At least one of the following: i) BILAG-2004 Index level A disease in = 1 body/organ system ii) BILAG-2004 Index level B disease in = 2 body/organ systems.
- •9) Day 1 ‘Clinical’ SLEDAI-2K score = screening Clinical” SLEDAI-2K score.
- •10) Physicians Global assessment (MDGA) = 1.0 on a 0-3 scale at screening.
- •11) Females of childbearing potential must use 2 effective methods of avoiding pregnancy from screening through 180 days after the final dose of investigational product unless surgically sterile, has a sterile male partner, is 1 year postmenopausal, or practices abstinence.
- •12) Non-sterilized males must practice two effective contraceptive measures with a female of childbearing potential from Day 1 through at least 180 days after the last dose of investigational product has been administered.
- •13) Females with an intact cervix must have documentation of a Pap smear and HPV
- •testing with no documented malignancy within 24 weeks prior to Day 1.
- •14) Willing to forego other forms of experimental treatment for SLE during the study.
- •15) Meets various criteria for freedom from tuberculosis.
- •16) Adequate peripheral venous access.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 517
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 27
排除标准
- •1) Any condition that would interfere with evaluation of the IMP or interpretation of subject safety or study results.
- •2) Concurrent enrollment in any other study with an IMP within 4 weeks prior to Day 1 or within 5 half-lives of the IMP used in that study, whichever is longer.
- •3) Employees of the study site or any other individuals involved with the study or immediate family members.
- •4) Receipt of any of: a) any new oral prednisone therapy (or equivalent) or any change in current oral prednisone dose (or equivalent) from 2 weeks prior to signing of the ICF through Day 1; b) any new dose or change in current dose of any of the following anytime in the 8 weeks prior to signing of the ICF through Day 1: azathioprine; any antimalarial; mycophenolate mofetil/mycophenolic acid; oral methotrexate; or SC methotrexate.
- •5) Receipt of any of the following: a) azathioprine > 150 mg/day; b) mycophenolate mofetil/mycophenolic acid > 3.0 grams/day; c) oral or SC methotrexate > 20 mg/week; d) any change in route of administration of oral or SC methotrexate anytime within the 8 weeks prior to signing of the ICF.
- •6) Receipt of more than one dose of sifalimumab prior to screening.
- •7) Receipt of a biologic agent within 5 half-lives or prior to loss of PD and/or clinical effect, whichever is longer, prior to signing of the ICF.
- •8) A known history of allergy or reaction to any component of the IMP formulation or history of anaphylaxis to any human gamma globulin therapy.
- •9) Receipt of more than one prescribed NSAID at an anti-inflammatory dose within 2 weeks (14 days) prior to Day 1; OR receipt of fluctuating doses of a prescribed NSAID within 2 weeks (14 days) prior to Day 1;.
- •10) Receipt of any of the following: a) any live vaccine within 4 weeks prior to signing the ICF; b) oral anti-infectives (including antivirals) for active infection within 2 weeks prior to Day 1; c) BCG vaccine within 1 year of signing the ICF; d) any restricted medication (as listed in Appendix 3 of the protocol).
- •11) Receipt of any of the following: a) etanercept = 4 weeks prior to signing the ICF; b) adalimumab, infliximab, or golimumab = 12 weeks prior to signing the ICF; c) rituximab or certolizumab pegol < 24 weeks prior to signing the ICF.
- •12) Any fluctuation in hormone replacement therapy dose within 8 weeks of signing the ICF.
- •13) Active severe or unstable neuropsychiatric SLE that would make the subject unsuitable for the study or unable to fully understand the ICF.
- •14) Within 8 weeks prior to screening, active severe SLE-driven renal disease or unstable renal disease.
- •15) A diagnosis (within 1 year) of mixed connective tissue disease or any history of overlap syndromes of SLE with rheumatoid arthritis, erosive arthritis, or scleroderma.
- •16) History of, or current, inflammatory joint or skin disease other than SLE that could interfere with the inflammatory arthritis or skin assessments and confound the disease activity assessments.
- •17) History of asthma that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to randomization.
- •18) Known history of a primary immunodeficiency or an underlying condition such as HIV infection or splenectomy that predisposes to infection.
- •19) Confirmed positive tests for hepatitis B surface antigen serology.
- •20) Positive test for hepatitis C serology as confirmed by central laboratory.
- •21) Any serious herpes infection at any time prior to randomiza
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