A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune system
- Conditions
- Systemic Lupus ErythematosusMedDRA version: 14.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2010-024069-30-IT
- Lead Sponsor
- ASTRAZENECA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 544
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 antidsDNA 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 90 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 90 days after the last dose of investigational product has been administered. 13) Females with an intact cervix must have documentation of a Pap smear 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
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 belimumab < 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. for other, refer to CSP
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method