NL-OMON35833已完成2 期
A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus - Dose repsonse study with sifalimumab in SLE
Astra Zeneca0 个研究点目标入组 12 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects must meet all of the following criteria:
- •1. In the opinion of the investigator, must have adequate reading and writing abilities such that the subject can comprehend and complete the informed consent, and all protocol-related subject assessments.
- •2. Age 18-75 years at the time of screening.
- •3. Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- •4. Fulfils at least 4 of the 11 American College of Rheumatology classification criteria for SLE, one of which must be:
- •a) Significantly positive antinuclear antibody test at screening; OR
- •b) Elevated anti-dsDNA or Sm antibody at screening.
- •5. Weight >= 40.0 kg at screening.
- •6. Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for >= 24 weeks (>= 168 days) prior to screening.
- •7. Currently receiving at least one of the following:
- •a) A stable dose of oral prednisone (or equivalent) <= 20 mg/day from at least 2 weeks (14 days) prior to signing of the informed consent through Day 1.
- •b) Any of the following medications administered at a stable dose for a minimum of 8 weeks (56 days) prior to signing of the informed consent through Day 1: azathioprine, antimalarial (eg. chloroquine, hydroxychloroquine, quinacrine), mycophenolate mofetil/ mycophenolic acid, weekly administrations of oral or sc methotrexate.
- •8. Prior to Day 1, External Adjudication Group confirmation of both:
- •(a) At screening, SLEDAI-2K score >= 6 points or *Clinical* SLEDAI-2K score >= 6 points.
- •(b) At least one of the following: BILAG-2004 Index level A disease in >= 1 body/organ system or 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 >= 1.0 on a 0-3 scale at screening.
- •11. Females of childbearing potential must use 2 effective methods of avoiding pregnancy, have a sterile male partner, are 1 year postmenopausal, or practicing 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 with no documented malignancy (eg. CIN III and AIS) within 24 weeks (168 days) prior to Day 1.
- •14. Willing to abstain from other forms of experimental treatment for SLE during the study.
- •15. Meets all of the following tuberculosis (TB) criteria:
- •a) No history of latent or active TB prior to screening with the exception of latent TB within 3 years prior to screening with documented completion of appropriate treatment.
- •b) No signs or symptoms suggestive of active TB upon medical history or physical examination.
- •c) No recent contact with a person with active TB OR if there has been such contact, referral to a physician specializing in TB to undergo additional evaluation prior to randomization and, if warranted, receipt of appropriate treatment for latent TB at or before the first administration of investigational product.
- •d) Negative diagnostic TB test within 28 days prior to randomization (defined as a negative QuantiFERON-TB Gold for TB at screening) OR a positive diagnostic TB result (defined as a positive QuantiFERON-TB Gold blood assay
排除标准
- •1. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or confound interpretation of subject safety or study results.
- •2. Concurrent enrollment in any other clinical study with an investigational product within 4 weeks (28 days) prior to Day 1 or within 5 half-lives of the investigational product used in that clinical study, whichever is longer.
- •3. Employees of the clinical study site or any other individuals involved with the conduct of the study or immediate family members of such individuals.
- •4. Receipt of any of the following:
- •a) Any new oral prednisone therapy (or equivalent) or any change in current oral prednisone dose (or equivalent) anytime from 2 weeks (14 days) prior to signing of the informed consent through Day 1.
- •b) Any new dose or change in current dose of any of the following anytime in the 8 weeks (56 days) prior to signing of the informed consent through Day 1: azathioprine; any antimalarial (eg. chloroquine, hydroxychloroquine, quinacrine); 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 (56 days) prior to signing of the informed consent.
- •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 informed consent form.
- •8. A known history of allergy or reaction to any component of the investigational product 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) Intra-articular, intramuscular or intravenous glucocorticoids within 6 weeks (42 days) prior to Day 1.
- •b) Any live or attenuated vaccine within 4 weeks (28 days) prior to signing the informed consent form (administration of killed vaccines is acceptable).
- •c) Oral anti-infectives (including antivirals) for active infection within 2 weeks (14 days) prior to Day 1.
- •d) Bacillus of Calmette and Guérin Vaccine (BCG) within 1 year of signing the informed consent form.
- •e) Any restricted medication listed in Appendix 3of the protocol.
- •11. Receipt of any of the following slow-acting immunosuppressants:
- •a) Etanercept <= 4 weeks (<=28 days) prior to signing the informed consent form.
- •b) Adalimumab, infliximab, or golimumab <= 12 weeks (<=84 days) prior to signing the informed consent form.
- •c) Rituximab or belimumab < 24 weeks (<=168 days) prior to signing the informed consent form.
- •12. Any fluctuation in hormone replacement therapy dose within 8 weeks (56 days) of signing the informed consent form.
- •13. Active severe or unstable neuropsychiatric SLE that would make the subject unsuitable for the study or unable to fully understand the informed consent, including but not limited to: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes; acute confusional state; impaired level of c
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