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临床试验/EUCTR2017-001203-79-DE
EUCTR2017-001203-79-DE进行中（未招募）1 期

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus

Bristol-Myers Squibb International Corporation0 个研究点目标入组 360 人开始时间: 2018年2月27日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
360
研究概览入排标准研究者记录与标识符相似试验

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) Signed Written Informed Consent
  • •2) SLE Disease Characteristics
  • •a) Diagnosed = 24 weeks before the screening visit
  • •b) Meets the SLICC classification criteria for SLE.
  • •c) One of the following: elevated antinuclear antibodies = 1:80 or positive anti-dsDNA( positive includes indeterminate results) or positive anti-Smith as determined by the central laboratory.
  • •d) Total SLEDAI-2K score = 6 points and clinical SLEDAI-2K score = 4 points with joint involvement and/or rash
  • •o Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers cannot count toward the points required for screening at entry.
  • •o Clinical SLEDAI-2K excludes laboratory abnormalities such as hematuria, pyuria, urinary casts, proteinuria, positive anti-dsDNA, decreased complement,
  • •thrombocytopenia, and leukopenia.
  • •e) At least 1 of the following BILAG-based protocol-specific manifestations of SLE:
  • •i) BILAG A or B grade in the Mucocutaneous body system. If a BILAG B grade for
  • •Mucocutaneous disease is due to BILAG #6 mild skin eruption, the total score of the erythema and scale components of the CLASI disease activity must be = 3 (excluding mucous membrane ulcerations and nonscarring alopecia).
  • •ii) Modified BILAG A or B score in the Musculoskeletal body system due to active
  • •polyarthritis.
  • •iii) If only 1 B and no A grade is present in the Mucocutaneous body system or in the Musculoskeletal body system due to arthritis, then at least 1 B grade must be present in one of the other body systems, for a total of 2 BILAG B body system grades.
  • •3) Medications for SLE
  • •a) Background therapy is required for = 12 weeks before the screening visit and must be at a stable dose for = 8 weeks before the screening visit and remain stable until randomization and throughout study participation. Details for specific medications are as follows:
  • •? Immunosuppressants (combinations of these are NOT permitted):
  • •o azathioprine (maximum 200 mg/day)
  • •o 6-mercaptopurine (6-MP)
  • •o methotrexate (MTX; maximum 25 mg/week; dose and route of administration
  • •of MTX may not be changed for 8 weeks before the screening visit and throughout study participation)
  • •o leflunomide
  • •o mycophenolate mofetil/ mycophenolic acid (MMF). Note: Subjects who are
  • •receiving MMF may participate in the study only if administered as a
  • •maintenance therapy and up to a maximum of 2 g/day (or equivalent); in subjects of African ancestry, 3 g/day (or equivalent) is acceptable. Treatment may be interrupted due to neutropenia per the product label.
  • •? Antimalarials: chloroquine, hydroxychloroquine, or quinacrine; monotherapy is permitted.
  • •? Required discontinuation periods for other immunomodulatory drugs or biologic drugs (are provided in Appendix 7 of the protocol.
  • •b) CS (prednisone or equivalent) background therapy is permitted but not required. For subjects taking CS, the dose must be stable for = 2 weeks before the screening visit, cannot exceed 30 mg/day at screening, and must remain stable until randomization. CS monotherapy is not permitted. Prednisone equivalents are provided in Appendix 6. Further specifications are as follows:
  • •? Intramuscular, intra-articular, intrabursal, and intravenous (IV) CS use is prohibited within 6 weeks before screening.
  • •? Topical CS use is permitted, but must follow a stable regimen throughout the study and cannot be used on an as-needed basis.
  • •? Inhaled CS for nonlupus conditions is permitted and will not count against the
  • •maximum CS dose.
  • •? Modified-release CS formulat

排除标准

  • •1) Target Disease Exceptions
  • •a) Drug-induced SLE
  • •b) Other autoimmune diseases are excluded.
  • •c) SLE overlap syndromes such as scleroderma and mixed connective tissue disease are excluded.
  • •d) Subjects with a serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit. Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism and history of pregnancy losses.
  • •e) Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition defined by BILAG A criteria.
  • •f) Active, severe lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS.
  • •2) Other Medical Conditions:
  • •a)Women who are pregnant or breastfeeding
  • •b) Any major illness/condition that will increase the risk with participation in the study
  • •c) Any major surgery within the last 30 days before the first dose of study treatment or planned during the study.
  • •d) Cancer or history of cancer or lymphoproliferative disease within 5 years
  • •e) Class III or IV congestive heart failure
  • •f) Acute coronary syndrome and/or any history of significant cerebrovascular disease within 24 weeks of screening
  • •g) Current or recent (within 3 months pre-randomization) gastrointestinal disease, including surgery, that could impact the absorption of study treatment
  • •h) Subjects with non-SLE concomitant illness that is likely to require additional systemic glucocorticosteroid therapy
  • •i) Significant blood loss or blood transfusion within 4 weeks of randomization
  • •j) Inability to take medication orally
  • •k) Inability to undergo venipuncture and/or tolerate venous access
  • •l) Recent (within 6 months of randomization) drug or alcohol abuse.
  • •3) Prior/Concomitant Therapy
  • •a) Inability to comply with restrictions and prohibited treatments or with discontinuation requirements.
  • •b) Taking more than 1 immunosuppressant.
  • •c) Prior exposure to Tyk2 inhibitors
  • •d) Prior exposure to anifrolumab, rontalizumab or ustekinumab or interferon alpha kinoid
  • •e) Other investigational agents must be discontinued at least 12 weeks or 5 half-lives before randomization, whichever is longer.
  • •4) Findings Related to Possible Infection
  • •a) Evidence of active or latent tuberculosis (TB):
  • •? Positive chest x-ray for evidence of active pulmonary TB within 6 months pre-screening (some exceptions allowed)
  • •? b) Hepatitis C, hepatitis B, or HIV infection as demonstrated by a positive blood screen for hepatitis C antibody (anti-HCV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), or HIV-1 and -2 antibody.
  • •c) Currently on any therapy for chronic infection
  • •d) History of congenital or acquired immunodeficiency
  • •e) Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral antimicrobial agents within 30 days of randomization, or completion of oral antimicrobial agents within 2 weeks of randomization
  • •f) Previous history of herpes zoster, herpes simplex, or influenza infection within 12 weeks of randomization or a history of disseminated/complicated herpes zoster infection
  • •g) Administration of a live vaccine within 90 days or an inactivated vaccine within 30 days of randomization. Furthermore, live vaccines should not be used during treatment or within the 2 months following last dose, and any other inactivated vaccines should be used according to local guidelines.
  • •5) Physical and Laboratory Test Findings
  • •a) Clinically signifi

研究者

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