CTRI/2024/11/076583招募中3 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (SLE)(POETYK SLE-1)
Bristol Myers Squibb India Private Limited7 个研究点 分布在 1 个国家目标入组 490 人开始时间: 2024年11月20日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 490
- 试验地点
- 7
- 主要终点
- Proportion of participants who achieve SRI4 response at Week52 Reduction from Baseline of greatar than or equal to 4points in the
研究概览
简要总结
This Phase3 study is designed to evaluate the efficacy and safety of 3 mg deucravacitinib BID versus placebo in an active moderate to severe SLE population
Study Duration Approximately 60weeks for participants who do not enroll into the optional LTE period and approximately 164weeks for participants who enroll into the optional LTE period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Diagnosed with SLE at least 24weeks before the screening visit b) Meet the European Alliance of Associations for Rheumatology or American College of Rheumatology 2019 classification criteria for SLE c) One of the following as determined by the central laboratory at screening positive antinuclear antibodies which is greater or equal than ration 1 is to 80 OR positive anti dsDNA OR positive anti-Smith antibody anti Sm d) Total SLEDAI 2K score is equal or greater than 6 points and clinical SLEDAI 2K score is equal to or greater than 4 points with joint involvement and or cutaneous vasculitis and or rash and must be confirmed by RRG e) At least 1 BILAG A or 2 BILAG B grades must be present at screening including at least 1 of the following BILAG based protocol specific manifestations of mucocutaneous or musculoskeletal SLE must be confirmed by RRG i) BILAGA or B grade in the mucocutaneous body system.If a BILAGB grade for mucocutaneous disease is due to BILAG 6 mild skin eruption the total score of the erythema and scale components of the Cutaneous Lupus Erythematosus Disease Area and Severity Index CLASI disease activity must be greater than or equal to 3 excluding mucous membrane ulcerations and nonscarring alopecia ii) Modified BILAG A or B score in the musculoskeletal body system due to active polyarthritis defined as follows (1) BILAG A severe arthritis BILAG 41 manifested by observed active synovitis in is greater than or equal to 6 joints (a) Hips shoulders neck low back and temporomandibular joint may not count toward the total number of joints with active synovitis for the purposes of study entry (b)There must be marked loss of functional range of movements and significant impairment of basic activities of daily living ADL This is defined as follows (i)Requiring the assistance of another person or an assistive device in ambulation toileting and grooming including bathing dressing and feeding oneself At least 1 must be present and documented in source 1) Not responsive to therapy such as CS prednisone or equivalent greater than or equal to 10mg per day participants who are intolerant of or otherwise unable to take CS should be discussed with RRG or the Medical Monitor 2) Impairment from arthritis must have been present on several days that is greater than 4days cumulatively over the past 4weeks and must be present at the time of the screening visit (2) BILAG B moderate arthritis or tendonitis or tenosynovitis BILAG 42 defined as tendonitis or tenosynovitis or active synovitis in greater than or equal to 3joints observed through history (a) Hips shoulders neck low back and temporomandibular joint may not count toward the total number of joints with active synovitis for the purposes of study entry (b) There must be some loss of functional range of movements due to arthritis as manifested by difficulty in performing any one of the instrumental ADL such as cooking driving using the telephone or computer shopping cleaning etc that has been present on several days ie greater than 4days over the last 4weeks and is present at the time of the screening visit 3) If there is no A grade present in the mucocutaneous body system or in the musculoskeletal body system and if there is only 1 B grade present in the mucocutaneous or musculoskeletal body system per specifications above then there must be at least 1 B grade in another body system for a total of 2 BILAG B body system grades f) At least one of the following SLE background therapies immunosuppressant and or antimalarial is required for is greater than or equal to 12weeks before the screening visit must be at a stable dose for greater than or equal to8weeks before the screening visit and must remain stable until the Week 52 visit i)Immunosuppressants participants can only be on ONE immunosuppressant (1) azathioprine maximum 200mg per day (2) 6 mercaptopurine 6 MP maximum 200mg per day (3) methotrexate MTX maximum 25 mg per week dose and route of administration of MTX may not be changed for 8weeks before the screening visit and throughout study participation (4) leflunomide maximum20mg per day (5) tacrolimus maximum 0.2mg per kg per day (6) mizoribine maximum 150mg per day (7) mycophenolate mofetil MMF mycophenolic acid MPA Note: Participants who are receiving MMF as a maintenance therapy up to a maximum of 2000 mg per day or equivalent MPA dose 1440 mg per day may participate in the study If a participant requires higher doses up to 3000 mg per day MMF or equivalent MPA dose 2160 mg per day and is tolerating it without toxicity please discuss with the RRG or Medical Monitor Treatment may be interrupted due to neutropenia per the product label Note If a listed immunosuppressant above requires wash out and is not included in Appendix 7 the time period for washout shall be 2 weeks or5 half lives prior to screening whichever is longer i) Antimalarials chloroquine hydroxychloroquine or quinacrine monotherapy use is permitted Dosing shall be commensurate with regional guidance and investigator judgment Participants can only be on ONE antimalarial but can be on both an immunosuppressant and an antimalarial It is recommended that participants receiving antimalarials undergo screening for retinal toxicity in accordance with local guidelines Note Should a listed antimalarial above require washout the time period for washout shall be 2 weeks prior to Screening g) OCS prednisone or equivalent background therapy is permitted but not required For participants taking OCS the dose must be stable for greater than or equal to 2weeks before the screening visit cannot exceed 30mg per day at screening and must remain stable until the Week4 visit Participants can be on an OCS as well as an antimalarial and or an immunosuppressant Further specifications are as follows • Topical CS low to moderate potency is permitted but a stable regimen must be followed and cannot be used on an as needed basis • Inhaled CS for non-lupus conditions is permitted and will not count against the maximum CS dose h) Oral and or topical non steroidal anti inflammatory drugs NSAIDs including aspirin or cyclooxygenase 2 inhibitors are allowed as a stable therapy or on an as needed basis provided they are taken within the dose and frequency ranges on their respective labels Participants on NSAIDs must agree to follow restrictions around study visits i) Opioid analgesics are allowed provided the doses administered do not exceed 30 mg of morphine per day or equivalent Participants on opioids must agree to follow restrictions around study visits j) All participants must undergo eligibility review and receive confirmation of eligibility by the RRG prior to randomization.
排除标准
- •Medical Conditions a) Diagnosis of drug induced SLE rather than idiopathic SLE instances in which prior diagnosis of drug induced SLE was later determined to be unrelated to medication must be discussed with the RRG b)Other autoimmune diseases eg multiple sclerosis psoriasis inflammatory bowel disease etc are excluded Participants with type I autoimmune diabetes mellitus thyroid autoimmune disease Celiac disease or secondary Sjogrenss syndrome are not excluded c)SLE overlap syndromes including but not limited to rheumatoid arthritis scleroderma and mixed connective tissue disease are excluded d)Concomitant fibromyalgia chronic fatigue syndrome or chronic pain syndrome if the symptoms or therapy are likely to significantly impact the assessment or interpretation of SLE disease manifestations and activity based on discussion with eligibility reviewers e)Any of the following, which could potentially increase the risk of thrombosis i)Confirmed diagnosis of APS as defined by the Sapporo criteria refer to Appendix5 (1) if there has been a thrombotic event or pregnancy morbidity within 12 months before screening (2) if there has been a thrombotic event or pregnancy morbidity more than 12months before screening and participant is not maintained on appropriate therapy ii) History of catastrophic antiphospholipid syndrome CAPS iii) Participants with no diagnosis of antiphospholipid syndrome APS and with a positive result for antiphospholipid antibodies at screening plus history of thrombosis or pregnancy morbidity must be reviewed by EEAC for possible increased risk for thrombosis which could be exclusionary f) Active or unstable lupus neuropsychiatric manifestations including but not limited to any condition defined by BILAG A criteria g) Active severe Class III and IV lupus nephritis that requires or may require treatment with cytotoxic agents or high dose CS are excluded Participants with prior controlled renal disease with serum creatinine less than or equal to 2× upper limit of normal ULN and either residual proteinuria up to 3 g per day or a urine protein is to creatinine ratio UPCR of 3 mg per mg or 339mg per mmol are allowed Stability of renal disease must be documented with at least 2measurements of proteinuria or UPCR over the past 6 months.
结局指标
主要结局
Proportion of participants who achieve SRI4 response at Week52 Reduction from Baseline of greatar than or equal to 4points in the
时间窗: week 52
Systemic Lupus Erythematosus Disease Activity Index 2000 SLEDAI 2K score and No new BILAG A or not more than 1 new
时间窗: week 52
BILAGB organ domain scores and No worsening in PGA less than 0.3point increase
时间窗: week 52
from baseline using a visual analog scale VAS with anchor scores ranging from 0 to 3
时间窗: week 52
次要结局
- Proportion of participants who achieve BICLA response at Week52(Proportion of participants who achieve both SRI 4 and BICLA dual responders at Week52)
- Change from baseline in patient reported fatigue(according to FACIT Fatigue at Week52)
研究者
Shilpi Sinha
not applicable
研究点 (7)
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