CTRI/2024/01/061756招募中2 期
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants with Active Systemic Lupus Erythematosus
BRISTOL MYERS SQUIBB INDIA PRIVATE LIMITED5 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2024年3月16日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 268
- 试验地点
- 5
- 主要终点
- Proportion of participants who achieve an SRI(4)response at Week48
研究概览
简要总结
The data collected during this study are confidential and proprietary to the Sponsor or designee. Any publications or abstracts arising from this study must adhere to the publication requirements set forth in the Clinical Trial Agreement (CTAg) governing [study site or investigator] participation in the study. These requirements include, but are not limited to, submitting proposed publications to the Sponsor or designee at the earliest practicable time prior to submission or presentation and otherwise within the time period set forth in the CTAg. Scientific publications (such as abstracts, congress podium presentations and posters, and manuscripts) of the study results will be a collaborative effort between the study Sponsor and the external authors. No public presentation or publication of any interim results may be made by any principal investigator, sub-investigator, or any other member of the study staff without the prior written consent of the Sponsor. Authorship of publications at BMS is aligned with the criteria of the International Committee of Medical Journal Editors (ICMJE, www.icmje.org). Authorship selection is based upon significant contributions to the study (ie, ICMJE criterion #1). Authors must meet all 4 ICMJE criteria for authorship:
- Substantial intellectual contribution to the conception or design of the work; or the acquisition of data (ie, evaluable participants with quality data), analysis, or interpretation of data for the work (eg, problem solving, advice, evaluation, insights and conclusion); AND
- Drafting the work or revising it critically for important intellectual content; AND
- Final approval of the version to be published; AND
- Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Those who make the most significant contributions, as defined above, will be considered by BMS for authorship of the primary publication. Sub-investigators will generally not be considered for authorship in the primary publication. Geographic representation will also be considered. Authors will be listed by order of significant contributions (highest to lowest), with the exception of the last author. Authors in first and last position have provided the most significant contributions to the work. For secondary analyses and related publications, author list and author order may vary from primary to reflect additional contributions.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed ≥ 12 weeks before the screening visit and qualify as having SLE, according to the SLE International Collaborating Clinics (SLICC) Classification Criteria at the screening visit
- •Test positive for at least 1 of the following lupus-related autoantibodies as determined by the central lab at the time of screening: antinuclear antibody (ANA) ≥ 1:80, anti–double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith (Sm) antibody
- •Total hybrid (h)SLEDAI score ≥ 6 points and clinical hSLEDAI score ≥ 4 points with joint involvement and/or rash (score must be confirmed by the lupus expert review panel [LERP]) i.
- •Alopecia and mucosal ulcers do not count toward the points required for eligibility at screening.
- •Active neuropsychiatric SLE is exclusionary for study participation.
- •Thus, points for seizures, psychosis, organic brain syndrome, visual disturbance, cranial neuropathy, lupus headache, and cerebrovascular accident, as defined by the Hybrid SLEDAI, will also not contribute to scoring ii.
- •Clinical hSLEDAI excludes laboratory abnormalities such as hematuria, pyuria, urinary casts, proteinuria, positive anti-dsDNA, decreased complement, thrombocytopenia, and leukopenia
- •At least 1 of the following BILAG-based protocol-specific manifestations of SLE (must be confirmed by the LERP): i.
- •BILAG-2004 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).
- •Modified BILAG-2004 A or B score in the Musculoskeletal body system due to active polyarthritis (see protocol section 6.1 for criteria)
- •Have a PGA score of disease activity on a 0-3 VAS ≥ 1
- •Be using at least 1 background SLE treatment prior to screening, at a stable dose that must be maintained through study completion.
- •Qualifying background treatments include the following: oral systemic corticosteroids (CS); azathioprine; 6-mercaptopurine (6-MP); methotrexate (MTX); leflunomide; MMF; tacrolimus and antimalarials (e.g., chloroquine, hydroxychloroquine, or quinacrine) ii.
- •Background SLE treatment use is permitted according to specific protocol limits, including maximal dose and minimum duration at stable dose prior to randomization.
- •Daily CS dose may not exceed 20 mg per day of prednisone or equivalent iv.
- •For participants whose only background SLE therapy is CS, the dose should be ≥ 10 mg prednisone or equivalent daily.
- •i) Changes to CS doses are allowed as described in Section 7.7.2.
- •If CS are being used (with or without a non-CS SLE treatment), they must be in use for at least 4 weeks and at a stable dose for at least 2 weeks prior to screening.
- •Background non-CS SLE treatments must be in use for at least 8 weeks and at a stable dose for at least 4 weeks prior to screening.
- •Required discontinuation periods for other immunomodulatory drugs or biologic drugs are provided in APPENDIX 18 of the protocol.
- •If a drug is not specifically listed, consult the medical monitor for guidance.
- •Usual discontinuation periods are 4 weeks or 5 half-lives whichever is longer.
- •Inclusion Criteria for LTE 1) Signed Written Informed Consent i.
- •Participants must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written ICF in accordance with regulatory, local, and institutional guidelines.
- •This must be obtained before the performance of any protocol-related procedures that are not part of normal patient care.
- •Participants must be willing and able to complete all study-specific procedures and visits.
- •Type of Participant and Target Disease Characteristics i.
- •Completion of study treatment through Week
- •In the opinion of the investigator, the participant may benefit from continuation in the optional LTE period.
- •â€¢ Note: If any participant had been given prohibited medications during the placebo-controlled treatment period and was continued in the study, participation of these subjects in the LTE must be discussed with the Medical Monitor.
- •Reproductive Status i.
- •WOCBP must have a negative urine pregnancy test at the initial visit (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadoptropin) 1) If a urine test cannot be confirmed as negative (ie, an ambiguous result), a serum pregnancy test is required.
- •WOCBP must agree to continue using highly effective (with a failure rate of < 1% per year) method(s) of contraception, preferably with low user dependency as described in APPENDIX 4, during the intervention period and for at least 21 days after the last dose of study intervention, and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period 4) Male participants will be required to always use a latex or other synthetic condom during any sexual activity (eg, vaginal, anal, oral) with WOCBP, even if the participants have undergone a successful vasectomy or if their partner is already pregnant or breastfeeding.
- •Males should continue to use a condom during the intervention period and for at least 21 days after the last dose of study intervention.
- •Male participants must refrain from donating sperm during the intervention period and for at least 21 days after the last dose of study intervention.
- •Breastfeeding partners should be advised to consult their health care providers about using appropriate highly effective contraception during the time the participant is required to use condoms.
排除标准
- •Participants with active severe lupus nephritis (LN) as assessed by the investigator.
- •Active or unstable neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI.
- •Additionally, participants with active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition defined by BILAG-2004 A criteria, are excluded, with the exception of participants with mononeuritis multiplex and polyneuropathy, who are allowed.
- •Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE.
- •For example, participants whose prevailing signs and symptoms are consistent with dermatomyositis or systemic sclerosis should be excluded.
- •Alternatively, participants who meet classification criteria for SLE and are treated predominantly as SLE patients, but also have erosive arthritis (i.e., Rhupus), thyroiditis, antiphospholipid syndrome, or polymyositis, should not be systematically excluded.
- •The investigator should consider consultation with the MM to ensure such cases are appropriate for study inclusion.
- •Antiphospholipid Syndrome (APS): i.
- •The following are exclusionary: i) Confirmed diagnosis of APS as defined by the revised Sapporo criteria (see APPENDIX 19) if there has been a thrombotic event or pregnancy morbidity within 12 months before screening ii) History of probable or definite catastrophic APS ii.
- •The following are not exclusionary: i) A positive result for antiphospholipid antibodies at screening is not exclusionary provided there is no history of thrombosis or pregnancy mortality in the past 12 months ii) A thrombotic event more than 12 months before screening is not exclusionary provided the subject is maintained on appropriate anticoagulation therapy (warfarin, low-molecular weight heparin, or newer anticoagulants iii) A history of APS with a history of pregnancy morbidity more than 12 months before screening is not exclusionary provided the subject is maintained on low-dose aspirin or equivalent
- •Inability to comply with restrictions and prohibited treatments, as listed in Section 7.7: Concomitant Therapy.
- •Current daily Oral CS (prednisone or equivalent) ≥ 20 mg QD.
- •Prednisone equivalents are provided.
- •Further specifications are as follows:
- •Intramuscular, intra-articular, intrabursal, and intravenous (IV) CS use is prohibited within 8 weeks before screening.
- •Inhaled and intranasal CS for nonlupus conditions are permitted and will not count toward the maximum CS dose allowed.
- •Modified-release CS formulations are prohibited.
- •Changes in oral CS dose from 2 weeks prior to screening through initial study drug dosing
- •Current or recent use of biologic agent or other prohibited immunosuppressive medication defined
- •Taking more than 1 immunosuppressant, not including CS or antimalarial drugs.
- •Prior exposure to BMS-986256 or another combined TLR7/8 antagonist
- •Use of topical medications/treatments that could affect the appearance of skin lesions within 2 weeks prior to screening
- •Use of strong CYP3A4 inhibitors
- •Recent exposure to other investigational agents; investigational agents must be discontinued at least 4 weeks or 5 half-lives before screening, whichever is longer.
- •Use of any Chinese traditional medicine intended for use in SLE within 4 weeks of randomization
- •Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, psychiatric) or active infection/infectious illness that, as determined by the investigator’s clinical judgment, will substantially increase the risk to the participant if he or she participates in the LTE.
- •For participants who test positive or indeterminate on the IGRA at Week 48, participation in the LTE should be discussed with the Medical Monitor.
结局指标
主要结局
Proportion of participants who achieve an SRI(4)response at Week48
时间窗: Week48
次要结局
- Proportion of participants:(who achieve an SRI(4) response at Week 24Â)
研究者
Shilpi Sinha
Bristol Myers Squibb India Pvt. Ltd.
研究点 (5)
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