PER-037-23尚未招募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)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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
- 性别
- All
入选标准
- •Individual participants 18 to 75 years of age.
- •Must have been diagnosed with SLE at least 24 weeks prior to screening.
- •Meet the European Alliance of Associations for Rheumatology/American College of Rheumatology 2019 classification criteria for SLE at screening.
- •Test positive for at least 1 of the following lupus-related autoantibodies at the time of screening: antinuclear antibody (ANA) = 1:80, anti-dsDNA antibody, or anti-Smith antibody (anti-Sm), as determined by the central laboratory.
- •Have a total SLEDAI-2K score = 6 points, and clinical SLEDAI-2K score = 4 points and must include joint involvement, and/or cutaneous vasculitis, and/or rash (SLEDAI score will undergo review by the RRG).
- •oLupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI-2K, if indicated, but do not count toward the points required for screening at entry.
- •oClinical SLEDAI-2K excludes laboratory abnormalities such as hematuria, pyuria, urinary casts, proteinuria, positive anti-dsDNA, decreased complement, thrombocytopenia, and leukopenia.
- •Inclusion Criteria for the Optional Long-term Extension Period Only
- •1) Signed Written Informed Consent: Must be willing to participate in the LTE period and must be willing and able to sign the informed consent form (ICF).
- •2) Type of Participants and Target Disease Characteristics Completion of the protocol-required double-blind treatment period and receiving blinded study drug. Note: If a participant is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational [medicinal] product [IP/IMP] due to COVID-19 pandemic), the participant may be allowed to enroll with approval from the Medical Monitor.
排除标准
- •Medical conditions
- •oConditions that may complicate SLE diagnosis or assessment of disease activity.
- •oLife- or organ-threatening SLE manifestations
- •Medical conditions and history
- •oMedical conditions that may place participant at higher risk for taking an investigational therapy.
- •Prior and concomitant therapy
- •oExposure to prohibited immunomodulatory drugs or biologic drugs.
- •oTaking more than 1 immunosuppressant at screening.
- •oOral corticosteroids (prednisone or equivalent) = 30 mg per day.
- •oPrior exposure to TYK2 inhibitors.
- •Infection and/or immune-related exclusions
- •oInfections or immune-related conditions that may place participant at higher risk when taking an immunomodulating agent.
- •Physical and laboratory test findings
- •oClinically significant abnormalities on chest x-ray or ECG.
- •oClinically significant abnormalities in laboratory tests, including the following:
- •?Serum alanine aminotransferase (ALT) > 2× ULN, unless confirmed due to SLE activity and confirmed not due to any other etiology.
- •Exclusion Criteria for the Optional Long-term Extension Period Only
- •1) Medical History and Concurrent Diseases
- •a) Any disease or medical condition that, in the opinion of the investigator, would make the participant unsuitable for this study, would interfere with the interpretation of participant’s safety or study results, or considered unsuitable by the investigator for any other reason.
- •2) Findings Related to Possible TB Infection
- •a) Evidence of active TB, as judged by the investigator, or evidence of LTBI (as indicated by positive IGRA or indeterminate IGRA in the absence of guidance from local expert stating
- •treatment is not necessary) in participant unwilling to undergo prophylactic treatment (see Section 9.4.4: Tuberculosis Screening and Chest X-ray).
- •Note: All participants will undergo complete physical examination and medical history to evaluate exposure to TB, and all participants will complete TB questionnaire annually. If
- •participants are at increased risk based on TB questionnaire, they must undergo IGRA with further assessment/treatment outlined in Section 9.4.4: Tuberculosis Screening and Chest X-ray. All participants with positive or indeterminate IGRA should be discussed with the Medical Monitor.
研究者
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