JPRN-jRCT2051220123进行中（未招募）3 期
A Multicenter, Randomized, Double-Blind, Parallel-Arm, Phase 3 Study to Compare Efficacy and Safety of BAT2306 with Cosentyx in Patients with Moderate to Severe Plaque Psoriasis
Yoo EunHye0 个研究点目标入组 60 人开始时间: 2022年11月29日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Each patient must meet all of the following criteria to be enrolled in this study:
- •1. Male or female >= 18 years old with a diagnosis of plaque-type psoriasis for at least 24 weeks before screening.
- •2. Have moderate to severe plaque-type psoriasis as defined at screening and baseline by:
- •a. PASI >= 12,
- •b. IGA >= 3 (based on a scale of 0-4), and
- •c. BSA affected by chronic plaque-type psoriasis >= 10%
- •3. Candidates for systemic therapy, defined as having chronic plaque-type psoriasis considered inadequately controlled by:
- •a. topical treatment and/or
- •b. phototherapy and/or
- •c. previous systemic therapy.
- •4. Female patients of childbearing potential and male patients with a female partner of childbearing potential must be willing to use a highly effective contraceptive precaution throughout the study period and continuing for at least 20 weeks after the last dose of study drug. Abstinence from heterosexual intercourse is accepted when this is the usual lifestyle of the patient and must be continued for at least 20 weeks after the last dose of study drug. A female patient is considered not of childbearing potential when postmenopausal (at least 12 consecutive months without menses without an alternative medical cause) or surgically sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
- •5. If female of childbearing potential, patient should have a negative pregnancy test result at screening and baseline visits.
- •6. Must be willing to provide written consent and to comply with the requirements of the study protocol.
排除标准
- •Patients meeting any of the following criteria will be excluded from the study:
- •1. Have any forms of psoriasis at the time of the screening visit other than plaque-type such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medicationinduced psoriasis or other skin conditions (e.g. eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.
- •2. Have previously received secukinumab, a biosimilar of secukinumab, or any drug that targets interleukin-17 or the IL-17 receptor (e.g. ixekizumab, brodalumab).
- •3. Weight > 120 kg.
- •4. Have received any monoclonal antibody-based biologic drugs for treatment of PsO or PsA or with a potential effect on the study condition other than those prohibited (see exclusion #2) within 5 half-lives or 6 months, whichever is longer, before baseline visit.
- •5. Have received non-monoclonal antibody biological drugs (e.g. etanercept) for the treatment of PSO or PSA within 12 weeks or 5 half-lives (whichever is longer) before baseline visit.
- •6. Have received topical therapies for the treatment of psoriasis (such as but not limited to corticosteroids, vitamin D analogs, retinoids, herbal or non-pharmacological topical preparations other than moisturizers or emollients) within 2 weeks before baseline visit.
- •7. Have received phototherapy such as ultraviolet (UV) A phototherapy (with or without oral psoralen), UVB phototherapy, or any systemic steroids, or nonbiological drugs for treatment of PsO or PsA or with a potential effect on the study condition (such as but not limited to methotrexate, apremilast, acitretin, tofacitinib, upadacitinib, sulfasalazine, or cyclosporine) within 4 weeks before baseline visit.
- •8. Have received any investigational drug within 8 weeks or 5 half-lives (whichever is longer) before the screening visit.
- •9. Have received any herbal remedies or traditional medicines for systemic use used to treat psoriasis within 4 weeks before baseline visit.
- •10. Have current or chronic inflammatory or autoimmune disease other than plaque psoriasis that may affect patients' safety or study assessment. Patients with concurrent psoriatic arthritis will be allowed to participate.
- •11. History of allergy to the active substance or any of the excipients of study drugs, or of hypersensitivity to latex.
- •12. Plan to receive any live vaccination after screening and during the study period (Patient must agree not to receive a live vaccination during the study), or with any Covid-19 vaccination within 2 weeks prior to baseline visit.
- •13. Have clinical signs or symptoms consistent with COVID-19 infection, e.g. fever, dry cough, dyspnea, sore throat, fatigue, or confirmed infection by appropriate laboratory test within the last 4 weeks before Screening or during Screening. Resolution of confirmed infection is defined as a negative appropriate COVID-19 laboratory test or at least 4 weeks since recovery from symptoms in those symptomatic or at least 4 weeks without any symptom after a positive COVID-19 test in those asymptomatic.
- •14. History of invasive infection (e.g. histoplasmosis, coccidioidomycosis, blastomycosis).
- •15. Presence of active infection at screening, history of infection requiring intravenous antibiotics and/or hospitalization <= 8 weeks before baseline visit or oral antibiotics <=2 weeks before baseline visit. Minor fungal infections may be allowed.
- •16. Any recurrent bacterial, fungal, or viral infection that, (based on the investigator's clinical asses
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