EUCTR2018-001238-16-FR进行中（未招募）1 期
A Phase 3b, Randomized, Double-blind, Parallel Group, Multicenter Study to Evaluate Further Therapeutic Strategies with Guselkumab in Patients with Moderate-to-Severe Plaque-Type Psoriasis - GUIDE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 950
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
入选标准
- •1. Male or female with at least 18 years of age.
- •2. Has a disease duration of plaque psoriasis of either =2 years or >2 years calculated from date at which first symptoms [plaque] were reported by subject to date of screening visit at screening; approximately 40% subjects must have a disease duration =2 years.
- •3. Has moderate-to-severe plaque-psoriasis defined by a) a PASI score >10 or affected BSA >10% and b) additionally a DLQI score >10 at baseline (week 0).
- •4. Is a candidate for systemic treatment for psoriasis.
- •5. Before first administration of study drug, a woman must be:
- •a. Not of childbearing potential
- •b. Of childbearing potential and practicing a highly effective method of contraception
- •6. A woman of childbearing potential must have a negative urine pregnancy test at baseline and agree to urine pregnancy testing before receiving injections and at safety follow-up.
- •7. A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 12 weeks after receiving the last administration of guselkumab.
- •8. A male subject must wear a condom when engaging in any activity that allows for passage of ejaculate to another person.
- •9. A male subject must agree not to donate sperm for the purpose of reproduction
- •10. TB-related inclusion criteria:
- •Subjects are considered eligible according to the following TB screening criteria:
- •a. Have no history of latent or active TB before screening.
- •b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
- •c. Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB before the first administration of study drug.
- •d. Within 2 months before baseline, have a negative QuantiFERON®-TB Gold test result, or have a newly identified positive QuantiFERON-TB Gold test result) in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated before baseline.
- •e. Have a chest radiograph (posterior-anterior and lateral views, or per country regulations where applicable), taken within 3 months before the first administration of study drug and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB.
- •11. Agrees not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug.
- •12. Agrees not to receive a BCG vaccination during the study, or within 12 months after the last administration of study drug.
- •13. Clinical laboratory-related inclusion criteria:
- •Has screening laboratory test results within the following parameters, if one or more of the laboratory parameters is out of range, a single retest of laboratory values is permitted:
- •a. Hemoglobin =10 g/dL (SI: =100 g/L)
- •b. White blood cells =3.5 x 103/µL (SI: =3.5 GI/L)
- •c. Neutrophils =1.5 x 103/µL (SI: =1.5 GI/L)
排除标准
- •1 clinically active psoriasis arthritis which needs systemic therapy beyond NSAIDs
- •2 diagnosed or reported history or current signs or symptoms indicating severe, progressive, or uncontrolled hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, which are detected at screening assessments
- •3 unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months, diagnosed or reported by the subject
- •4 transplanted organ
- •5 history of an infected joint prosthesis or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced
- •6 pregnant, nursing, or planning a pregnancy while enrolled in this study and within 16 weeks following the last administration of study drug
- •7 non-plaque form of psoriasis
- •8 current drug-induced psoriasis
- •9 major surgery, within 8 weeks before screening, or will not have fully recovered from surgery at baseline, or has surgery planned during the time the subject is expected to participate in the study
- •10 substance abuse problem within the previous 12 months
- •11 known allergy or sensitivity to products containing latex
- •12 previously received any therapeutic agent directly targeted to IL-23
- •13 received any anti-TNF-a biologic therapy within 3 months before the first administration of study drug
- •14 received any therapeutic agent directly targeted to IL-12/23, IL-17A or IL-17R within 3 months of the first administration of study drug
- •15 received natalizumab, belimumab, or agents that modulate B cells or T cellswithin 12 months of the first administration of study drug
- •16 received any systemic immunosuppressant or anakinra within 4 weeks of the first administration of study drug
- •17 received phototherapy or any systemic medications/treatments that could affect psoriasis or IGA evaluations within 4 weeks of the first administration of study drug
- •18 used topical treatments that could affect psoriasis or IGA evaluations within 2 weeks of the first administration of study drug
- •19 currently receiving lithium, antimalarials, or intramuscular gold, or has received lithium, antimalarials, or IM gold within 4 weeks of the first study drug administration
- •20 received an experimental antibody or biologic therapy within the previous 6 months or received any other experimental therapy or new investigational agent within 30 days or 5 half-lives of first study drug administration or is currently enrolled in another study using an investigational agent or procedure
- •21 received, or is expected to receive, any live virus or bacterial vaccination within 3 months before the first administration of study drug
- •22 had a BCG vaccination within 12 months of screening
- •23 known intolerance or hypersensitivity to any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, mAbs, or antibody fragments
- •24 known allergies, hypersensitivity, or intolerance to guselkumab o
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