EUCTR2014-005258-20-DE进行中（未招募）1 期
A 24-week, randomized, controlled, multicenter, open-label study with blinded assessment of the efficacy of subcutaneous secukinumab compared to Fumaderm® in adults with moderate to severe plaque psoriasis - PRIME
ovartis Pharma GmbH0 个研究点目标入组 200 人开始时间: 2015年2月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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
- 性别
- All
入选标准
- •1. Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator, and must give a written, signed and dated informed consent before any study related activity is performed.
- •2. Men or women must be at least 18 years of age at the time of screening
- •3. Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization
- •4. Patients with moderate to severe plaque psoriasis who are candidates for systemic therapy as defined at randomization by:
- •- PASI score of >10
- •- Affected body surface area (BSA) > 10%
- •- DLQI >10
- •5. Patients for whom topical psoriasis treatment alone is no longer sufficient. Inadequate response, intolerance or contraindication to topical psoriasis treatment must have been documented in the patient’s medical history or reported by the patient or determined by the investigator at screening.
- •6. Patients for whom Fumaderm® is expected to be the patient-individually optimized standard therapy under consideration of Fumaderm®, Ciclosporin, Methotrexate or phototherapy (Balneophototherapy, oral PUVA, NB-UVB) as per investigator’s discretion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Forms of psoriasis other than plaque psoriasis
- •2. Drug-induced psoriasis
- •3. Previous exposure to biologic drugs directly targeting IL-17A or IL-17RA, or prior treatmt. with Fumaderm® or other fumaric acid derivatives
- •4. Previous systemic treatmt. of plaque psoriasis or known contraindication for systemic therapy at baseline
- •5. Ongoing use of other prohibited psoriasis + non-psoriasis treatmt. Washout periods detailed in the prot. have to be adhered to. All other previous non-psoriasis concomitant treatmt. must be on a stable dose at least 4 wks. before randomization
- •6. Plans for admin. of live vaccines during the study period
- •7. Use of any other investigational drugs within 4 wks. of study drug initiation or within a period of 5 half-lives of the investigational treatmt., whichever is longer
- •8. Known hypersensitivity to secukinumab and/or other components of secukinumab, i.e. sucrose, L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, L-methionine
- •9. Pats. with latex hypersensitivity
- •10. Known hypersensitivity to fumaric acid derivatives, or other components of Fumaderm® INITIAL/Fumaderm®
- •11. Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations incl. but not limited to recurrent respiratory and/or urinary tract infections or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold test at screening. Subjects with a positive or indeterminate QuantiFERON TB-Gold may participate in the study if further full tuberculosis work up completed at least 12 wks. prior to randomization establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatmt. must have been initiated + maintained according to local country guidelines for at least 4 wks. prior to randomization
- •12. Past medical history record of,or current infection with, HIV, hepatitis B or hepatitis C prior to randomization
- •13. Pats. with Crohn´s disease
- •14. Pats. with severe liver diseases
- •15. Pats. with severe gastrointestinal diseases incl. but not limited to ventricular + duodenal ulcers
- •16. Pats. with severe kidney diseases or serum creatinine above 1 x ULN. Pats. with serum creatinine above 1 x ULN may be incl. if the lab. abnormality is deemed clinically irrelevant by the investig.
- •17. Pats. with known hematological disease or with any of the following hematology lab results >1xULN or <1x LLN at screening: erythrocyte count, leukocyte count, lymphocyte count, monocytes, neutrophils, basophils, eosinophils, platelets, hemoglobin. Pats. with hematology lab results >1x ULN or<1x LLN may be included if the lab. abnormality is deemed clinically irrelevant by the investig.
- •a. who are pregnant or breast feeding (pregnancy defined as the state of a female after conception + until the termination of gestation, confirmed by a positive hCG lab. test. Pats. with a positive hCG lab. test may participate in the study if they are postmenopausal or if further work up by a qualified physician establishes conclusively that the pat. is not pregnant + does not suffer from malignancy or any other condition that would constitute an excl. criterion.
- •b. who are menstruating + capable of becoming pregnant + not practicing a medically approved method of contraception (Pearl Index <1) during + up to at least 16 wks. after the end of treatmt. A neg. pregnancy test (serum) for all women is required
研究者
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