EUCTR2015-004614-26-ES进行中（未招募）1 期
A Randomized, Double-Blind, Multicenter, Equivalence Study of ONS-3010 and Humira® for the Treatment of Patients with Moderate to Severe Plaque Psoriasis
Oncobiologics Limited0 个研究点目标入组 452 人开始时间: 2016年5月24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
- 452
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
- •Patients must meet all of the following inclusion criteria to participate in the study:
- •1. Men or women at least 18 years of age at the time of screening
- •2. Chronic plaque-type psoriasis diagnosed for at least 6 months before
- •randomization and stable for at least 2 months before screening.
- •Patients will be considered to have stable disease if there have been no
- •new lesions while other lesions remain significantly the same, even if the
- •affected surface area is extensive.
- •3. Moderate to severe psoriasis as defined at screening and baseline by
- •meeting all of the following criteria:
- •o PASI score of 12 or greater
- •o sPGA score of 3 or greater (based on a scale of 0 to 5)
- •o BSA affected by plaque-type psoriasis of 10% or greater
- •4. Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the Investigator
- •5. Women of childbearing potential and all males must use an acceptable form of birth control throughout the study. Women of childbearing
- •potential must agree to continue using birth control for 5 months after
- •the last dose. Acceptable methods of birth control include surgery
- •(bilateral tubal ligation, vasectomized partner), hormonal contraceptive (oral, patch, injectable, implantable, intravaginal), intrauterine device, or double physical barrier such as condom plus diaphragm. Postmenopausal status for >1 year will also satisfy this requirement. Also, males are not to donate sperm during the study or for 16 weeks after the last dose.
- •6. Ability and willingness to self-administer study drug
- •7. Ability to read and understand the informed consent form and provide written consent
- •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 298
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 154
排除标准
- •Patients who meet any of the following criteria are ineligible to participate in this study:
- •1. Forms of psoriasis other than chronic plaque-type
- •2. Drug-induced psoriasis
- •3. Ongoing use of prohibited psoriasis treatments. Washout periods prior to baseline (first dose of study drug) for prior psoriasis treatments are as follows:
- •o ?2 weeks for topical medications and ultraviolet B (UVB) phototherapy
- •o ?4 weeks for psoralen plus ultraviolet A (UVA) phototherapy
- •o ?4 weeks for nonbiologic systemic therapies
- •o ?12 weeks for other biologic therapies
- •o ?12 months for alkylating agents
- •4. Exposure to live or live-attenuated vaccines within 8 weeks prior to the screening visit
- •5. Previous exposure to adalimumab
- •6. Treatment with an investigational agent within 12 weeks or 5 half-lives of the drug prior to screening, whichever is longer
- •7. Prior treatment with TNF inhibitors with lack of efficacy as per clinical judgment (primary failure)
- •8. Major surgery within 8 weeks prior to screening or planned to take place during the study period
- •9. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of study treatment
- •10. History of cancer or lymphoproliferative disease (other than successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix)
- •11. History of neurological symptoms suggestive of central nervous system demyelinating disease
- •12. Acute infection requiring treatment with parenteral antibiotics within 4 weeks prior to baseline (first dose of study drug) or oral/topical antibiotics within 2 weeks prior to baseline
- •13. History of human immunodeficiency virus 1 or 2, hepatitis B, or hepatitis C
- •14. Presence of chronic or acute infection at screening, including positive result for active TB or untreated latent TB (eg, positive QuantiFERON® test result without any prior history of active or latent TB, and without evidence of active infection), where the patient is not willing to undergo prophylactic treatment (see Section 11.3)
- •15. History of chronic infection or infections within the past 2 years requiring hospitalization or administration of intravenous antibiotics (without evidence of a cure)
- •16. Known hypersensitivity or history of anaphylactoid reaction(s) to adalimumab or its excipients
- •17. Presence of New York Heart Association (NYHA) Class III/IV heart failure (see Section 11.5)
- •18. History of congestive heart failure, recent cerebrovascular accident, or any other condition that, in the opinion of the Investigator, would put the patient at risk by participation in the study
- •19. History of clinically significant cardiac, respiratory (except for mild asthma), renal, hepatic, hematologic, gastrointestinal, neurologic, or psychiatric disease or disorder, or any other uncontrolled medical illness
- •20. Pregnant, a positive pregnancy test, or intending to become pregnant during
- •during or within 5 months after completion of the study, or breastfeeding
- •21. Impaired bone marrow or hepatic or renal function, including the following:
- •o Hemoglobin <7.14 mmol/L (11.5 g/dL) for males or <6.21 mmol/L (10.0 g/dL) for females, absolute neutrophil count <1.5 x 10^9/L (1500 cells/?L), platelets <100 x 10^9/L (100,000/?L)
- •o Total bilirubin ?1.5 x ULN, excluding cases where elevated bilirubin can be attributed to Gilbert?s syndrome
- •o Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ?1.5 x ULN
- •o Creatinine ?1.5 x ULN
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