ACTRN12606000040561已完成2 期
A single centre, double blind, parallel group, three arm, Phase IIa clinical trial designed to assess the efficacy and safety of Cpn10 administered as twice weekly intravenous injections in subjects with plaque psoriasis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CBio Limited
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Have been diagnosed with plaque psoriasis for at least 6 months. 2. Have plaque psoriasis covering > 10 % body surface area (BSA). 3. Have a PASI score of > 12 at the screening visit. 4. Have a Physician’s Global Assessment (PGA) Score of at least ‘moderate’ at the screening visit. 5. Have psoriasis that is not controlled by current therapies. 6. Weigh less than 120 kg. 7. Sexually active women of child bearing potential must agree to use a medically reliable method of preventing conception for the duration of the study, unless surgically sterile or post menopausal. Sexually active men whose partners are of childbearing potential must agree to use a medically reliable method of preventing conception for the duration of the study, unless surgically sterile. 8. Be willing to hold sun exposure reasonably constant and to avoid use of tanning booths during the study. Narrowband UVB (NBUVB) treatment for psoriasis is permitted prior to and during the course of this study. 9. Have provided written informed consent to participate in the trial.
排除标准
- •1. Have guttate, erythrodermic or pustular psoriasis as the sole or predominant form of psoriasis.2. History of allergic or anaphylactic reactions to Cpn10.3. Have a clinically significant psoriasis flare during screening or at the time of enrolment.4. Have a history of or ongoing bacterial, viral, fungal or atypical mycobacterial infection.5. Have a history of opportunistic infections (e.g. systemic fungal infections, parasites) within the preceding 6 months.6. Have a seropositive test to HIV, Hepatitis B or Hepatitis C at screening.7. Female who is lactating or pregnant (confirmed by a positive serum ?-HCG pregnancy test at screening).8. Subjects with the following laboratory test results at screening:(a) White blood cell (WBC) count <4000/L(b) Aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase levels greater than 3 times the upper limit of normal range for the laboratory conducting the test.(c) Serum creatinine > 2 times the upper limit of normal range for the laboratory conducting the test.9. Have a history of active tuberculosis confirmed by a chest X-ray and Quantiferon TB gold testing at screening10. Have been diagnosed with a malignancy or have a history of malignancy within the last 5 years. Subjects with fully excised basal or squamous cell carcinomas may be enrolled.11. Have a diagnosis of hepatic cirrhosis, regardless of the cause or severity.12. Have been admitted to hospital for cardiac disease, stroke or pulmonary disease within the last 12 months13. Have a history of substance abuse within the last 5 years.14. Have a medical condition that in the opinion of the investigator would jeopardise the subject’s safety following exposure to the study drug.15. Have received treatment with the following medications:(a) Immunosuppressive drugs within 28 days prior to study day 0.(b) Prior treatment with the following anti-TNF-alpha agents: infliximab, etanercept or adalumumab(c) Live or killed virus or bacteria vaccines within 14 days of study day 0(d) Other vaccines or allergy desensitisation therapies within 14 days of study day 0(e) Other experimental drugs or treatments within 28 days or 5 half-lives (whichever is longer) prior to study day 0(f) Beta-blockers, ACE inhibitors, interferons, quinidine, antimalarial drugs or lithium. If clinically indicated these medications are allowed but the dosage must be held constant from screening and throughout the trial period.16. Deemed by the investigator to be uncooperative or unsuitable for inclusion into this trial.
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