EUCTR2010-018948-14-DK进行中（未招募）1 期
A Dose-Ranging And Efficacy Study of LY2439821 (an Anti-IL-17 Antibody) in Patients With Moderate-To-Severe Psoriasis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 125
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
- •Inclusion Criteria Common to Both Part A and B:
- •[1] Ambulatory male or female patients =18 years of age.
- •[1a] Male patients:
- •agree to use a reliable method of birth control during the study.
- •[1b] Female patients:
- •Women of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a highly reliable method of birth control as defined by those which result in a low failure rate (<1% per year) during the study.
- •Women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
- •Post menopausal female patients defined as women >45 years of age who have had a cessation of menses for at least 12 months OR are women between 40 and 45 years of age who test negative for pregnancy, have had a cessation of menses for at least 12 months, and have a Follicle Stimulating Hormone (FSH) value >40 mIU/mL.
- •[2] Present with chronic plaque psoriasis based on a diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization; at least 10% BSA involvement; and a PASI score of at least 12 at Visits 1 and 2
- •[30] Are a candidate for systemic therapy.
- •[31] Have a sPGA score of at least 3 at Visits 1 and 2.
- •Inclusion Criterion Specific to Part B:
- •[32] Patients who have completed the treatment period for Part A. A patient is defined as having completed the treatment period for Part A if he/she has completed at least through Week 20.
- •Inclusion Criterion Specific to Part C
- •[35] Patients who have completed the treatment period for Part B.
- •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 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •3. Have pustular, erythrodermic and/or guttate forms of psoriasis.
- •4. Have had a clinically-significant flare of psoriasis during the 12 weeks prior to randomization.
- •5. Have received systemic psoriasis therapy (such as psoralen and ultraviolet A [PUVA] light therapy, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, azathioprine) or phototherapy (including ultraviolet B or self-treatment with tanning beds or therapeutic sunbathing) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
- •6. Concurrent or recent use of any biologic agent within the following washout periods: etanercept <28 days, infliximab or adalimumab <56 days, alefacept <60 days, ustekinumab <8 months, or any other biologic agent <5 half-lives prior to baseline.
- •7. Current or expected use of concomitant medications or treatments other than those listed in Section 9.8, unless approved by the sponsor.
- •8. Are currently enrolled in, or have discontinued within the last 30 days (prior to Visit 1) from a clinical trial involving use of an investigational drug or device, or are currently enrolled in any other type of medical research not compatible with this study.
- •9. Have previously completed or withdrawn from this study.
- •10. Have had a live vaccination within 12 weeks before randomization, or intend to have a live vaccination during the course of the study, or have participated in a vaccine clinical trial within 12 weeks prior to randomization.
- •11. Have evidence of active infection, such as fever =38.0oC within 5 days of dosing.
- •12. Have evidence of or test positive for hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV) antibodies.
- •13. Are immunocompromised, have had a recent or current serious systemic or local infection (including infectious mononucleosis-like illness or herpes zoster), or have evidence of active or latent tuberculosis
- •14. Have thyroid-stimulating hormone (TSH) outside of the laboratory’s reference range.
- •15. Have a history of uncompensated heart failure, fluid overload, myocardial infarction, or evidence of ischemic heart disease or other serious cardiac disease within 12 weeks before randomization.
- •16. Have a history of chronic liver disease, peripheral vascular disease or cerebrovascular disease, or epilepsy.
- •17. Have current serious or unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease and other conditions that, could interfere with study conduct.
- •18 Have uncontrolled arterial hypertension characterized by a repeated systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg.
- •19 Have current or a history of lymphoproliferative disease; or signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or active primary or recurrent malignant disease; or been in remission from clinically significant malignancy for less than 5 years.
- •20 Have a history of atopy or significant allergies to humanized monoclonal antibodies, or clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions
- •21 Have laboratory test values outside the reference range for the population or investigative site that are considered clini
研究者
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