EUCTR2018-002918-12-NL进行中（未招募）1 期
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Apremilast (CC-10004) in Pediatric Subjects from 6 through 17 Years of Age with Moderate to Severe Plaque Psoriasis - SPROUT
Amgen Inc.0 个研究点目标入组 230 人开始时间: 2019年1月15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
- 230
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
- •Subject must satisfy the following criteria to be enrolled in the study:
- •1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informed consent form is signed by the legal guardian
- •2. Subjects must have a weight of = 20 kg
- •3. Subject must have age and sex-specific BMI value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart for children and adolescents.
- •4. Subject is able to swallow the study medication tablet
- •5. Able to sign an age-appropriate assent with a legal guardian(s) who understand(s) and voluntarily sign(s) an informed consent prior to any study-related assessments/procedures being conducted.
- •6. Be willing and able to adhere to the study visit schedule and other protocol requirements.
- •7. Diagnosis of chronic plaque psoriasis for at least 6 months prior to screening.
- •8. Has moderate to severe plaque psoriasis at screening and baseline as defined by:
- •PASI score = 12; and
- •Body surface area (BSA) = 10%; and
- •sPGA = 3 (moderate to severe)
- •9. Disease inadequately controlled by or inappropriate for topical therapy for psoriasis.
- •10. Candidate for systemic therapy or phototherapy.
- •11. At screening, laboratory values must be within the following ranges
- •White blood cell (WBC) count
- •Age (years) Males (x 103 /µL) Females (x 103 /µL)
- •6-11 3.5 – 13.5 3.5 – 13.5
- •12-18 3.5 – 13.5 3.5 – 13.5
- •Platelet count
- •Age (years) Males (x 103 /µL) Females (x 103 /µL)
- •6-11 125 – 500 125 – 500
- •12-18 125 – 500 125 – 500
- •Serum creatinine = 1.2 x upper-limit of normal (ULN) for age and gender. Please see reference ranges of the central laboratory
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) = 1.5 x ULN for age and gender. If initial test of ALT or AST is > 1.5 x ULN, one repeat test is allowed during Screening. Please see the reference ranges of the central laboratory
- •Total bilirubin = 2 mg/dL (= 34 µmol/L). If initial test result is > 2 mg/dL, one repeat test is allowed during the Screening period
- •Hemoglobin (Hb)
- •Age (years) Males (g/dL) Females (g/dL)
- •6-11 10.0 – 15.0 10.0 – 15.0
- •12-18 11.0 – 16.5 10.5 – 15.5
- •12. All females of childbearing potential (FCBP) must either practice abstinence* from heterosexual contact or use one of the approved contraceptive options as described below while on apremilast and
- •during any dose interruption, and for at least 28 days after administration of the last dose of apremilast. For the purpose of thisstudy, a female subject is considered of childbearing potential if she is = 12 years old or has reached menarche, whichever occurred first.
- •At the time of study entry, and at any time during the study when a female subject of childbearing potential's contraceptive measures or ability to become pregnant changes, the Investigator will educate the subject regarding abstinence or contraception options and the correct and consistent use of effective contraceptive methods in order to successfully prevent pregnancy.
- •Females of childbearing potential must have a negative pregnancy test at Screening and Baseline. All FCBP who engage in activity in which conception is possible must use one of the approved contraceptive+ options described below:
- •Option 1: Any one of the following highly effective methods: hormonal contraception
排除标准
- •The presence of any of the following will exclude a subject from
- •enrollment:
- •1. Other than psoriasis, history of any clinically significant (as
- •determined by the Investigator) cardiac, endocrinologic, pulmonary,
- •neurologic, psychiatric, hepatic, renal, hematologic, immunologic
- •disease, or other major uncontrolled disease.
- •2. Any condition, including the presence of laboratory abnormalities,
- •or psychiatric illness, that would place the subject at unacceptable risk
- •if he/she were to participate in the study
- •3. Any condition that confounds the ability to interpret data from the
- •4. Evidence of skin conditions, other than psoriasis, that would
- •interfere with clinical assessments
- •5. Pregnant or breastfeeding
- •6. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline
- •7. Psoriasis flare or rebound within 4 weeks prior to Screening
- •8. Positive Hepatitis B surface antigen, or anti-hepatitis C antibody, at Screening
- •9. History of positive human immunodeficiency virus infection (HIV),
- •congenital and acquired immunodeficiencies (eg, common variable
- •immunodeficiency, immunoglobulin A deficiency)
- •10. Active tuberculosis (TB) or a history of incompletely treated TB
- •11. History of recurrent significant infections
- •12. Active infection or infection treated with antibiotic treatment within 2 weeks of first dose
- •13. Any history of or active malignancy
- •14. History of allergy/intolerance to any component of the
- •investigational product, ie, apremilast, lactose monohydrate,
- •microcrystalline cellulose, croscarmellose sodium, magnesium stearate,
- •hypromellose 15cP, titanium dioxide, polydextrose food chemical color,
- •talc, maltodextrine, medium chain triglycerides, iron oxide red, iron
- •oxide yellow, and iron oxide black.
- •15. Deficiencies in lactose metabolism, ie, galactose-1-phosphate
- •uridylyltransferase, UDP-galactose 4-epimerase, galactokinase or
- •Fanconi Bickel syndrome, including congenital lactase deficiencies, and
- •glucose-galactose malabsorption.
- •16. Prior history of suicide attempt at any time in the subject's
- •lifetime prior to Screening or randomization in the study, or major
- •psychiatric illness requiring hospitalization within 3 years prior to
- •signing the assent and informed consent
- •17. Answer Yes to any question on the Columbia-Suicide Severity
- •Rating Scale during Screening or at Baseline
- •18. Current or planned concurrent use of the following therapies that
- •may have a possible effect on psoriasis
- •a. Topical therapy within 2 weeks prior to randomization (including
- •but not limited to topical corticosteroids, topical retinoid or vitamin D
- •analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol)
- •Exceptions*:
- •i. Low potency or weak corticosteroids (please refer to the
- •Investigators' Manual) will be allowed as background therapy for
- •treatment of the face, axillae and groin in accordance with
- •manufacturer's suggested usage
- •ii. Unmedicated skin moisturizer (eg, Eucerin®) will also be permitted
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