EUCTR2018-003642-17-AT进行中（未招募）1 期
AN EXPLORATORY STUDY TO INVESTIGATE THE BIOAVAILABILITY AND PHARMACODYNAMICS OF DUPILUMAB IN DERMAL INTERSTITIAL FLUID OF ATOPIC DER-MATITIS PATIENTS
Medical University Graz0 个研究点目标入组 8 人开始时间: 2018年9月28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
- 8
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. Male and female atopic dermatitis patients 18 - 65 years of age (both inclusive) at the time of signing informed consent.
- •2. Chronic atopic dermatitis diagnosed for at least 6 months before enrollment (according to American Academy of Dermatology Consensus Criteria [11] and to the UK Working Party's diagnostic criteria for atopic dermatitis [12])
- •3. Moderate-to-severe atopic dermatitis (AD) classified as
- •A) EASI (Eczema Area and Severity Index) [13] score >16 and
- •B) IGA (Investigator’s global Assessment) ([14]) score =3 and
- •C) not adequately controlled by topical medication(s).
- •4. At least one suitable AD lesion that is well accessible for OFM investigation. (A single OFM probe requires a lesion of 35 mm length and 10 mm width; all probes can be placed in one lesion or each OFM probe in an individual lesion.)
- •5. Subject is able to understand the study requirements, procedures, risks and benefits as outlined in the subject information sheet and informed consent form, is willing and able to comply with the specified requirements and procedures, and has signed the in-formed consent form before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suit-ability for the trial.
- •6. If subject is female of child-bearing potential, she must have a negative serum beta human chorionic gonadotropin (ß-HCG) pregnancy test performed within 21 days prior to Visit 2 and use an adequate and acceptable method of birth-control during the study.
- •A female subject is considered of non-childbearing potential if one of the following is reported and documented on the medical history:
- •? postmenopausal with spontaneous amenorrhea for at least one (1) year, or
- •? surgical sterilization
- •7. Subject is available for the entire study duration.
- •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 8
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Pregnant and breast feeding women and women unwilling to use reliable contraception during the study, if of child-bearing potential and sexually active
- •2. Significant allergies to humanized monoclonal antibodies, known hypersensitivity to dupilumab or any of its excipients
- •3. Clinically significant multiple or severe drug allergies, severe drug-induced hypersensi-tivity reactions (including, but not limited to, erythema multiforme major, linear immuno-globulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis); ac-tive dermatoses in need of systemic treatment
- •4. History of an ongoing, chronic or recurrent infectious disease, or known tuberculosis infection (both active and previous) as orally stated by the subject; History of Hepatitis B or C or HIV or positive screening serology test for Hepatitis B, C (acute infection) or HIV
- •5. Alanine transaminase (ALT) >2x upper limit of normal (ULN)
- •6. Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- •7. Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice, or cirrhosis.
- •NOTE: Stable chronic liver disease (including Gilbert’s syndrome, asymptomatic gall-stones) is acceptable if the participant otherwise meets entry criteria
- •8. Asthma treated with other than inhalator medication (i.e. per oral or Intramuscular anti-asthmatic medication is not allowed)
- •9. Known helminth infection; Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assess-ments have ruled out active infection
- •10. Plans for administration of live vaccines during the study period or 4 weeks after last visit or within 12 weeks prior to Visit 2 (dosing).
- •11. Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 16 weeks or 5 half-lives (whichever is longer) or cell-depleting agents within 6 months before baseline, or until lymphocyte count returns to normal (whichever is longer) prior to dosing
- •12. Treatment with dupilumab within 16 weeks prior to dosing
- •13. Immunosuppressive/immunomodulating drugs (systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-?, Janus kinase inhibitors, azathioprine, methotrexate) or phototherapy for AD within 4 weeks before Visit 2, or any condition that in the opinion of the investigator, is likely to require such treatments during the first 4 weeks of study treatment
- •14. Treatment with topical corticosteroids or topical calcineurin inhibitors within 1 week be-fore screening
- •15. Excessive sun exposure: e.g regular use (more than 2 visits per week) of a tanning booth/parlour within 4 weeks prior to first treatment and during the whole study treat-ment period
- •16. Treatment with any other medications for AD that could interfere with efficacy out-comes or affect the evaluation for AD severity
- •17. Uncontrolled systemic disease and ongoing infections (active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to visit 2 or superficial skin infections within 1 week pri-or to the visit 2)
- •18. Known or suspected history of immunosuppression, including history of invasive oppor-tunistic infections (e.g., tuberculosis, histoplasmosis,
研究者
相似试验
已完成
4 期
An exploratory study to investigate the bioavailability andpharmacodynamics of Dupilumab in dermal interstitial fluid od atopic dermatitisatopic dermatitisDRKS00023872Medizinische Universität Graz, Abteilung für Endokrinologie und Diabetologie10
已完成
不适用
A study investigating the biological availability of ALX-0061, a new drug in the treatment of rheumatoid arthritis, after subcutaneous and intravenous administration in healthy volunteers.rheumatoid arthritischronic systemic inflammatory disease10003816NL-OMON40925Ablynx NV70
进行中（未招募）
1 期
Phase I Relative Bioavailability and food effect studyEUCTR2016-002895-29-DEBayer AG
进行中（未招募）
1 期
Phase I relative bioavailability and food effect studyEUCTR2016-002813-24-DEBayer AG
进行中（未招募）
不适用
A Pilot Study to Evaluate the Relative Bioavailability of Diclofenac as Measured by Microdialysis After Repeated Doses of Two Topical Diclofenac Formulations - A Pilot Study to Evaluate the Relative Bioavailability of Two Topical Diclofenac Formulationsot applicable as this study is to compare the extent of absorption of two topical gels.EUCTR2007-005486-34-ATGlaxoSmithKline Consumer Healthcare