NL-OMON53201招募中不适用
An exploratory, single-center, two-part study to characterize cutaneous lupus erythematosus and investigate the effect of an immune challenge by comparing CLE patients with healthy volunteers. - Deep phenotyping of cutaneous lupus erythematosus.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Eligible healthy volunteers must meet all the following inclusion criteria at
- •1. Signed informed consent prior to any study-mandated procedure.
- •2. Male or female subjects, 18 years of age or older at the time of signing
- •informed consent; in general, stable good health as per judgement of the
- •investigator based upon the results of a medical history, physical examination,
- •vital signs, ECG, and laboratory assessments performed at screening. Repeated
- •laboratory testing may be performed at the discretion of the clinical
- •investigator.
- •3. Body mass index (BMI) > 18.0 and < 32.0 kg/m2.
- •4. Fitzpatrick skin type I-III (Caucasian).
- •5. Subjects and their partners of childbearing potential must use effective
- •contraception for the
- •duration of the study.
- •6. No clinically significant skin disease as judged by the investigator.
- •7. No history of hypertrophic scarring or keloid.
- •8. Subject is willing to refrain from application of any topical product (e.g.,
- •ointments, cream or washing lotions) on the target lesion(s) 24 hours prior to
- •every study visit day.
- •9. Subject has the ability to communicate well with the investigator in the
- •Dutch language and is willing to comply with the study requirements.
- •Eligible CLE patients must meet all the following inclusion criteria at
- •1. Signed informed consent prior to any study-mandated procedure.
- •2. Male or female CLE patients, 18 years of age or older at the time of signing
- •informed consent; in general, stable good health as per judgement of the
- •investigator based upon the results of a medical history, physical examination,
- •vital signs, ECG, and laboratory assessments performed at screening. Repeated
- •laboratory testing may be performed at the discretion of the clinical
- •investigators.
- •3. Body mass index (BMI) > 18.0 and < 35.0 kg/m2.
- •4. Only applicable for CDLE patients who will also participate in part B:
- •Fitzpatrick skin type I-III (Caucasian).
- •5. Subjects and their partners of childbearing potential must use effective
- •contraception for the
- •duration of the study.
- •6. Patient has the ability to communicate well with the investigator in the
- •Dutch language and is willing to comply with the study requirements.
- •7. Subject is willing to refrain from application of any topical product (e.g.,
- •ointments, cream or washing lotions) on the target lesion(s) 24 hours prior to
- •every study visit day.
- •8. Participants must have a diagnosis of SCLE, CDLE or LET that fulfils the
- •Confirmed CLE diagnosis by clinicopathological correlation.
- •At least one CLE skin lesion of at least 3x3 cm suitable as assessed by the
- •investigator for measurements performed in the study.
- •Location of the lesion(s) selected for biopsy outside the face (possible are
- •e.g., neck, chest, back, limbs, scalp, ear etc.).
- •Receiving one of the following systemic treatments for CLE and SLE (if
- •applicable) (stable for a minimum of 8 weeks) with or without use of local
- •o Hydroxychloroquine
- •o Prednisolone
- •o Methotrexate
- 另有 4 项未显示
排除标准
- •Eligible healthy volunteers must meet none of the following exclusion criteria
- •at screening:
- •1. (History of) immunological abnormality (e.g., immune suppression) that may
- •interfere with study objectives, in the opinion of the investigator.
- •2. Have any current and/or recurrent clinically significant skin condition,
- •including tattoos.
- •3. Antibiotic use, operation, or clinically significatn intervention by
- •surgeon/dentist within one month before Day 1.
- •4. Positive hepatitis B surface antigen (HbsAg), hepatitis C antibody (HCV ab),
- •or human immunodeficiency virus antibody (HIB ab) at screening.
- •5. Participation in an investigational drug study within 3 months prior to
- •screening or more than 4 times a year.
- •6. Loss or donation of blood over 500mL within three months prior to screening.
- •7. Subject is willing to refrain from the use of any medication within 28 days
- •prior to Day 1, if the investigator judges it may interfere with the study
- •objectives.
- •8. History of alcohol abuse or consumption exceeding 5 standard drinks per day
- •on average within 3 months of screening.
- •9. Positive urine test for drugs or history of abuse at screening. Urine drug
- •test may be repeated at the discretion of the investigator.
- •10. Pregnant, a positive pregnancy test, intending to become pregnant during
- •the study conduct, or breastfeeding.
- •11. (A history of) any clinically significant medical condition, factor or
- •abnormality that might interfere with study conduct or interpretation, as
- •judged by the investigator.
- •12. Previous use of Aldara (imiquimod cream) 3 months prior to the Day 1 visit
- •13. Any active or chronic and/or uncontrolled condition that, in the opinion of
- •the investigator, may influence study conduct or interpretation.
- •14. Increased risk of delirium based on the delirium screening (meaning that at
- •least one of the delirium risk questions was answered with *yes* at the
- •screening visit, only applicable for participants > 70 years old).
- •Eligible CLE patients must meet none of the abovementioned and following
- •exclusion criteria at screening:
- •1. Presence of a relevant skin infection or disease in the target areas other
- •than the observational disease (CLE), inclusively, but not limited to atopic
- •dermatitis, psoriasis vulgaris and dermatomycosis.
- •2. Having received treatments for CLE or any other disease within the following
- •intervals prior to Day 1:
- •a. <2 weeks for topical treatment, e.g., corticosteroids at target area(s)
- •b. <6 weeks for systemic therapy with immunosuppressive agents (other than the
- •permitted systemic treatments with stable use for a minimum of 8 weeks)
- •c. <12 weeks for biologics
- •d. <8 weeks procedure or surgery in or close to the target areas
- •e. <3 months for chemotherapeutical treatment
- •3. Presence of severe lupus-associated renal disease.
- •4. Presence of antiphospholipid syndrome.
- •5. Active or unstable lupus-associated neuropsychiatric disease.
- •6. Severe organ SLE manifestation(s) (e.g., active myocarditis) or unstable
- •disease as judged by the investigator.
- •7. Diagnosis of systemic lupus erythematosus (SLE) according to the EULAR-ACR
- 另有 3 项未显示
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