NL-OMON56483尚未招募不适用
An exploratory, multi-centre, two-part study to describe chronic induced urticaria characteristics and explore novel biomarkers with a multimodal patient profiling approach by comparing CIndU patients to chronic spontaneous urticaria patients and healthy volunteers - Deep phenotyping of CInd
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 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
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Healthy volunteers must meet all of the following inclusion criteria:
- •1. Male and female subjects between 18-69 years of age; in general, stable good
- •health as per judgement of the investigator based upon the results of a medical
- •history, physical examination and vital signs.
- •2. No clinically significant skin disease in the research area
- •3. No history of hypertrophic scarring or keloid.
- •4. Willing to give written informed consent and willing and able to comply with
- •the study protocol.
- •5. Body mass index (BMI) > 18.0 and < 35 kg/m2.
- •6. Negative TempTest and FricTest at screening.
- •7. Participant is willing to refrain from extensively washing (including
- •bathing, swimming, showering and excessive sweating) the skin 12 hours before
- •study visit 1.
- •Eligible patients must meet all of the following inclusion criteria at
- •8. Male and female subjects between 18-69 years old
- •9. Diagnosis of SD, ColdU or CSU (moderate to severe according to international
- •guidelines (Zuberbier et al, 2022)) for >=3 months and symptomatic disease
- •despite treatment with H1 antihistamines (up to fourfold the approved dose).
- •10. Patients currently on an antihistamine (up to fourfold the approved dose)
- •must be on a stable dose for at least 2 weeks prior to day 1 and must maintain
- •the same stable dose throughout the treatment period. Patients are according to
- •the stepped care model
- •eligible to start treatment with omalizumab.
- •11. Body mass index (BMI) > 18.0 and < 35.0 kg/m2.
- •12. Willing to give written informed consent and willing and able to comply
- •with the study protocol.
- •13. Positive provocation test:
- •a) For ColdU patients: developing a wheal at the test site within 10 min after
- •using TempTest® at any temperature at both screening and Baseline;
- •b) For SD patients: developing a wheal at the test site within 10 min after
- •using FricTest® with >= 3mm at both screening and Baseline.
- •14. For CSU patients: negative TempTest® and FricTest® at screening
- •15. Participant is willing to refrain from extensively washing (including
- •bathing, swimming, showering and excessive sweating) the skin 12 hours prior to
- •Day 1 and EOS.
- •16. Female participants of reproductive potential must agree to use
- •contraception from screening until EOS.
排除标准
- •General for all subjects to be enrolled:
- •1. Significant, uncontrolled or unstable disease in any organ system as per
- •judgment of the investigator (regardless of association with the
- •immunosuppressing disorder/therapy), including but not limited to: psychiatric,
- •neurologic, cardiovascular, pulmonary, gastrointestinal, hepatic, renal,
- •endocrine, hematologic or respiratory disease.
- •2. History of immunological abnormality (e.g., immune suppression) that may
- •interfere with study objectives, in the opinion of the investigator.
- •3. Loss or donation of blood over 500 mL within three months prior to
- •4. Positive hepatitis B surface antigen (HbsAg), hepatitis C antibody (HCV ab),
- •or human immunodeficiency virus antibody (HIB ab) at screening (healthy
- •volunteers only)
- •5. Known infection requiring (topical or oral) antibiotic therapy within 56
- •days prior to Day 1.
- •6. The use of systemic antibiotic therapy for >2 months the past 12 months.
- •7. The use of any oral/systemic medication (e.g. immunomodulatory,
- •immunosuppressive) within 28 days prior to Day 1, if the investigator judges
- •that it may interfere with the study objectives.
- •8. Treatment with omalizumab within 5 half lives (120 days) prior to Day 1.
- •9. Pregnant, a positive pregnancy test, intending to become pregnant, or
- •breastfeeding.
- •10. Have any current and/or recurrent clinically significant or subject
- •reported skin condition other than the CInDU/CSU wherefore subject is included
- •in the study.
- •11. Evidence of current drug or alcohol abuse.
- •12. History of regular alcohol consumption within 12 months of the trial
- •defined as an average weekly intake of >21 alcoholic drinks/week for men or >14
- •alcoholic drinks/week for women (i.e., 1 drink is equivalent to 150 mL of wine
- •or 360 mL of beer or 45 mL of hard liquor).
- •Eligible healthy volunteers must not meet the following exclusion criterion at
- •13. Participation in an investigational drug study within 3 months prior to
- •screening or more than 4 times a year.
- •Eligible patients must meet none of the following exclusion criteria at
- •14. For CIndu patients: active CSU or other forms of CIndU besides ColdU or SD
- •that may interfere with study assessments. For CSU patients: presence of active
- •CIndU Disease that may interfere with study assessments.
- •15. Urticarial or angioedema symptoms such as urticarial vasculitis, erythema
- •multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or
- •acquired angioedema (eg, due to C1 inhibitor deficiency).
- •16. Active, pruritic skin condition in addition to CIndU (CIndU patients) or
- •CSU (CSU patients).
- •17. Routine doses of the following medications within 30 days prior to Day 1:
- •Systemic or cutaneous (topical) corticosteroids (prescription or over the
- •counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.
- •18. Intravenous (IV) immunoglobulin G (IVIG), or plasmapheresis within 30 days
- •prior to screening.
- •19. Regular (daily/every other day) doxepin (oral) use within 6 weeks prior to
- •20. Any H2 antihistamine use within 7 days prior to screening.
- •21. Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast)
- •within 7 days prior to Day 1.
- 另有 2 项未显示
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