NL-OMON52891已完成4 期
An exploratory, single-center, double-blinded, healthy volunteer controlled study to characterize psoriasis patients and explore novel biomarkers for the treatment response of psoriasis with a multi-modal patient profiling approach - An explorative psoriasis biomarker study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
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
- •Healthy volunteers
- •Eligible healthy volunteers must meet all of the following inclusion criteria
- •at screening:
- •1. Male or non-pregnant female subjects, 18 to 75 years of age (inclusive);
- •during COVID-19 pandemic this is set to 18 to 69 year of age (inclusive)
- •2. Healthy as defined by the absence of any uncontrolled active or uncontrolled
- •chronic disease following a medical and surgical history, documentation of
- •general symptoms, and a symptom-directed physical examination including vital
- •3. Willing to give written informed consent and willing and able to comply with
- •the study protocol;
- •Psoriasis patients
- •Eligible psoriasis patients must meet all of the following inclusion criteria
- •at screening:
- •1. Male or non-pregnant female subjects, 18 to 75 years of age (inclusive);
- •during COVID-19 pandemic this is set to 18 to 69 year of age (inclusive)
- •2. Diagnosed with plaque psoriasis at least 6 months prior to study
- •participation
- •3. Willing to discontinue any psoriasis therapy other than emollients.
- •4. Having mild ((BSA PASI >=1 and <= 5) (BSA >=1% andPASI <= 5%) or
- •moderate-to-severe (PASI >= 10) plaque psoriasis
- •5. Currently not using psoriasis medication and >= 2 plaques suitable for
- •repeated biopsies and target lesion assessments. At least one of these lesions
- •must be located on the extremities, preferably on the elbow or knee, with a
- •minimal target lesion score between 6 and 9. Or, when currently using psoriasis
- •medication and insufficient lesional skin is present, willing to discontinue
- •treatment awaiting rescreening (see also exclusion criteria 3 for psoriatic
- •6. Willing to give written informed consent and willing and able to comply with
- •the study protocol;
排除标准
- •Healthy volunteers
- •Eligible healthy volunteers must meet none of the following exclusion criteria
- •at screening:
- •1. History or symptoms of any uncontrolled, significant disease including (but
- •not limited to), neurological, psychiatric, endocrine, cardiovascular,
- •respiratory, gastrointestinal, hepatic, or renal disorder that may interfere
- •with the study objectives, in the opinion of the Investigator;
- •2. History of immunological abnormality (e.g., immune suppression, severe
- •allergy or anaphylaxis) that may interfere with study objectives, in the
- •opinion of the Investigator;
- •3. Known infection requiring antibiotic therapy within the last three months
- •prior to the study;
- •4. Immunosuppressive or immunomodulatory treatment within 30 days prior to the
- •5. Body mass index (BMI) <= 18.0 or >= 40.0 kg/m2; during COVID-19 pandemic only
- •<= 18.0 or > 33.0 kg/m2
- •6. Participation in an investigational drug study within 3 months prior to
- •screening or more than 4 times a year;
- •7. Previous participation in an investigational drug study involving the dosing
- •of an investigational compound targeting an immune pathway within one year
- •prior to screening;
- •8. Loss or donation of blood over 500 mL within three months prior to screening;
- •9. The use of any medication or vitamin/mineral/herbal/dietary supplement
- •within less than 5 half-lives prior to study participation, if the Investigator
- •judges that it may interfere with the study objectives. The use of paracetamol
- •(up to 4 g/day) and ibuprofen (up to 1 g/day) is allowed;
- •10. History of alcohol consumption exceeding 5 standard drinks per day on
- •average within 3 months of screening. Alcohol consumption will be prohibited
- •from at least 12 hours preceding each study visit;
- •11. Any other condition that could interfere with the conduct of the study or
- •the study objectives, in the opinion of the Investigator.
- •12. During COVID-19 pandemic: presence of high risk comorbidities: such as
- •cardiovascular, respiratory or immune system disorders
- •Psoriasis patients
- •Eligible psoriasis patients must meet none of the following exclusion criteria
- •at screening:
- •1. Having primarily erythrodermic, pustular or guttate psoriasis;
- •2. Having medication-induced psoriasis;
- •3. Having previously failed on anti-IL23 therapy;
- •4. Having received treatments for psoriasis within the following intervals
- •prior to the start of the study:
- •a. < 2 weeks for topical treatment, e.g. retinoids, corticosteroids, vitamin D
- •b. < 4 weeks for phototherapy, e.g. PUVA, PDT
- •c. < 4 weeks for non-biologic systemic treatment, e.g. retinoids, methotrexate,
- •cyclosporine, fumaric acid esters
- •d. < 4 weeks for etanercept
- •e. < 8 weeks for adalimumab
- •f. < 3 months for anti-IL17, anti-IL12(/23) and anti-IL23 treatments
- •5. History or symptoms of any significant uncontrolled disease including (but
- •not limited to), neurological, psychiatric, endocrine, cardiovascular,
- •respiratory, gastrointestinal, hepatic, or renal disorder that may interfere
- 另有 6 项未显示
研究者
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