2023-503776-25-00招募中4 期
AN INVESTIGATOR-INITIATED, PHASE 4, OPEN-LABEL, SINGLE-ARM, SINGLE-CENTER STUDY INVESTIGATING THE TISSUE-RESIDENT MEMORY T-CELLS AND DISEASE MEMORY IN PSORIASIS SKIN DURING GUSELKUMAB TREATMENT. THE GUSMEM STUDY.
Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年4月28日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in the protein expression using DSP in the microenvironment surrounding TRMs in the epidermis. The following markers in combination will be used to differentiate TRMs: CD3, CD4, CD8, CD103.
研究概览
简要总结
The main aim of the project is to investigate whether guselkumab treatment can change the quantity of TRMs in the skin as well as change the protein expression in the microenvironment around these cells in psoriasis patients.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •History of plaque psoriasis.
- •One target lesion of ~4 cm at its longest axis located on the body (except for the scalp, face, or intertriginous areas), scoring at least 1 for each of redness, thickness, and scaliness on the target plaque severity score (TPSS).
- •Women involved in any sexual intercourse that could lead to pregnancy must agree to use a highly effective contraceptive method from at least 4 weeks before baseline (visit 2). Effective contraceptive methods are: Systemic hormonal contraceptives (oral contraceptive, transdermal patches, vaginal rings, long-acting injectables, or implants), intrauterine devices, vasectomy. This must be used until 12 weeks after EOT. Hormonal contraceptives must be on a stable dose for at least 4 weeks before baseline (visit 2). Women of nonchildbearing potential are as follows: i. Women ≥60 years of age. ii. Women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation) iii. Women >40 and <60 years of age who have had a cessation of menses for at least 12 months and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (FSH ≥40 mIU/mL) or cessation of menses for at least 24 months without FSH levels confirmed. A negative serum pregnancy test at screening and a negative urine pregnancy test at baseline (visit 2) must be presented by women of childbearing potential.
排除标准
- •History or presence of signs or symptom of progressive or uncontrollable infectious, endocrine, neurological, renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, hematological rheumatological, psychiatric or metabolic disturbance and/or abnormal blood test or vital signs other paraclinical information, including disorders of calcium metabolism, that, in the opinion of the investigator, may expose the patient to elevated or unnecessary risk or interfere with the interpretation of results.
- •A history of malignancies within the past five years (excluding localized nonmelanoma skin cancer).
- •Known hypersensitivity to any ingredient in the IMP or to components of the container.
- •Participant has had, or is planning, a major surgery within 8 weeks prior to baseline (except minor minimally invasive procedures).
- •Participant has a contraindication to skin biopsies.
- •Participant is currently receiving an investigational product or device or has received one within 4 weeks prior to baseline, that in the opinion of the investigator, might interfere with the results.
- •Participant has used biologic medication 12 weeks prior to baseline visit (Day 0), or 5 half-lives (whichever is longer).
- •Use of any systemic treatment for psoriasis (such as methotrexate, immunosuppressive drugs, corticosteroids, azathioprine, or cyclosporine) within 4 weeks prior to baseline and during the study.
- •Use of any topical medication to treat psoriasis (including salicylic acid, retinoid, calcineurin inhibitors, corticosteroids, vitamin D analogue, or tar) within 2 weeks prior to baseline. Use of moisturizers and emollients are not exclusion criteria.
- •Participant had psoralen and ultraviolet A or narrowband ultraviolet B treatment within 4 weeks prior to baseline.
- •Female participant who is breastfeeding, pregnant, or who is planning pregnancy during the study period.
- •Participant has a history of an allergic reaction or significant sensitivity to lidocaine or other local anesthetics.
- •History of keloid formation or hypertrophic scarring in suture sites or scars.
- •Known inability or unavailability of a participant to complete required study visits during study participation including any condition associated with poor compliance as judged by the investigator.
- •History of intravenous drug use.
- •A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the participant’s medical history, which, in the opinion of the investigator, may obstruct compliance.
- •Participant protected by the law (adult under guardianship or hospitalized in a public or private institution for a reason other than study, or incarcerated).
- •Mental or linguistic incapacity to sign the consent form.
- •History of concomitant skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments and the acquisition of biopsies.
- •Infectious skin lesions on treated areas (e.g., herpes, varicella, fungal, bacterial, and parasitic skin infections, skin manifestations in relation to tuberculosis).
- •Treated skin must not be affected by perioral dermatitis, striae atrophicae, atrophic skin, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, and wounds.
- •Active or latent tuberculosis requiring treatment.
- •History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the subject taking antiretroviral medications as determined by medical history and/or subject’s verbal report.
- •No history of varicella zoster infection and negative varicella antibody test (until varicella vaccination is completed), positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (anti-HCV) serology at screening.
- •Other psoriasis subtype that according to investigator may influence any assessments (erythrodermic, guttate, pustular, inverse, drug-induced).
结局指标
主要结局
Change in the protein expression using DSP in the microenvironment surrounding TRMs in the epidermis. The following markers in combination will be used to differentiate TRMs: CD3, CD4, CD8, CD103.
Change in the protein expression using DSP in the microenvironment surrounding TRMs in the epidermis. The following markers in combination will be used to differentiate TRMs: CD3, CD4, CD8, CD103.
Change in the number of TRMs in the epidermis and dermis between baseline and EOT using IHC. The following markers in combination will be used to differentiate cells: CD3, CD4, CD8, CD103.
Change in the number of TRMs in the epidermis and dermis between baseline and EOT using IHC. The following markers in combination will be used to differentiate cells: CD3, CD4, CD8, CD103.
次要结局
- Change in CD11c+ Dendritic cells over the study duration.
- Change in CD163+ Macrophages over the study duration.
- Change in Langerin+/CD207+ Langerhans-cells over the study duration.
- Change in Myeloperoxidase+ Neutrophils over the study duration.
- Change in CD4+/FOXP3+ single and double positive cells over the study duration.
- Change in CD103/RORγt single and double positive cells over the study duration.
- Change in CD3+, CD4+, CD8+, CD49a+, CD69+, and CD103+ multiple, or single positive cells over the study duration.
- Change in proliferation assessed using Ki67+ staining over the study duration.
- Change in epidermal thickness over the study duration.
研究者
Christian Vestergaard
Scientific
Aarhus University Hospital
研究点 (1)
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