2023-504298-19-00招募中2 期
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety deucravacitinib in patients with chronic hand eczema
Charite Universitaetsmedizin Berlin KöR4 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2023年11月9日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 57
- 试验地点
- 4
- 主要终点
- Therapeutic efficacy of deucravacitinib defined as the percentage of patients achieving a clinical response (Investigator Global Assessment 0 or 1) with ≥ 2-point improvement in IGA for patients with chronic hand eczema at week 16
研究概览
简要总结
To evaluate the efficacy of daily application of 6 mg BID deucravacitinib compared with a placebo in the treatment of adult subjects with chronic hand eczema.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients must have signed and dated an IRB/IEC-approved written informed consent form in accordance with regulatory and institutional guidelines before the performance of any protocol-related procedures
- •Patients with diagnosis of chronic hand eczema (persisted > 3 months or returned twice or more within the past 12 months)
- •Patients with moderate to severe disease and Investigator Global Assessment (IGA) score ≥ 3 (scale of 0 to 4) at screening and baseline visit.
- •Patients with failed topical therapy for 6 weeks will be included and patients should be eligible for a systemic therapy
- •Male or female patients aged 18 to 65 years old
- •Patients with BMI (body mass index) of ca. 18-35 kg/m2
- •Patients able to provide written informed consent
- •Patient willing and able to comply with clinic visits and study related procedures
排除标准
- •Diagnosis of any concurrent skin disease on the hands, e.g. tinea manuum
- •Patients who have any of the following specific abnormalities on screening laboratory tests: a) hemoglobin <10.0 g/dL (100.0 g/L), b) total white blood cell count <2500 cells/µL, c) neutropelymphonia (absolute neutrophil count [ANC] <1000 cells/µL), d) penia (lymphocyte count <750 cells/µL), e) thrombocytopenia (platelets <100,000/µL), f) alkaline phosphatase >3x upper limit of normal (ULN) or alkaline phosphatase >2,5x ULN and total bilirubin > 2x ULN, g) aspartate transaminase (AST, SGOT) and alanine transaminase (ALT, SGPT) > 2.5x upper limit of normal (ULN)
- •Treatment with any of the following agents: Janus kinase inhibitors, immunosuppres-sive/immunomodulating drugs including but not limited to methotrexate, azathioprine, dapsone, leflunomide, mycophenolate-mofetil; retinoids (e.g. alitretinoin); cyclospor-ine; sulphasalasine, hy-droxychloroquine sulphate, TNF-alpha inhibitors (etaner-cept, adalimumab, alefacept), colchicine, and IFN-γ within 1 month prior to screening.
- •Active AD requiring medical treatment in regions other than the hands
- •Diagnosis of tuberculosis (TB) with a positive QuantiFER-ON-TB Gold Plus test or high TB risk after assessment of recent close or prolonged contact with someone with in-fectios TB disease (defined as within the last 12 months) and/or recent travel to or from a high burden country of TB (as listed by the WHO, https://www.who.int/news/item/17-06-2021-who-releases-new-global-lists-of-high-burden-countries-for-tb-hiv-associated-tb-and-drug-resistant-tb)
- •Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline
- •Use of a live vaccine 90 days prior to screening, or during this study
- •Patients, who are older than 50 years and do not have a vaccination against Herpes zoster
- •Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit
- •Subject is currently enrolled in another investigational device or drug trial(s), has re-ceived investigational drug within 90 days before baseline visit
- •Pregnant or breastfeeding women or planning to become pregnant or breastfeed during the patient’s participation in this study
- •Evidence of chronic kidney disease with an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation) or if subject is receiving dialysis
- •Women of childbearing potential (WOCBP) who are unwilling to practice highly effec-tive contraception prior to the initial dose/start of the first treatment, during the study, and for at least 30 days after the last dose.
- •Potential subjects who are in a dependent/employment relationship with the sponsor, investigator or clinical trial site.
- •Active psoriasis or severe acneiforme skin disease on any part of the body
- •Potential subjects who are placed in an institution due to a court or official order
- •Presence of skin comorbidities that may interfere with the study assessments
- •Clinically significant infection (e.g. impetiginised hand eczema) on the hands
- •Severe concomitant illness(es) that, in the investigator’s judgment, would adversely af-fect the patient’s participation in the study. Patients with uncontrolled diabetes (HbA1c ≥ 9%), patients with cardiovascular conditions including stage III or IV cardiac failure according to the New York Heart Association classification (recent cerebrovascular accidents, myocardial infarction, coronary stenting or moderate to severe congestive heart failure), severe renal conditions (eg, patients on dialysis), neurological conditions (eg, demyelinating diseases), active major autoimmune diseases (eg, Eosinophilic granulomatosis with polyangitis (EGPA), lupus, inflammatory bowel disease, rheuma-toid arthritis, etc.), other severe endocrinological, gastrointestinal, hepatobiliary (e.g. Pugh type C, severe liver insufficiency), metabolic, pulmonary or lymphatic diseases
- •History or presence of epilepsy, significant neurological disorders, severe depression, suicidal ideation and behavior, cerebrovascular attacks or ischemia
- •Patients with an active, severe infection in anamnesis and a chronic infection should be excluded from the clinical trial
- •Presence of myocardial infarction (within the last 3 months) or cardiac arrhythmia requiring drug therapy in combination with a general increased risk of cardiovascular disease
- •On current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis, or hepatic failure, or has evidence of liver disease as indicated by persistent (confirmed by repeated tests ≥ 2 weeks apart) elevated transaminases (ala-nine aminotransferase [ALT] and/or aspartate aminotransferase [AST]) more than 2.5 times the upper limit of normal (ULN) during the screening period
- •Patients with a current or history of lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphade-nopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for less than 5 years: a) Patients with cervical carcinoma in situ that has been appropriately treated with no evidence of recurrence or metastatic disease for at least 3 years may participate in the study. b) Patients with basal cell or squamous epithelial skin cancers that have been appropriately treated with no evidence of recurrence for at least 3 years may participate in the study
- •History of allergy to any component of the study medication
- •History of alcohol or drug abuse within 2 years before the screening visit
- •Known history of human immunodeficiency virus (HIV) infection or HIV seropositivity
- •Current diagnosis of hepatitis B viral infection at the time of screening as evidenced by a) Positive hepatitis B surface antigen (HBsAg) OR b) Positive total hepatitis B core antibody (HBcAb) confirmed by positive HBV DNA
- •Current diagnosis of hepatitis C viral infection at the time of screening as evidence by a) Positive HCV Ab AND b) Positive HCV RNA
结局指标
主要结局
Therapeutic efficacy of deucravacitinib defined as the percentage of patients achieving a clinical response (Investigator Global Assessment 0 or 1) with ≥ 2-point improvement in IGA for patients with chronic hand eczema at week 16
Therapeutic efficacy of deucravacitinib defined as the percentage of patients achieving a clinical response (Investigator Global Assessment 0 or 1) with ≥ 2-point improvement in IGA for patients with chronic hand eczema at week 16
次要结局
- Evaluation of safety in terms of number of AE and lab parameters
- Quality of Life in Hand Eczema Questionnaire (QOLHEQ) [Time Frame: Baseline; Week 4, 8, 16]
- Hand eczema severity index (HECSI) [Time Frame: Baseline; Week 4, 8, 16]
- Participant self-assessment (PSA) [Time Frame: Baseline, week 2, 4, 6, 8, 12 and 16]
- Change in skin physiology from baseline to week 16
- Change in histology, in expression of skin barrier proteins, expression of cytokines, in extent of immune cells in skin biopsies, and the transcriptome from baseline to week 16
研究者
Philipp Globig
Scientific
Charite Universitaetsmedizin Berlin KöR
研究点 (4)
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