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临床试验/NCT05456529
NCT05456529已完成3 期

A Phase 3, Open-Label, One-Year Safety Study of Ruxolitinib Cream in Adolescents (Ages ≥ 12 Years to < 18 Years) With Atopic Dermatitis

Incyte Corporation38 个研究点 分布在 3 个国家目标入组 103 人开始时间: 2022年9月1日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
103
试验地点
38
主要终点
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the long-term safety and tolerability of ruxolitinib cream in adolescents with Atopic Dermatitis (AD).

详细描述

The study comprises of a 8 week continuous treatment period followed by 44 week Long Term Safety (LTS) period and 30 days safety follow up period. During Continuous treatment period all lesions identified at baseline will be treated and during LTS period only active lesions will be treated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 17 Years（Child）
性别
All
接受健康志愿者
否

入选标准

  • •A diagnosis of Atopic Dermatitis (AD) as defined by the Hanifin and Rajka (1980) criteria.
  • •Duration of AD of at least 2 years.
  • •Total IGA score of 2 to 3 at the screening and baseline visits.
  • •Percent BSA (excluding the scalp) with AD involvement of 3% to 20% at the screening and baseline visits.
  • •Atopic dermatitis not adequately controlled with other topical prescription therapies or when those therapies are not advisable.
  • •Agree to discontinue all agents used to treat AD from screening through the final follow up visit.
  • •Willingness to avoid pregnancy or fathering children.

排除标准

  • •An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
  • •Concurrent conditions and history of other diseases
  • •Any current and/or history of serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including application of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. For example:
  • •Clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute myocardial infarction or stroke within 6 months from Day 1 of study cream application, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy or uncontrolled hypertension (blood pressure > 150/90 mm Hg) unless approved by the medical monitor/sponsor.
  • •Current and/or history of malignancy in the 5 years preceding the baseline visit, except for adequately treated, nonmetastatic nonmelanoma skin cancer.
  • •Current and/or history of arterial or venous thrombosis, including DVT and PE.
  • •Current and/or history of active tuberculosis or current and/or history of latent tuberculosis unless adequately treated.
  • •Any of the following clinical laboratory test results at screening:
  • •Hemoglobin < 100 g/L (< 10 g/dL)
  • •Liver function tests:
  • •AST or ALT ≥ 2.5 × ULN
  • •Total bilirubin > 1.5 × ULN with the exception of Gilbert disease. c. Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (using the CKD Epidemiology Collaboration equation).
  • •d. Positive serology test results for HIV antibody. e. Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant.
  • •Use of any of the following treatments within the indicated washout period before baseline:
  • •5 half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab).
  • •4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus).
  • •2 weeks - immunizations with live-attenuated vaccines; sedating antihistamines, unless on long-term stable regimen (nonsedating antihistamines are permitted).
  • •Note: Live-attenuated vaccines are not recommended during the CT period. Note: COVID-19 vaccination is allowed.
  • •1 week - use of other topical treatments for AD (other than bland emollients, eg, Aveeno® creams, ointments, sprays, soap substitutes), such as topical antipruritics (eg, doxepin cream), corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), antibiotics, or antibacterial cleansing body wash/soap.
  • •Note: Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study.
  • •Previously received systemic or topical JAK inhibitors (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
  • •Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's AD.
  • •Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before baseline with another investigational medication or current enrollment in another investigational drug protocol.
  • •Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before baseline with a strong CYP3A4 inhibitor.
  • •Inability to draw blood for PK analysis from any nonlesional areas.
  • •Known allergy or reaction to any component of the study cream formulation.
  • •In the opinion of the investigator unable or unlikely to comply with the administration schedule and study evaluations.
  • •Further exclusion criteria may apply.

研究组 & 干预措施

Ruxolitinib

Experimental

Ruxolitinib cream 1.5% twice daily (BID) during the continuous and LTS treatment period.

干预措施: Ruxolitinib Cream (Drug)

结局指标

主要结局

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

时间窗: up to 462 days

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of study cream and up to 30 days after the last application of study cream.

Number of Participants With ≥Grade 3 TEAEs

时间窗: up to 462 days

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was drug related. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of study cream and up to 30 days after the last application of study cream. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.

次要结局

  • LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing(from Week 9 up to Week 52 (44 weeks))
  • Change From Baseline in Body Temperature at Weeks 8, 44, and 52(Baseline; Weeks 8, 44, and 52)
  • CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing(up to Week 8)
  • CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing(up to Week 8)
  • CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing(up to Week 8)
  • CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing(up to Week 8)
  • CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing(up to Week 8)
  • CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing(up to Week 8)
  • LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing(from Week 9 up to Week 52 (44 weeks))
  • LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing(from Week 9 up to Week 52 (44 weeks))
  • LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing(from Week 9 up to Week 52 (44 weeks))
  • LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing(from Week 9 up to Week 52 (44 weeks))
  • Change From Baseline in Height at Weeks 8 and 52(Baseline; Weeks 8 and 52)
  • LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing(from Week 9 up to Week 52 (44 weeks))
  • CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing(up to Week 8)
  • CT Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing(up to Week 8)
  • CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing(up to Week 8)
  • CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing(up to Week 8)
  • CT Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing(up to Week 8)
  • LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing(from Week 9 up to Week 52 (44 weeks))
  • LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing(from Week 9 up to Week 52 (44 weeks))
  • LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing(from Week 9 up to Week 52 (44 weeks))
  • LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing(from Week 9 up to Week 52 (44 weeks))
  • LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing(from Week 9 up to Week 52 (44 weeks))
  • Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52(Baseline; Weeks 8, 44, and 52)
  • Change From Baseline in Pulse at Weeks 8, 44, and 52(Baseline; Weeks 8, 44, and 52)
  • Change From Baseline in Respiration Rate at Weeks 8, 44, and 52(Baseline; Weeks 8, 44, and 52)
  • Change From Baseline in Weight at Weeks 8 and 52(Baseline; Weeks 8 and 52)
  • Plasma Concentration of Ruxolitinib(prior to study cream application at Weeks 2 and 4)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (38)

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