2024-513171-41-00招募中3 期
A Phase 3, Randomized, Double-Blind, Efficacy, and Safety Study of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Incyte Corp.
- 入组人数
- 202
- 试验地点
- 65
- 主要终点
- Proportion of participants achieving F-VASI75 at Week 24
研究概览
简要总结
To evaluate the efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment-extension period 28 weeks
- 盲法
- Double (Investigator, Monitor, Subject)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Ability to comprehend and willingness to sign an ICF or written informed consent of the legally designated representative and a verbal or written assent from the participant when possible
- •Aged 6 to < 12 years at the time of signing the ICF
- •Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI
- •Total body vitiligo area (facial and nonfacial) does not exceed 10% BSA
- •Pigmented hair within some of the areas of vitiligo on the face
- •Must agree to discontinue all agents used to treat vitiligo from screening through the safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted as per Section 6.6.
- •With the exception of participants who are prepubescent, willingness to avoid pregnancy or fathering children based on the criteria below. Permitted methods in preventing pregnancy (see Appendix A) should be communicated to the participants and their understanding confirmed. a. Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 90 days (a spermatogenesis cycle) after the last application of study cream. b. Female participants who have reached menarche must have a negative urine pregnancy test at screening and before the first application of study cream on Day 1 (if the interval between screening and Day 1 is > 2 weeks) and must agree to take appropriate precautions to avoid pregnancy from screening through 30 days (1 menstrual cycle) after the last application of study cream.
排除标准
- •Diagnosis of other forms of vitiligo (eg, segmental)
- •Pregnant or lactating or considering pregnancy during the period of study participation
- •In the opinion of the investigator, unable or unlikely to comply with the application schedule and study evaluations
- •Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study
- •Employees of the sponsor or investigator or are otherwise dependents of them
- •Known allergy or reaction to any component of the study cream formulation
- •The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code
- •In the EU, participants considered incapacitated according to EU CTR No. 536/2014 Articles 2 and 31
- •Other differential diagnosis of vitiligo or other skin depigmentation disorder (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor)
- •Any other skin disease that, in the opinion of the investigator, would interfere with study cream application or study assessments
- •Prior or current use of depigmentation treatments (eg, monobenzone)
- •Concurrent conditions and history of other diseases as follows: a. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome). b. History of malignant disease within 5 years before the Day 1 visit, except for adequately treated, nonmetastatic, nonmelanoma, skin cancer. c. Current and/or history of thrombosis, including deep venous thrombosis and pulmonary embolism. d. Current and/or history of liver disease, including known hepatitis B or C virus infection, with hepatic or biliary abnormalities. e. Current and/or history of HIV infection. f. Current and/or history of active tuberculosis; or current and/or history of latent tuberculosis unless adequately treated.
- •Any 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. Examples include but are not limited to the following: a. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the Day 1 visit. b. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox, clinically infected AD, impetigo) within 1 week before the Day 1 visit. c. Clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute myocardial infarction, or stroke within 6 months before the Day 1 visit; New York Heart Association Class III or IV congestive heart failure; or arrhythmia requiring therapy or uncontrolled hypertension (blood pressure > 150/90 mmHg), unless approved by the medical monitor/sponsor. d. On maintenance dialysis. e. Committed to an institution by virtue of an order issued by either judicial or administrative authorities
- •Use of any of the following treatments within the indicated washout period before Day 1: a. 1 week: Topical drugs (eg, corticosteroids, calcineurin and phosphodiesterase type 4 inhibitors, and retinoids) when used on the vitiligo areas. b. 2 weeks: Immunizations with live-attenuated vaccines. Note: Live-attenuated vaccines are not recommended during the double-blind, vehicle-controlled period. c. 4 weeks: − Melanocyte-stimulating agents (eg, afamelanotide). − Immunomodulating systemic medications (eg, corticosteroids, methotrexate, and cyclosporine). − Any other systemic therapies that could increase the skin sensitivity to UV/visible light or impact skin pigmentation (eg, tetracyclines and methoxypsoralens). d. 8 weeks: Laser or any kind of phototherapy, including tanning bed or intentional UV exposure. e. 5 half-lives or 12 weeks, whichever is longer, for any of the following if used to treat vitiligo: Biologic agents, investigational therapies, experimental therapies, or procedures. Investigational biologic agents should be discussed with the sponsor to determine whether a longer period of discontinuation is required
- •History of treatment failure with any systemic or topical JAK inhibitor (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, and upadacitinib) for vitiligo or any other inflammatory condition
- •Any of the following clinically significant, abnormal laboratory values at screening: a. Cytopenias: − Hemoglobin < 10 g/dL − Absolute neutrophil count < 1500/µL − Platelet count < 100,000/µL b. Liver function tests: − AST or ALT ≥ 2 × ULN − ALP and/or bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%) c. Estimated glomerular filtration rate < 30 mL/min/1.73 m (using the Revised (bedside) Schwartz equation). d. Clinically significant, abnormal TSH or free T4 as determined by the investigator. e. Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant.
结局指标
主要结局
Proportion of participants achieving F-VASI75 at Week 24
Proportion of participants achieving F-VASI75 at Week 24
次要结局
- Proportion of participants achieving F-VASI50 at Week 24
- Proportion of participants achieving F-VASI90 at Week 24
- Proportion of participants achieving T-VASI50 at Week 24
- Percentage change from baseline in F-BSA at Week 24
- AEs, assessed by changes in vital signs, clinical evaluations, height, weight, and laboratory data
- Proportion of participants achieving a VNS score of 4 (a lot less noticeable) or 5 (no longer noticeable) at Weeks 24 and 52
- Proportion of participants in each category for the color-matching question at Weeks 24 and 52
- Proportion of participants who report F-PaGIC-V of very much improved or much improved at Weeks 24 and 52
- Proportion of participants who report T-PaGIC-V of very much improved or much improved at Weeks 24 and 52
- Change from baseline in VIT-PIQ at Weeks 24 and 52
- Change from baseline in CDLQI at Weeks 24 and 52
- Change from baseline in PGIB-V at Weeks 24 and 52
- Mean satisfaction score at Weeks 24 and 52
- Preapplication plasma concentrations of ruxolitinib at Weeks 4, 24, 40, and 52
研究者
Clinical Trial Information Desk
Scientific
Incyte Corp.
研究点 (65)
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