EUCTR2021-000361-32-FR招募中1 期
A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Mechanism of Action of Ruxolitinib Cream for Vitiligo (TRuE-V MOA) - TRuE-V MOA
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
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
- 性别
- All
入选标准
- •1. Age = 18 years.
- •2. A clinical diagnosis of nonsegmental vitiligo with depigmented areas including = 0.5% BSA on the face, = 0.5 F-VASI, = 3% BSA on nonfacial areas, and = 3 T-VASI; total body vitiligo area (facial and nonfacial) should not exceed 50% BSA.
- •3. At least 1 active vitiligo lesion (eg, such as confetti lesion, trichrome appearance, pinkish rim, or other evidence of inflammatory activity) at the site for skin biopsy.
- •4. Agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
- •5. Willingness to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation with the exception of the following:
- •a. Female participants of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR postmenopausal [= 12 months of amenorrhea without an alternative medical cause]).
- •6. Ability to comprehend and willingness to sign an ICF.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. No pigmented hair within any of the vitiligo areas on the face.
- •2. Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
- •3. Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
- •4. Concurrent conditions and history of other diseases:
- •a. Any other skin disease that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
- •b. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox) within 1 week before baseline.
- •c. Conditions at baseline that would interfere with evaluation of vitiligo.
- •d. 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 administration of study drug 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:
- •- Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug
- •administration, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy or uncontrolled hypertension (blood pressure > 150/90 mmHg) unless approved by the medical monitor/sponsor.
- •- History of thrombosis, including deep venous thrombosis and pulmonary embolism.
- •- Concurrent malignant disease or a history of that in the 5 years preceding the baseline visit except for adequately treated nonmetastatic malignancies.
- •- Current and/or history of liver disease, including known hepatitis B or C, with hepatic or biliary abnormalities.
- •- Current and/or history of tuberculosis.
- •- History of alcohol use disorder or drug addiction within 1 year before screening or current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the administration schedule and study assessments.
- •- Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- •5. Use of any of the following treatments within the indicated washout period before baseline:
- •a. 1 week: Topical drugs when used on the vitiligo areas, for example, corticosteroids, calcineurin, and phosphodiesterase type 4 inhibitors or retinoids.
- •b. 4 weeks:
- •- Melanocyte-stimulating agents (eg, afamelanotide).
- •- Immunomodulating systemic medications (eg, corticosteroids, methotrexate, cyclosporine).
- •- Any other systemic therapies that could increase the skin sensitivity to UV/visible light or impact skin pigmentation, for example, tetracyclines, methoxypsoralens.
- •- Received live vaccine.
- •c. 8 weeks: Laser or any kind of phototherapy, including tanning beds or intentional UV exposure.
- •d. 5 half-lives or 12 weeks, whichever is longer: biologic agents, investigational or experimental therapy, or procedures for vitiligo. Investigational biologics should be discussed with the sponsor to determine whether a longer period of discontinuation is required.
- •6. Previously received JAK inhibitors, systemic or topical.
- •7. Investigator-determined clinically sig
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