Open-label Proof-of-concept Trial of Topical Delgocitinib in Patients With Facial Vitiligo
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in F-VASI from baseline to Week 24
研究概览
简要总结
This study is looking at a skin condition called vitiligo. Vitiligo is a skin condition where patches of the skin lose their natural color and become white. This study focuses specifically on vitiligo that affects the face. The treatment being tested is a cream called Anzupgo, which contains an active ingredient named delgocitinib. This cream is applied directly to the skin in the areas affected by vitiligo.The purpose of this study is to find out whether delgocitinib cream could be a helpful treatment for people who have non-segmental vitiligo on their face. During the study, participants will apply the cream to their facial vitiligo patches twice daily for a period of 24 weeks. The study will measure changes in the amount and appearance of the white patches on the face and other parts of the body after 4 weeks, 12 weeks, and 24 weeks of treatment.Throughout the study, doctors will check how well the treatment works by examining the size and severity of the vitiligo patches. They will also ask participants questions about how vitiligo affects their quality of life. The study will monitor any unwanted effects that might occur during treatment and at a follow-up visit 12 weeks after completion of the treatment period. Participants will have skin tape strips taken at the beginning of the study and during treatment to help researchers understand how the cream works on the skin.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Able to provide written informed consent
- •Age 18 years or above at screening
- •Ability to understand, speak, and read Danish, as assessed by the investigator
- •Have a clinical diagnosis of non-segmental vitiligo with facial involvement corresponding to at least 0.5% of total BSA
- •Agree not to use any other agent used to treat vitiligo from screening through the final visit (also please see
排除标准
- •Able and willing to follow trial procedures including application of trial medication to facial vitiligo lesions
- •A WOCBP* must agree to use an acceptable method of birth control** throughout the trial up until the last application of the trial treatment
- •*A woman is defined as not being of childbearing potential if she is postmenopausal (at least 12 months with no menses without an alternative medical cause prior to screening), or surgically sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).
- •Exclusion Criteria:
- •1. Disease duration of more than 10 years in the area chosen for treatment
- •Signs of follicular repigmentation in the area chosen for treatment
- •Concurrent skin diseases in the face
- •Other active skin diseases requiring medical treatment
- •Other forms of vitiligo (e.g., segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (e.g., piebaldism, pityriasis alba, leprosy, post inflammatory hypopigmentation, progressive macule hypomelanosis, idiopathic guttate hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor)
- •Patients who have no pigmented hair within any of the vitiligo areas on the face
- •Clinically significant bacterial, viral, or fungal skin infection in the face within one week before baseline
- •Known or suspected hypersensitivity to any components of the trial drug
- •Previous or current treatment with JAK inhibitors (including delgocitinib), systemic or topical
- •Treatment with any marketed biological therapy or investigational biologic agents within 12 weeks or 5-lives, whichever is longer, prior to baseline
- •Systemic treatment with immunosuppressive or immunomodulating drugs within 12 weeks prior to baseline
- •Use of tanning beds, phototherapy, or intentional UV exposure within 12 weeks prior to baseline
- •Cutaneous applied treatment with topical corticosteroids or other immunomodulators such as phosphodiesterase type 4 inhibitors or calcineurin inhibitors within four weeks prior to baseline
- •Any systemic or topical therapies that could increase the skin sensitivity to UV/visible light or impact skin pigmentation, that is, retinoids, tetracyclines within four weeks prior to baseline
- •Any depigmentation treatments for past treatment of vitiligo or other pigmented areas
- •Surgical or laser treatments in the facial area within 12 weeks prior to baseline
- •History of any known primary immunodeficiency disorder
- •Planned hospitalization during the trial period
- •History of cancer (for skin cancer in the facial area, the patient is NOT eligible; for skin cancer outside of the facial area, a patient is eligible if in remission and curative therapy has been completed ≥12 months prior to screening; for other malignancies, a patient is eligible if in remission and curative therapy has been completed ≥5 years prior to screening)
- •Any unstable disorder that could affect the safety of the patient throughout the trial or impede the patient's ability to complete the trial
- •Any clinically abnormal finding observed during the screening period that could affect the safety of the patient or influence the ability to complete the trial
- •Any significant illness or medical, physical, or psychiatric condition that, in the opinion of the investigator, could hinder the participant's ability to fully engage in the study-such as receiving the trial medication or attending scheduled visits-pose a notable risk to their health, or compromise the integrity of the trial data
- •Current participation in any other interventional clinical trial
- •Current or recent chronic alcohol or drug abuse, or any other condition associated with poor compliance as judged by the investigator
- •Women who are pregnant or breastfeeding, or women considering pregnancy during the period of their trial participation
研究组 & 干预措施
One arm open label proof of concept
干预措施: Delgocitinib cream (Drug)
结局指标
主要结局
Change in F-VASI from baseline to Week 24
时间窗: baseline to Week 24
次要结局
- Change in WHO-5(Baseline, week 4, week 12, week 24)
- Frequency, duration, and severity of AEs(baseline, week 4, week 12, week 24)
- Decrease of at least 50% in the F-VASI (F-VASI50)(Baseline, week 4, week 12, week 24)
- Decrease of at least 75% in the F-VASI (F-VASI75)(Baseline, week 4, week 12, week 24)
- Decrease of at least 90% in the F-VASI (F-VASI90)(Baseline, week 4, week 12, week 24)
- Change in DLQI(Baseline, week 4, week 12, week 24)
- Change in VitiQoL(Baseline, week 4, week 12, week 24)
- Change in T-VASI(Baseline, week 4, week 12, week 24)
- Change in VETF score(Baseline, week 4, week 12, week 24)
- Change in percentage of total and facial BSA vitiligo(Baseline, week 4, week 12, week 24)
研究者
Lone Skov
Prof MD
Gentofte Hospital