2025-523635-19-00招募中2 期
Open-label proof-of-concept trial of topical delgocitinib in patients with facial vitiligo
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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 open-label proof-of-concept trial primarily aims to define whether delgocitinib cream is a potential treatment for patients with non-segmental vitiligo in the facial area.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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 Exclusion criteria 9─16)
- •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
排除标准
- •Disease duration of more than 10 years in the area chosen for treatment
- •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)
- •Signs of follicular repigmentation in the area chosen for treatment
- •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
- •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
结局指标
主要结局
Change in F-VASI from baseline to Week 24
Change in F-VASI from baseline to Week 24
次要结局
- Change in T-VASI from baseline to Week 24
- Change in VESplus from baseline to Week 24
- Change in VETF score from baseline to Week 24
- Change in facial BSA from baseline to Week 24
- Change in total BSA from baseline to Week 24
- F-VASI50 at Week 24
- F-VASI75 at Week 24
- F-VASI90 at Week 24
- Change in T-VASI at Weeks 4 and 12
- Change in VESplus at Weeks 4 and 12
- Change in VETF score at Weeks 4 and 12
- F-VASI50 at Weeks 4 and 12
- F-VASI75 at Weeks 4 and 12
- F-VASI90 at Weeks 4 and 12
- Change in DQOL from baseline to Week 24
- Change in VitiQoL from baseline to Week 24
- Change in WHO-5 from baseline to Week 24
- Change in DQOL at Weeks 4 and 12
- Change in VitiQoL at Weeks 4 and 12
- Change in WHO-5 at Weeks 4 and 12
- Frequency, duration, and severity of AEs
- Changes in skin proteome and transcriptome from baseline to Weeks 4 and 24 (analyses will be performed if a change in F-VASI is shown)
研究者
Lone Skov
Scientific
Gentofte Hospital
研究点 (1)
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