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Tests treatment safety and results for Vitiligo
Official title Efficacy of Upadacitinib After NECS in Vitiligo
ClinicalTrials.gov ID: NCT06454461
What this study is testing
What is Upadacitinib 15 MG?
Upadacitinib 15 MG is an investigational medicine, given as an once-daily, being studied as a potential treatment for vitiligo.
Also referred to as NECS.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to investigate the efficacy of upadacitinib after NECS in participants with vitiligo. The main question it aims to answer is: whether the short time use of upadacitinib after NECS will improve NECS efficacy.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Participants who can sign the informed consent.
- Participants aged 18-60 years (both men and women) at the time of signing the informed consent.
- Non-segmented vitiligo
- Vitiligo affected area should meet the following two criteria: (1) containing the target area (relatively flat vitiligo lesions except of the hands...
You likely can't join if
- Any active skin lesions (e.g. psoriasis, dermatitis, skin ulceration, etc.) or skin infections (bacterial, fungal, viral, etc.) which may interfere...
- Participants had a clinically significant infection (requiring hospitalization and parenteral treatment with antibiotics, antiviral agents, or...
- Infected with HBV or HCV or HIV or syphilis.
- Participants had active Tuberculosis or were receiving anti-Tuberculosis treatment, or had received anti-Tuberculosis treatment within 1 year.
- Hepatic dysfunction (Total bilirubin ≥ 2 × ULN, AST≥2 × ULN, ALT ≥ 2 × ULN) at screening.
- Renal impairment ( eGFR of \<45 mL/min or receiving dialysis) at screening
See the full eligibility criteria
- Participants who can sign the informed consent.
- Participants aged 18-60 years (both men and women) at the time of signing the informed consent.
- Non-segmented vitiligo
- Vitiligo affected area should meet the following two criteria: (1) containing the target area (relatively flat vitiligo lesions except of the hands and feet, perineum, lips, joints, perianal); (2) total BSA involvement...
- Any active skin lesions (e.g. psoriasis, dermatitis, skin ulceration, etc.) or skin infections (bacterial, fungal, viral, etc.) which may interfere with the assessment of vitiligo at screening.
- Participants had a clinically significant infection (requiring hospitalization and parenteral treatment with antibiotics, antiviral agents, or antifungal agents for more than 3 days) within one month of the screening...
- Infected with HBV or HCV or HIV or syphilis.
- Participants had active Tuberculosis or were receiving anti-Tuberculosis treatment, or had received anti-Tuberculosis treatment within 1 year.
- Hepatic dysfunction (Total bilirubin ≥ 2 × ULN, AST≥2 × ULN, ALT ≥ 2 × ULN) at screening.
- Renal impairment ( eGFR of \<45 mL/min or receiving dialysis) at screening
- Participants with malignancy or with a history of malignancy other than adequately treated or resected nonmetastatic basal cell carcinoma or squamous cell carcinoma.
- Participants with current thyroid disease or undergoing thyroid replacement therapy.
- Participants with a history of mental illness, such as anxiety or depression, who were assessed by the investigator to be unfit to participate in the study.
- Pregnant or lactating female participants.
- Participants who received any laser or phototherapy for vitiligo within 4 weeks before baseline.
- Participants who received oral or systemic medications (e.g., glucocorticoids, cyclosporine, methotrexate, tacrolimus, Chinese medicine, etc.) aimed at controlling/improving vitiligo symptoms within 4 weeks before...
- Participants who had received JAK inhibitor therapy (including, but not limited to Ruxolitinib, Tofacitinib, Baricitinib, Upadacinib, etc.) within 12 weeks or 5 half-lives before baseline, whichever was longer.
- Participants who had used any biologic agent within 12 weeks or 5 half-lives before baseline, whichever was longer.
- Participants who had been enrolled in another intervention clinical trial within 4 weeks before the baseline visit or who were within 5 half-lives of the last dose of the intervention drug at baseline.
- Any other condition that the investigator considered might render the subject ineligible for inclusion in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changchun, Jilin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.