Actively Recruiting
Efficacy of Upadacitinib After Autologous Non-cultured Epidermal Cell Suspension Transplantation in Vitiligo Participants A Pilot, Random, Observer Blinded, Comparative Study
Led by Jilin University · Updated on 2024-12-27
60
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well upadacitinib works after autologous non-cultured epidermal cell suspension transplantation (NECS) in people with vitiligo. The main goal is to see if taking upadacitinib for a short time after NECS improves the treatment's effectiveness. This study compares participants receiving upadacitinib after NECS with those receiving NECS alone. Participants are divided into two groups: one group receives upadacitinib 15 mg once daily for 8 weeks after NECS, and the other group receives only the NECS transplantation. The study is randomized and observer blinded, meaning participants are randomly assigned to groups, and observers do not know which treatment is given. This setup helps to compare the effects of adding upadacitinib to the standard treatment. During the study, participants will have scheduled visits where their vitiligo areas are assessed using the T-VASI score over 6 months. Researchers will monitor treatment effects and safety throughout this period. Participants must adhere to visits, treatments, lab tests, and other study procedures. The total participation time includes the treatment period and follow-up assessments to evaluate the treatment outcomes.
CONDITIONS
Brief Title
Efficacy of Upadacitinib After NECS in Vitiligo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who can sign the informed consent.
- Participants aged 18 to 60 years (both men and women) at the time of signing the informed consent.
- Diagnosed with non-segmented vitiligo.
- Vitiligo affected area includes target areas that are relatively flat and excludes hands, feet, perineum, lips, joints, and perianal regions.
- Total body surface area involvement of 30% or less.
- Clinically stable vitiligo for more than one year, with no expanding or new lesions.
- Fertile women willing to use at least one highly effective contraception method during the study.
- Willing and able to follow scheduled visits, treatments, laboratory tests, and study procedures.
You will not qualify if you...
- Presence of any active skin lesions or skin infections that could affect vitiligo assessment.
- Recent serious infections requiring hospitalization or ongoing infection treatment.
- Infection with HBV, HCV, HIV, or syphilis.
- Active tuberculosis or recent anti-tuberculosis treatment within one year.
- Liver dysfunction with elevated bilirubin or liver enzymes.
- Kidney impairment with eGFR below 45 mL/min or dialysis.
- History of malignancy except certain treated skin cancers.
- Current thyroid disease or thyroid replacement therapy.
- Mental illness deemed unfit for study participation.
- Pregnant or lactating women.
- Recent laser or phototherapy for vitiligo within 4 weeks before baseline.
- Recent use of oral or systemic medications for vitiligo within 4 weeks before baseline.
- Prior JAK inhibitor therapy within 12 weeks or 5 half-lives before baseline.
- Recent use of biologic agents within 12 weeks or 5 half-lives before baseline.
- Participation in another intervention trial within 4 weeks before baseline.
- Any other condition deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants receive autologous non-cultured epidermal cell suspension transplantation. Those in the experimental group take Upadacitinib 15 mg once daily for 8 weeks after transplantation.
Duration - Up to 6 months
Participants are monitored for treatment outcomes and safety up to 6 months after transplantation.
Trial Site Locations
Total: 1 location
1
Department of Dermatology and Venerology, The First Hospital of Jilin University, No. 1 Xinmin Street
Changchun, Jilin, China, 130021
Actively Recruiting
Research Team
B
Bing Han
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here