Actively Recruiting
Study of Upadacitinib After Skin Cell Transplantation (NECS) in Vitiligo Participants A Pilot Randomized, Observer-Blinded Comparison of Upadacitinib Plus NECS Versus NECS Alone
Led by Jilin University · Updated on 2024-12-27
60
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of using upadacitinib after autologous non-cultured epidermal cell suspension transplantation (NECS) in people with vitiligo. The study aims to determine if a short course of upadacitinib following NECS can improve the results of the transplantation compared to NECS alone. Participants are divided into two groups: one group receives upadacitinib 15 mg once daily for 8 weeks after NECS, while the control group receives only NECS without the drug. This is a pilot, randomized, observer-blinded study comparing these two approaches. During the study, participants will attend scheduled visits for treatments, laboratory tests, and other procedures. Researchers will measure the Vitiligo Area Scoring Index (T-VASI) after 6 months to assess treatment effectiveness. Safety and adherence will also be monitored throughout the study period.
CONDITIONS
Official Title
Efficacy of Upadacitinib After NECS in Vitiligo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to sign informed consent
- Aged 18 to 60 years at the time of consent
- Diagnosed with non-segmented vitiligo
- Vitiligo area includes target flat lesions excluding hands, feet, perineum, lips, joints, perianal
- Total body surface area affected is 30% or less
- Vitiligo has been stable without new or expanding lesions for more than one year
- Women of childbearing potential willing to use effective contraception from consent through final follow-up
- Willing and able to attend all scheduled visits and follow study procedures
You will not qualify if you...
- Active skin conditions or infections that interfere with vitiligo assessment at screening
- Significant infection requiring hospitalization or treatment within one month before screening
- Infection with hepatitis B, hepatitis C, HIV, or syphilis
- Active or recently treated tuberculosis within the past year
- Liver dysfunction with elevated bilirubin or liver enzymes at screening
- Kidney impairment with eGFR below 45 mL/min or on dialysis at screening
- Current or past malignancy except treated nonmetastatic basal or squamous cell carcinoma
- Current thyroid disease or thyroid replacement therapy
- History of mental illness deemed unfit for study participation
- Pregnant or breastfeeding women
- Use of laser or phototherapy for vitiligo within 4 weeks before baseline
- Use of systemic or oral medications for vitiligo within 4 weeks before baseline
- Use of JAK inhibitors within 12 weeks or 5 half-lives before baseline
- Use of biologic agents within 12 weeks or 5 half-lives before baseline
- Participation in another clinical trial or treatment within 4 weeks before baseline
- Any other condition the investigator considers exclusionary
AI-Screening
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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
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