Efficacy of Upadacitinib After NECS in Vitiligo

Efficacy of Upadacitinib After Autologous Non-cultured Epidermal Cell Suspension Transplantation in Vitiligo Participants -- a Pilot, Random, Observer Blinded, Comparative Study

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. Participants in the experimental group will receive upadacitinib after NECS, while Participants in the control group will receive NECS only.

Study Overview

• Status: Recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Drug: Upadacitinib 15 MG

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bing Han; Phone Number: +86 159 4307 3198; Email: pfk_hanbing@jlu.edu.cn

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • Department of Dermatology and Venerology, The First Hospital of Jilin University, No. 1 Xinmin Street
      • Contact: Bing Han, MD; Phone Number: +86 15943073198; Email: pfk_hanbing@jlu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants who can sign the informed consent.
2. Participants aged 18-60 years (both men and women) at the time of signing the informed consent.
3. Non-segmented vitiligo
4. 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 ≤30% 5. Clinically stable for more than one year (stable refers to the original lesion no longer expanding and no new lesions appearing).

6. All fertile women had to be willing to use at least one highly effective method of contraception from the time they signed informed consent through the final follow-up visit.

7. Participants must be willing and able to adhere to scheduled visits and scheduled treatments, laboratory tests, and other study procedures.

Exclusion Criteria:

1. 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.
2. 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 period or an active infection for which they were receiving treatment during the screening period.
3. Infected with HBV or HCV or HIV or syphilis.
4. Participants had active Tuberculosis or were receiving anti-Tuberculosis treatment, or had received anti-Tuberculosis treatment within 1 year.
5. Hepatic dysfunction (Total bilirubin ≥ 2 × ULN, AST≥2 × ULN, ALT ≥ 2 × ULN) at screening.
6. Renal impairment ( eGFR of <45 mL/min or receiving dialysis) at screening
7. Participants with malignancy or with a history of malignancy other than adequately treated or resected nonmetastatic basal cell carcinoma or squamous cell carcinoma.
8. Participants with current thyroid disease or undergoing thyroid replacement therapy.
9. 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.
10. Pregnant or lactating female participants.
11. Participants who received any laser or phototherapy for vitiligo within 4 weeks before baseline.
12. 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 baseline.
13. 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.
14. Participants who had used any biologic agent within 12 weeks or 5 half-lives before baseline, whichever was longer.
15. 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.
16. Any other condition that the investigator considered might render the subject ineligible for inclusion in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; upadacitinib after autologous non-cultured epidermal cell suspension transplantation	Drug: Upadacitinib 15 MG; Upadacinib 15mg once daily for the 8 weeks after NECS; Other Names: NECS
No Intervention: B; autologous non-cultured epidermal cell suspension transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
T-VASI	Percentage of change from baseline in target lesion Vitiligo Area Scoring Index (T-VASI) at 6 months	6 months

Collaborators and Investigators

• Sponsor: Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 25, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hypopigmentation; Pigmentation Disorders; Vitiligo; Janus Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Protein Kinase Inhibitors; Upadacitinib
• Other Study ID Numbers: SLi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: SCI articles published after the end of the trial can be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No