Using Upadacitinib to Improve Vitiligo Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy of upadacitinib, a medication, administered after non-epidermal cell suspension (NECS) in patients with vitiligo. Participants will be divided into two groups: one receiving upadacitinib following NECS and the other receiving NECS alone. The study aims to determine if the addition of upadacitinib enhances the effectiveness of NECS in treating vitiligo. The trial will include adults aged 18-60 with stable, non-segmented vitiligo and specific criteria for affected skin areas.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Dermatology and Venerology, The First Hospital of Jilin University, No. 1 Xinmin Street
  Changchun, Jilin, China Recruiting

Study contacts

• Study coordinator: Bing Han
• Email: pfk_hanbing@jlu.edu.cn
• Phone: +86 159 4307 3198

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• crisaborole 2% versus tacrolimus 0.1% with light therapy for facial vitiligo

  This study tests whether applying crisaborole 2% ointment can improve stable facial vitiligo in children and adults and whether it is as safe and effective as tacrolimus 0.1% when combined with light therapy.

  Recruiting Phase 3 Cairo University · Cairo · NCT07904910

• Imaging vitiligo lesions with polarized, sub-ultraviolet, and ultraviolet dermoscopy

  This study tests whether advanced light-based skin imaging can reveal details of vitiligo spots in adults more clearly than standard polarized dermoscopy.

  Recruiting Istanbul Training and Research Hospital · Istanbul · NCT07846969

• Safety and drug level study of multiple doses of upadacitinib, tofacitinib, and baricitinib in healthy adults

  This early-phase study tests how different doses of upadacitinib, tofacitinib, and baricitinib behave in healthy adults to understand safety and how the drugs act in the body.

  Recruiting Phase 1 AbbVie · Grayslake, Illinois · NCT07843693

• Upadacitinib for Severe Alopecia Areata in Children

  This study tests whether upadacitinib can safely help children with severe alopecia areata grow back hair, compared with placebo.

  Recruiting at 14 sites Phase 3 AbbVie · Los Angeles, California and 13 other locations · NCT07772492

• MH004 Ointment in non-segmental vitiligo: a phase 3 trial

  A 12-month randomized trial tests MH004 ointment to see if it helps facial vitiligo more than a placebo in people aged 12 to 75.

  Recruiting Phase 3 Minghui Pharmaceutical (Hangzhou) Ltd · Beijing, Beijing Municipality · NCT07682506

• NSV: Vitiligo Drug Safety and Effectiveness Registry for Adults and Teens

  This registry tracks adults and teens with nonsegmental vitiligo to see how usual treatments work and how safe they are over time in real-world dermatology care.

  Recruiting CorEvitas · Waltham, Massachusetts · NCT07659418

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.