Efficacy of Upadacitinib After NECS in Vitiligo

Inclusion 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 ≤30% 5. Clinically stable for more than one year (stable refers to the original lesion no longer expanding and no new lesions appearing).

• 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.

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

Exclusion criteria

• 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 period or an active infection for which they were receiving treatment during the screening period.
• 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 baseline.
• 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.