VitiligoNCT06454461
Efficacy of Upadacitinib After NECS in Vitiligo
A study testing Upadacitinib 15 MG in people with Vitiligo, run by Jilin University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Upadacitinib 15 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2024to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Dermatology and Venerology, The First Hospital of Jilin University, No. 1 Xinmin Street
Changchun, Jilin, 130021
Bing Han, MD, +86 15943073198, pfk_hanbing@jlu.edu.cn
About this study
Official title: 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.
- Conditions
- Vitiligo
- Being tested
- Upadacitinib 15 MG
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upadacitinib 15 MGDrug
Also called NECS
Upadacinib 15mg once daily for the 8 weeks after NECS
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | upadacitinib after autologous non-cultured epidermal cell suspension transplantation Receives: Drug: Upadacitinib 15 MG |
| B | No intervention | autologous non-cultured epidermal cell suspension transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-VASI
Percentage of change from baseline in target lesion Vitiligo Area Scoring Index (T-VASI) at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start4 Dec 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shanshan Li, Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454461
- Sponsor's protocol ID
- SLi
- Status last verified
- Aug 2024
- First submitted
- 6 Jun 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: SCI articles published after the end of the trial can be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Upadacitinib After Autologous Non-cultured Epidermal Cell Suspension Transplantation in Vitiligo Participants -- a Pilot, Random, Observer Blinded, Comparative Study
- ClinicalTrials.gov ID
- NCT06454461
- Acronym / sponsor ID
- SLi
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jilin UniversityUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Upadacitinib 15 MGupadacitinib after autologous non-cultured epidermal cell suspension transplantation |
| B | No intervention | –autologous non-cultured epidermal cell suspension transplantation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upadacitinib 15 MGAlso: NECSUpadacinib 15mg once daily for the 8 weeks after NECS | Drug | A |
Primary outcome
T-VASI
Time frame: 6 months
Percentage of change from baseline in target lesion Vitiligo Area Scoring Index (T-VASI) at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No. SCI articles published after the end of the trial can be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upadacitinib 15 MG in people with Vitiligo, run by Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bing Han (+86 159 4307 3198, pfk_hanbing@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T-VASI (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.