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Study 2, Period A: Group 1 for Vitiligo (Viti-Up Trial)

Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented clinical diagnosis of non-segmented vitiligo (NSV).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights

Viti-Up Trial Summary

This trial will evaluate if the drug upadacitinib is safe and effective in treating vitiligo, a chronic autoimmune skin disease. 540 participants will be enrolled worldwide to receive either upadacitinib or a placebo in Period A, followed by upadacitinib in Period B.

Who is the study for?
Adults and adolescents with non-segmental vitiligo (NSV) who have tried at least one topical treatment without success or show signs of actively worsening vitiligo can join. They must have a certain amount of skin affected but not too much, as measured by specific scales.Check my eligibility
What is being tested?
The trial is testing Upadacitinib, an oral tablet for autoimmune diseases, against a placebo to see if it's safe and effective for NSV. Participants are randomly assigned to get either the drug or placebo in Period A for 48 weeks; everyone gets Upadacitinib in Period B for 112 weeks.See study design
What are the potential side effects?
Possible side effects include reactions typical of immune system medications like infections, liver issues, blood problems, allergies, and others that will be monitored through medical assessments and blood tests.

Viti-Up Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with non-segmented vitiligo.

Viti-Up Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Achieving Facial-Vitiligo Area Scoring Index (F-VASI) 75 (≥ 75% Improvement in F-VASI From Baseline)
Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline)
Secondary outcome measures
Percent Change From Baseline in T-VASI
Percent Change from Baseline in F-VASI
Percentage of Participants Achieving 3D Imaging Facial Vitiligo 40 (≥ 40% Reduction in Facial Vitiligo Area Measured by 3D Digital Imaging from Baseline) (Study 1 Only)
+6 more

Side effects data

From 2023 Phase 3 trial • 613 Patients • NCT03086343
6%
URINARY TRACT INFECTION
5%
UPPER RESPIRATORY TRACT INFECTION
5%
NASOPHARYNGITIS
3%
HYPERTENSION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abatacept
Upadacitinib 15 mg

Viti-Up Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Study 2, Period B: Extension PeriodExperimental Treatment1 Intervention
Participants will receive upadacitinib 15 mg once daily for 112 weeks.
Group II: Study 2, Period A: Group 1Experimental Treatment1 Intervention
Participants will receive upadacitinib 15 mg once a day for 48 weeks.
Group III: Study 1, Period B: Extension PeriodExperimental Treatment1 Intervention
Participants will receive upadacitinib 15 mg once daily for 112 weeks.
Group IV: Study 1, Period A: Group 1Experimental Treatment1 Intervention
Participants will receive upadacitinib 15 mg once a day for 48 weeks.
Group V: Study 2, Period A: Group 2Placebo Group1 Intervention
Participants will receive placebo once a day for 48 weeks.
Group VI: Study 1, Period A: Group 2Placebo Group1 Intervention
Participants will receive placebo once daily for 48 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
2014
Completed Phase 3
~9670

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
954 Previous Clinical Trials
500,565 Total Patients Enrolled
1 Trials studying Vitiligo
185 Patients Enrolled for Vitiligo
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,399 Total Patients Enrolled
1 Trials studying Vitiligo
185 Patients Enrolled for Vitiligo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals are most sought after in this particular experiment?

"AbbVie, the trial sponsor, has specified that Percentage of Participants Achieving Facial-Vitiligo Area Scoring Index (F-VASI) 75 (≥ 75% Improvement in F-VASI From Baseline) will be observed for 48 weeks as the primary outcome. Secondary outcomes include Percent Change from Baseline in F-VASI and Percentage of Participants Achieving Patient Global Impression of Noticeability (PGIN) Score of "Not Noticeable at All (0)" or "A Little Noticeable (1)" For Participants with a Score of "Moderately Noticeable"

Answered by AI

Are there any opportunities for patients to join this research effort?

"Clinicaltrials.gov does not show this trial actively seeking participants, as its last update was on December 11th 2023. Nevertheless, there are currently 35 other active trials recruiting patients."

Answered by AI

Has the FDA sanctioned Study 1, Period B: Extension Period?

"Analysis conducted by the Power team concluded that Study 1, Period B: Extension period should be given a safety rating of 3. This score was based on evidence from Phase 3 trials demonstrating both efficacy and multiple rounds of established safety."

Answered by AI

Who else is applying?

What site did they apply to?
Cleaver Medical Group Dermatology - Dawsonville /ID# 259925
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I have tried another treatment and it didn't work.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo
2023. "A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06118411.
All > Vitiligo
~360 spots leftby Feb 2027
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