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Upadacitinib 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
Pivotal 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.
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.
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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 • 657 Patients • NCT03086343
24%
UPPER RESPIRATORY TRACT INFECTION
24%
HYPERTENSION
18%
BRONCHITIS
12%
ACUTE RESPIRATORY FAILURE
12%
RASH
12%
WEIGHT INCREASED
12%
INFLUENZA
12%
FALL
12%
ARTHRALGIA
12%
MUSCLE SPASMS
12%
SINUSITIS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
URINARY TRACT INFECTION
12%
OROPHARYNGEAL PAIN
12%
LIVER FUNCTION TEST INCREASED
6%
PARAESTHESIA
6%
DEHYDRATION
6%
NASAL CONGESTION
6%
PULMONARY EMBOLISM
6%
SWELLING
6%
HYPONATRAEMIA
6%
CONSTIPATION
6%
RHEUMATOID ARTHRITIS
6%
RHINORRHOEA
6%
LEUKOCYTOSIS
6%
PATELLA FRACTURE
6%
PERIPHERAL SWELLING
6%
BLOOD PRESSURE INCREASED
6%
COUGH
6%
BONE CONTUSION
6%
HIP FRACTURE
6%
VOMITING
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
ORAL CANDIDIASIS
6%
STAPHYLOCOCCAL INFECTION
6%
HERPES ZOSTER
6%
PNEUMONIA
6%
FEELING HOT
6%
HEADACHE
6%
HAEMOGLOBIN DECREASED
6%
LIGAMENT RUPTURE
6%
PHOTODERMATOSIS
6%
PNEUMONIA BACTERIAL
6%
FEMUR FRACTURE
6%
STOMATITIS
6%
SKIN LACERATION
6%
HYPOKALAEMIA
6%
GLAUCOMA
6%
BACTERIAL SEPSIS
6%
CHEST PAIN
6%
FATIGUE
6%
ATRIOVENTRICULAR BLOCK FIRST DEGREE
6%
CANDIDA INFECTION
6%
TACHYCARDIA
6%
COVID-19
6%
CATARACT
6%
SJOGREN'S SYNDROME
6%
DIZZINESS
6%
DYSPHAGIA
6%
INFECTIOUS PLEURAL EFFUSION
6%
OSTEOARTHRITIS
6%
ACUTE KIDNEY INJURY
6%
NAUSEA
6%
NON-CARDIAC CHEST PAIN
6%
RHINITIS
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
OSTEOPENIA
6%
INSOMNIA
6%
PRURITUS
6%
SUPRAVENTRICULAR TACHYCARDIA
6%
SCRATCH
6%
EYE HAEMATOMA
6%
ERYTHEMA
6%
COSTOCHONDRITIS
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
ACTINIC KERATOSIS
6%
DERMATITIS ALLERGIC
6%
ASTHMA
6%
FLANK PAIN
6%
SCIATICA
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
6%
SEBORRHOEIC KERATOSIS
6%
HEPATIC STEATOSIS
6%
DRUG HYPERSENSITIVITY
6%
HERPES SIMPLEX
6%
LOCALISED INFECTION
6%
PHARYNGITIS
6%
DIABETES MELLITUS
6%
VITAMIN D DEFICIENCY
6%
BACK PAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
Period 2, Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 2, Primary Cohort: Abatacept/Upadacitinib 15 mg QD
Period 1, 30 mg Cohort: Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 1, Primary and 30 mg Cohorts: Abatacept
Period 1, Primary Cohort: Upadacitinib 15 mg QD

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~11250

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,020 Previous Clinical Trials
519,551 Total Patients Enrolled
1 Trials studying Vitiligo
185 Patients Enrolled for Vitiligo
ABBVIE INC.Study DirectorAbbVie
442 Previous Clinical Trials
160,000 Total Patients Enrolled
1 Trials studying Vitiligo
185 Patients Enrolled for Vitiligo
~360 spots leftby Feb 2027
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