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Janus Kinase (JAK) Inhibitor

Upadacitinib for Vitiligo

Phase 2
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 weeks
Awards & highlights

Summary

This trial is testing upadacitinib, a medication that may help treat non-segmental vitiligo, a condition where the immune system attacks skin pigment cells. The study involves adults aged 18-65 taking the medication for several months, with some continuing for up to a year. The goal is to see if the medication is safe and effective by monitoring health changes and side effects.

Eligible Conditions
  • Vitiligo

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI)
Secondary study objectives
Change From Baseline in the Vitiligo Quality-of-Life (VitiQoL) Instrument Total Score
Percent Change From Baseline in T-VASI
Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline)
+2 more

Side effects data

From 2023 Phase 3 trial • 657 Patients • NCT03086343
24%
COVID-19
15%
URINARY TRACT INFECTION
14%
NASOPHARYNGITIS
11%
UPPER RESPIRATORY TRACT INFECTION
10%
RHEUMATOID ARTHRITIS
9%
HYPERTENSION
9%
HERPES ZOSTER
7%
BACK PAIN
6%
ALANINE AMINOTRANSFERASE INCREASED
6%
NAUSEA
6%
BRONCHITIS
6%
ASPARTATE AMINOTRANSFERASE INCREASED
6%
COUGH
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
ARTHRALGIA
5%
WEIGHT INCREASED
5%
HYPERCHOLESTEROLAEMIA
4%
HEADACHE
4%
INFLUENZA
4%
OSTEOARTHRITIS
4%
FALL
4%
DEPRESSION
4%
ANAEMIA
3%
NEUTROPENIA
3%
COVID-19 PNEUMONIA
3%
EAR INFECTION
3%
SPINAL OSTEOARTHRITIS
3%
VITAMIN D DEFICIENCY
3%
CYSTITIS
3%
RESPIRATORY TRACT INFECTION
3%
PHARYNGITIS
3%
SINUSITIS
3%
GREATER TROCHANTERIC PAIN SYNDROME
3%
DIARRHOEA
3%
VOMITING
3%
FATIGUE
3%
PYREXIA
3%
HEPATIC STEATOSIS
3%
GASTROENTERITIS
2%
ANXIETY
2%
GASTRITIS
2%
LATENT TUBERCULOSIS
2%
PNEUMONIA
2%
INSOMNIA
2%
SCIATICA
2%
DYSPEPSIA
1%
MITRAL VALVE INCOMPETENCE
1%
DERMATITIS ALLERGIC
1%
HIP FRACTURE
1%
IRON DEFICIENCY ANAEMIA
1%
BLOOD PRESSURE INCREASED
1%
CARPAL TUNNEL SYNDROME
1%
PULMONARY MASS
1%
PRURITUS
1%
CATARACT
1%
ABDOMINAL PAIN
1%
MUSCULOSKELETAL CHEST PAIN
1%
PARAESTHESIA
1%
SYNCOPE
1%
SEPTIC SHOCK
1%
PULMONARY EMBOLISM
1%
TOOTH INFECTION
1%
TOOTH FRACTURE
1%
PHARYNGITIS STREPTOCOCCAL
1%
VIRAL UPPER RESPIRATORY TRACT INFECTION
1%
ATRIAL FIBRILLATION
1%
PLEURAL EFFUSION
1%
TACHYCARDIA
1%
TINNITUS
1%
PERIPHERAL SWELLING
1%
ASYMPTOMATIC COVID-19
1%
HERPES SIMPLEX
1%
PERIODONTITIS
1%
CONTUSION
1%
BLOOD CREATININE INCREASED
1%
BLOOD TRIGLYCERIDES INCREASED
1%
HAEMOGLOBIN DECREASED
1%
HEPATIC ENZYME INCREASED
1%
LIVER FUNCTION TEST INCREASED
1%
OSTEOPENIA
1%
DIZZINESS
1%
RENAL CYST
1%
DYSPHONIA
1%
NASAL CONGESTION
1%
RHINORRHOEA
1%
COSTOCHONDRITIS
1%
MUSCLE SPASMS
1%
OSTEOPOROSIS
1%
ASTHMA
1%
DEVICE DISLOCATION
1%
TRICUSPID VALVE INCOMPETENCE
1%
GLAUCOMA
1%
CONSTIPATION
1%
CHOLELITHIASIS
1%
LOCALISED INFECTION
1%
ONYCHOMYCOSIS
1%
ORAL CANDIDIASIS
1%
DECREASED APPETITE
1%
DIABETES MELLITUS
100%
80%
60%
40%
20%
0%
Study treatment Arm
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 1, 30 mg Cohort: Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
Period 2, Primary Cohort: Abatacept/Upadacitinib 15 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

Trial Design

5Treatment groups
Experimental Treatment
Group I: Placebo Followed by Dose B of UpadacitinibExperimental Treatment2 Interventions
Participants in this group will receive placebo for 24 weeks followed by dose B of upadacitinib orally QD for 28 weeks.
Group II: Placebo Followed by Dose A of UpadacitinibExperimental Treatment2 Interventions
Participants in this group will receive placebo for 24 weeks followed by dose A of upadacitinib orally QD for 28 weeks.
Group III: Dose C of UpadacitinibExperimental Treatment1 Intervention
Participants in this group will receive dose C of upadacitinib orally QD for 52 weeks.
Group IV: Dose B of UpadacitinibExperimental Treatment1 Intervention
Participants in this group will receive dose B of upadacitinib orally QD for 52 weeks.
Group V: Dose A of UpadacitinibExperimental Treatment1 Intervention
Participants in this group will receive dose A of upadacitinib orally once daily (QD) for 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
2014
Completed Phase 3
~9710
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,004 Previous Clinical Trials
513,593 Total Patients Enrolled
1 Trials studying Vitiligo
540 Patients Enrolled for Vitiligo
ABBVIE INC.Study DirectorAbbVie
430 Previous Clinical Trials
155,913 Total Patients Enrolled
1 Trials studying Vitiligo
540 Patients Enrolled for Vitiligo
~44 spots leftby Sep 2025
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