Upadacitinib for Vitiligo

(Viti-Up Trial)

Not currently recruiting at 191 trial locations

Overseen By ABBVIE CALL CENTER

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Segmental vitiligo, Active skin disease, Leukotrichia, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called upadacitinib to evaluate its safety and effectiveness in treating non-segmental vitiligo (NSV), a skin condition where the immune system attacks pigment-producing cells. Participants will receive either upadacitinib or a placebo (a pill with no active drug) in the first phase, followed by upadacitinib for all in the next phase. The study will also explore combining the drug with light therapy. Individuals with a confirmed NSV diagnosis who have not responded well to treatments like topical creams might be suitable for this trial. Regular visits to a hospital or clinic for check-ups and tests are required. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new NSV treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that upadacitinib is usually well-tolerated by patients. It is already approved for treating several other immune-related conditions, suggesting general safety. However, some patients might experience serious infections, potentially leading to hospitalization or even death. This risk is known for those taking upadacitinib. Safety can vary based on individual patient characteristics, meaning some people might respond better to the treatment than others. Considering these risks is important when deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about upadacitinib for vitiligo because it offers a unique approach compared to current treatment options like topical corticosteroids and calcineurin inhibitors. Unlike these standard treatments, which primarily focus on reducing inflammation, upadacitinib is a Janus kinase (JAK) inhibitor. This means it targets specific pathways involved in the immune response, potentially offering more effective repigmentation. Additionally, upadacitinib provides an oral treatment option, which could be more convenient for patients compared to topical applications or light therapy.

What evidence suggests that upadacitinib might be an effective treatment for vitiligo?

Research has shown that upadacitinib, which participants in this trial may receive, offers promising results for treating non-segmental vitiligo (NSV), a condition that causes patches of skin to lose color. Recent studies found that upadacitinib led to significant repigmentation in many patients, meaning their skin color returned. About half of the patients noticed a reduction in the areas affected by vitiligo. Additionally, more than 43% of patients experienced major improvements in their facial skin. These findings suggest that upadacitinib could effectively manage vitiligo. ^{2 4 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with non-segmented vitiligo.

I have vitiligo that hasn't improved with certain creams or is getting worse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period A

Participants receive oral tablets of upadacitinib or placebo once a day

48 weeks

Regular visits at a hospital or clinic

Treatment Period B

All participants receive upadacitinib 15 mg once a day

112 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Optional Study 3

Participants receive upadacitinib with optional NB-UVB phototherapy

24-28 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Upadacitinib

Trial Overview 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.

How Is the Trial Designed?

Group I: Study 2, Period B: Group 2 Open-Label Extension Period Experimental Treatment 1 Intervention

Participants that were randomized to receive placebo in Period A Group 2, will receive upadacitinib 15 mg once daily for 112 weeks in Period B.

Group II: Study 2, Period B: Group 1 Open-Label Extension Period Experimental Treatment 1 Intervention

Participants that were randomized to receive upadacitinib in Period A Group 1, will continue to receive upadacitinib 15 mg once daily for 112 weeks in Period B.

Group III: Study 2, Period A: Group 1 Experimental Treatment 1 Intervention

Participants will receive upadacitinib 15 mg once daily for 48 weeks.

Group IV: Study 1, Period B: Group 2 Open-Label Extension Period Experimental Treatment 1 Intervention

Participants that were randomized to receive placebo in Period A Group 2, will receive upadacitinib 15 mg once daily for 112 weeks in Period B.

Group V: Study 1, Period B: Group 1 Open-Label Extension Period Experimental Treatment 1 Intervention

Participants that were randomized to receive upadacitinib in Period A Group 1, will continue to receive upadacitinib 15 mg once daily for 112 weeks in Period B.

Group VI: Study 1, Period A: Group 1 Experimental Treatment 1 Intervention

Participants will receive upadacitinib 15 mg once daily for 48 weeks.

Group VII: (Optional) Study 3: Experimental Treatment 2 Interventions

Participants will receive 15 mg upadacitinib once daily for 112 weeks and NB-UVB for up to 28 weeks

Group VIII: (Optional) Study 3, Period B: Open Label Upadacitinib Experimental Treatment 2 Interventions

Open Label Upadacitinib Participants will receive upadacitinib 15 mg once daily for 112 weeks

Group IX: Study 2, Period A: Group 2 Placebo Group 1 Intervention

Participants will receive placebo once daily for 48 weeks.

Group X: Study 1, Period A: Group 2 Placebo Group 1 Intervention

Participants will receive placebo once daily for 48 weeks.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

In a phase 2 study involving 157 adults with vitiligo, ruxolitinib cream demonstrated significant efficacy, with 45% of patients using the 1.5% twice daily dose achieving at least a 50% improvement in facial vitiligo area by week 24, compared to only 3% in the control group.

The treatment was well tolerated, with most adverse events being mild to moderate, suggesting that ruxolitinib cream could be a safe and effective option for repigmentation in vitiligo patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. Rosmarin, D., Pandya, AG., Lebwohl, M., et al.[2021]

The combination of apremilast and narrowband UVB therapy significantly reduces immune cell markers (like CD8+ T cells) and enhances melanogenesis markers in vitiligo skin, suggesting a more effective treatment approach than narrowband UVB alone.

This study supports the clinical observation that apremilast can enhance the repigmentation effects of narrowband UVB therapy in patients with generalized vitiligo, particularly in skin types IV-VI, although it was limited by a small sample size and high dropout rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apremilast and narrowband ultraviolet B combination therapy suppresses Th17 axis and promotes melanogenesis in vitiligo skin: a randomized, split-body, pilot study in skin types IV-VI. Kim, HJ., Del Duca, E., Pavel, AB., et al.[2023]

In two 52-week phase 3 trials, 52% of patients treated with ruxolitinib 1.5% cream experienced at least a 75% improvement in their vitiligo, demonstrating its efficacy as a treatment.

Ruxolitinib is the first FDA-approved topical medication for repigmentation in vitiligo patients, showing it is both safe and effective, although its cost may limit accessibility for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review on the Use of Topical Ruxolitinib for the Treatment of Vitiligo. Grossmann, MC., Haidari, W., Feldman, SR.[2023]

In a phase 2 trial involving patients with vitiligo, those using 1.5% ruxolitinib cream showed a significant improvement in facial Vitiligo Area Scoring Index scores, with a mean improvement of 79.9% at week 24 compared to only 1.1% in those who did not respond.

Proteomic analysis revealed distinct inflammatory biomarker profiles between patients who achieved at least a 50% improvement and those who did not, suggesting that these biomarkers could help identify which patients are more likely to benefit from ruxolitinib treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline Levels of Circulating Inflammatory Biomarkers Stratify Patients with Vitiligo Who Significantly Repigment after Treatment with Ruxolitinib Cream. Howell, MD., Kuo, FI., Rumberger, B., et al.[2023]

Combining low-dose tofacitinib with 308-nm excimer laser treatment shows promise as an effective therapy for patients with nonsegmental vitiligo who have not responded to standard treatments.

This combination therapy could offer a new option for patients struggling with vitiligo, potentially improving their skin condition when other therapies have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose tofacitinib with 308-nm excimer therapy successfully induced repigmentation in patients with refractory vitiligo. Fang, WC., Lin, SY., Huang, SM., et al.[2022]

Citations

1. news.abbvie.com news.abbvie.com/2025-10-29-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-Pivotal-Studies-Evaluating-Upadacitinib-RINVOQ-R-in-Adults-and-Adolescents-with-Vitiligo

AbbVie Announces Positive Topline Results from Phase 3 ... In two replicate Phase 3 studies, upadacitinib (RINVOQ®) achieved the co-primary endpoints of 50% reduction in Total Vitiligo Area Scoring ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06118411

NCT06118411 | A Study To Assess Adverse Events and ... This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo (NSV). ... ABT-494; Rinvoq. Participant Group ...

3. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00234-7/fulltext

a phase 2, multicentre, randomised, double-blind, placebo- ... Upadacitinib monotherapy led to substantial repigmentation of both facial and total body vitiligo lesions and may offer an effective treatment ...

4. prnewswire.com prnewswire.com/news-releases/abbvie-announces-positive-topline-results-from-phase-3-pivotal-studies-evaluating-upadacitinib-rinvoq-in-adults-and-adolescents-with-vitiligo-302597634.html

AbbVie Announces Positive Topline Results from Phase 3 ... In two replicate Phase 3 studies, upadacitinib (RINVOQ ® ) achieved the co-primary endpoints of 50% reduction in Total Vitiligo Area Scoring ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/abbvie-rinvoq-vitiligo-nsv-phase-iii-results/

AbbVie posts another win for Rinvoq in Phase III vitiligo trials Meanwhile, Rinvoq met its secondary endpoint, demonstrating a 50% clearance of facial vitiligo in 48.1% and 43.4% of patients receiving Rinvoq, ...

6. rinvoqhcp.com rinvoqhcp.com/dermatology/safety

RINVOQ® (upadacitinib) Safety Data SERIOUS INFECTIONS. Patients treated with RINVOQ are at increased risk for developing infections that may lead to hospitalization or death. · MORTALITY.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2589537024002347

Once-daily upadacitinib versus placebo in adults with ... Results from this study demonstrate that upadacitinib may represent a new treatment option for vitiligo, a condition with no approved systemic treatments and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10771099/

Upadacitinib: Mechanism of action, clinical, and translational ... Upadacitinib is generally well‐tolerated with observed differences in safety profiles likely reflective of varying patient characteristics across different ...