CLINICAL TRIAL

Upadacitinib for Vitiligo

Recruiting · 18+ · All Sexes · Columbus, OH

This study is evaluating whether a drug called upadacitinib is safe and effective in people with non-segmental vitiligo.

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About the trial for Vitiligo

Eligible Conditions
Vitiligo · Non-Segmental Vitiligo

Treatment Groups

This trial involves 5 different treatments. Upadacitinib is the primary treatment being studied. Participants will be divided into 5 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Upadacitinib
DRUG
Experimental Group 2
Upadacitinib
DRUG
Experimental Group 3
Upadacitinib
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
FDA approved
Placebo
1995
Completed Phase 3
~2670

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You need to have at least 0.5 F-VASI scores and a total of 5 T-VASI scores to be considered for the study. show original
Participants who have had prior exposure to immunomodulatory biologic therapy, for any indications, but discontinued the biologic therapy prior to the first dose of study drug show original
The text states that participants must have all of the following at screening and baseline in order to be eligible for the study. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At 24 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At 24 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Upadacitinib will improve 1 primary outcome and 5 secondary outcomes in patients with Vitiligo. Measurement will happen over the course of At 24 weeks.

Percent Change From Baseline in T-VASI
AT 24 WEEKS
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100.
Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline)
AT 24 WEEKS
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.
Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline)
AT 24 WEEKS
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100.
Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI)
AT 24 WEEKS
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.
Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline)
AT 24 WEEKS
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.
Change From Baseline in the Vitiligo Quality-of-Life (VitiQoL) Instrument Total Score
AT 24 WEEKS
The VitiQoL is a validated questionnaire used in clinical trials to assess stigma-related vitiligo impacts. The VitiQoL uses subject-elicited social, affective, and behavior items, asking the subject's appraisal of the vitiligo-related impacts over the last month. Fifteen items are scored on a 7-point scale ranging from 0 ("Not at all") to 6 ("All of the time"). Item scores (0 to 6) are summed to provide a total score range of 0 to 90; higher scores indicate greater impairment of quality of life (QoL).

Patient Q & A Section

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

How many people get vitiligo a year in the United States?

Approximately 20,000 to 30,000 cases of vitiligo are new a year in the USA. These numbers will decrease as people seek care. Furthermore, the number of patients who have a family history is low. Although vitiligo is common, it is often treated as a rare disease. Effective referral schemes are essential to facilitate diagnosis.

Anonymous Patient Answer

What are common treatments for vitiligo?

For vitiligo, treatment is recommended to patients who are willing and fit for surgical debridement and/or to use a topical steroid solution. Combination therapy is strongly recommended, and the choice of which drugs to combine depends on the severity of the disease. No therapy for repainting was needed in our study.

Anonymous Patient Answer

Can vitiligo be cured?

There is a high prevalence of hypopigmented and lichenified skin in the elderly population examined. There was no improvement in a randomized controlled trial of topical minocycline as treatment.

Anonymous Patient Answer

What causes vitiligo?

The pathogenesis of vitiligo is unknown, but the presence of the HLA-DQ1 allele implies that host factors play a key role in initiating the pathogenesis of the disease.

Anonymous Patient Answer

What are the signs of vitiligo?

The two most common signs of vitiligo are the white patches and the loss of pigment in nails and hair. Since vitiligo can occur at any age, the differential diagnosis of skin lesions in children can be difficult and the diagnosis of this cutaneous disease relies heavily on clinical history and examination. Physicians should be familiar with all the known possible signs of vitiligo that may be different than the typical symptoms. These signs are summarized in the tables below\n\nAll of the above signs of vitiligo are suggestive but not definitive. They are often, but not always, seen with vitiligo.

Anonymous Patient Answer

What is vitiligo?

Vitiligo is a skin condition that affects one third to one half of the population. Its main symptom is patches of depigmented skin, but the term patchy depigmentation can also be found. While it can occur at any age, usually individuals are diagnosed in the second decade. While vitiligo can be triggered by allergies, some people are more susceptible than others. Vitiligo seems to be the result of a combination of both genetic and environmental influences.

Anonymous Patient Answer

How does upadacitinib work?

Dacitinib does not influence VEGF expression. It is postulated that it binds directly to TNF-R1, TNF-R2, and C-receptor. It is postulated that a molecule binds to a pocket in this fusion protein, where the C terminal loop of the molecule and the protein are in contact. This would not occur if a molecule that mimics these molecules bound to this pocket, thus stimulating VEGF production

Anonymous Patient Answer

Does vitiligo run in families?

Based on the small sample size, no statistically significant evidence was demonstrated that vitiligo is caused by an autosomal dominant trait. The fact that the family history was not strongly associated with the disease may suggest that other genetic predispositions play a role.

Anonymous Patient Answer

What is the average age someone gets vitiligo?

Almost all patients experience vitiligo from the age of 14 to 64, but an average time interval of 7 years between developing first symptoms and initiating treatment can be noticed. Older patients suffer from vitiligo at a higher frequency than younger patients.

Anonymous Patient Answer

What does upadacitinib usually treat?

Upadacitinib is useful in the treatment of refractory SJS/TENV cases with a high percentage of responders. It has very good adverse effects (including gastrointestinal symptoms)-the biggest hurdle in the treatment of SJS/TENV cases. There is a need for more rigorous clinical trials to confirm its benefit in the treatment of SJS/TENV cases.

Anonymous Patient Answer

Have there been other clinical trials involving upadacitinib?

The current study is the first to describe an ongoing clinical trial of upadacitinib in the treatment of progressive vitiligo. The rationale for the study, which is being conducted in the United States and Canada, is that the molecule, which is already in clinical trials for treating rheumatoid arthritis, may represent a promising treatment for vitiligo. Patients taking upadacitinib will be randomised to treatment with the medicine or a placebo, and follow-up evaluations of the drug will be conducted by investigators from a variety of disciplines, including dermatologists, rheumatologists and clinicians involved with vitiligo.

Anonymous Patient Answer
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