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Non-Segmental VitiligoPhase 2NCT04927975

Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo

A Phase 2 study testing Upadacitinib in people with Non-Segmental Vitiligo, run by AbbVie at 35 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo. Adverse effects and change in disease activity will be assessed. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Non-Segmental Vitiligo
What is being tested?
Upadacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
185 participants
Where
35 sitesin 4 countries
Study dates
30 Jun 2021to 29 Aug 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of non-segmental vitiligo (NSV) and no segmental or localized vitiligo.
  • Participants with all of the following at Screening and Baseline.
  • Visits: ≥ 0.5 F-VASI and ≥ 5 total vitiligo area scoring index (T-VASI).
  • 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. Recommended washout periods for biologic therapies include ≥ 4 weeks for etanercept; ≥ 8 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and ixekizumab; ≥ 16 weeks for secukinumab; and ≥ 12 weeks for ustekinumab. For biologic therapies not specified, therapies must be discontinued at least 5 times the mean terminal elimination half-life of a drug or 3 months prior to Baseline, whichever is longer.

Who cannot join

  • Participants with segmental or localized vitiligo.
  • Participants with other skin conditions that would interfere with evaluation of vitiligo, participants with uncontrolled thyroid disease, and participants with > 33% leukotrichia on the face or > 33% leukotrichia on the body (including face).
  • Participants previously treated with any topical or systemic janus kinase (JAK) inhibitor or permanent skin bleaching agents.
  • Participants treated with any systemic vitiligo therapy (e.g., methotrexate, mycophenolate mofetil, corticosteroids), supplemental vitiligo therapy (antioxidants/vitamins/herbal medicine/traditional Chinese medicine), and/or topical vitiligo therapy including permanent or temporary tattoos within a minimum of 30 days prior to the first dose of study drug (Note: Camouflage and makeup may be used).
  • Participants treated with any phototherapy, including excimer (or other forms of laser therapy), within a minimum of 12 weeks prior to the first dose of study drug.
  • Participants have history of malignancy other than successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.
Show all 11Show fewer
  • Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery;
  • History of an organ transplant which requires continued immunosuppression;
  • History of gastrointestinal (GI) perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment;
  • Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; subjects with a history of gastric banding/segmentation are not excluded;
  • Uncontrolled thyroid disease;

Trial locations and contacts

35 sites in 4 countries.

35 sites in 4 countries

United States20 sites

  • Bellaire Dermatology Associates /ID# 228004

    Bellaire, Texas, 77401

  • Clearlyderm Dermatology /ID# 227993

    Boca Raton, Florida, 33428

  • Tufts Medical Center /ID# 228087

    Boston, Massachusetts, 02111-1552

  • Duplicate_Medical University of South Carolina /ID# 228067

    Charleston, South Carolina, 29425

  • Duplicate_Michigan Center for Research Company /ID# 228054

    Clarkston, Michigan, 48346

  • Remington-Davis Clinical Research /ID# 229401

    Columbus, Ohio, 43215

  • Hamzavi Dermatology /ID# 228056

    Fort Gratiot, Michigan, 48059

  • University of Texas Health Science Center at Houston /ID# 229399

    Houston, Texas, 77030-1501

  • Dawes Fretzin, LLC /ID# 227996

    Indianapolis, Indiana, 46256

  • University of California Irvine /ID# 229390

    Irvine, California, 92697-1385

  • New Horizon Research Center /ID# 229403

    Miami, Florida, 33165-3372

  • International Clinical Research - Tennessee LLC /ID# 228059

    Murfreesboro, Tennessee, 37130-2450

  • Virginia Clinical Research, Inc. /ID# 228050

    Norfolk, Virginia, 23502

  • Park Avenue Dermatology, PA /ID# 229400

    Orange Park, Florida, 32073

  • Oregon Dermatology and Research Center /ID# 228007

    Portland, Oregon, 97210

  • Oregon Medical Research Center /ID# 228073

    Portland, Oregon, 97223

  • Stanford University /ID# 228000

    Redwood City, California, 94063

  • ForCare Clinical Research /ID# 228010

    Tampa, Florida, 33613-1244

  • Essential Medical Research, LLC /ID# 228074

    Tulsa, Oklahoma, 74137-2842

  • Duplicate_UMass Chan Medical School /ID# 228066

    Worcester, Massachusetts, 01655

Other trials in United States

Canada5 sites

  • Centre de Recherche dermatologique du Quebec Metropolitain /ID# 228388

    Québec, Quebec, G1V 4X7

  • Dr. Chih-ho Hong Medical Inc. /ID# 228403

    Surrey, British Columbia, V3R 6A7

  • Research Toronto /ID# 228401

    Toronto, Ontario, M4W 2N4

  • Duplicate_K. Papp Clinical Research /ID# 228877

    Waterloo, Ontario, N2J 1C4

  • Wiseman Dermatology Research /ID# 228410

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

France5 sites

  • Duplicate_Hopital Saint-Andre /ID# 228193

    Bordeaux, Gironde, 33075

  • Duplicate_Hopital Henri Mondor /ID# 228198

    Créteil, 94000

  • HCL - Hopital Edouard Herriot /ID# 228194

    Lyon, Rhone, 69003

  • Chu de Nice-Hopital Larchet Ii /Id# 228192

    Nice, Alpes-Maritimes, 06200

  • CHU Toulouse - Hopital Larrey /ID# 228196

    Toulouse, 31400

Other trials in France

Japan5 sites

  • Nippon Medical School Hospital /ID# 230361

    Bunkyo-ku, Tokyo, 113-8602

  • Yamanashi Prefectural Central Hospital /ID# 229441

    Kofu, Yamanashi, 400-8506

  • Nagoya City University Hospital /ID# 228725

    Nagoya, Aichi-ken, 467-8602

  • Tokyo Medical University Hospital /ID# 230288

    Shinjuku-ku, Tokyo, 160-0023

  • Yamagata University Hospital /ID# 230362

    Yamagata, Yamagata, 990-9585

Other trials in Japan

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Non-Segmental Vitiligo

Vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo. Adverse effects and change in disease activity will be assessed.

Upadacitinib is being evaluated for the treatment of non-segmental vitiligo. The study will enroll approximately 160 participants aged 18-65 with non-segmental vitiligo in 5 treatment arms across 35 sites worldwide.

Read more

Participants will either receive study drug vs placebo oral tablets once daily (QD) for 24 weeks (Period A). In Period B (up to 52 weeks), participants who received placebo during the first 24 weeks will switch to study drug. Participants who received study drug during the first 24 weeks, will continue to receive study drug.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Being tested
Upadacitinib, Placebo
Keywords
Vitiligo, Non-segmental vitiligo (NSV), Upadacitinib, ABT-494, RINVOQ
Medical subject headings
Vitiligo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UpadacitinibDrug

    Also called ABT-494, RINVOQ

    Oral tablets

  • PlaceboDrug

    Oral tablets

Study groups in NCT04927975
Study groupRoleWhat they receive
Upa 22 mg Period 1, then Upa 22 mg Period 2ExperimentalParticipants received upadacitinib 22 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
Receives: Drug: Upadacitinib
Upa 11 mg Period 1, then Upa 11 mg Period 2ExperimentalParticipants received upadacitinib 11 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
Receives: Drug: Upadacitinib
Upa 6 mg Period 1, then Upa 6 mg Period 2ExperimentalParticipants received upadacitinib 6 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 6 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
Receives: Drug: Upadacitinib
Placebo Period 1, then Upa 22 mg Period 2ExperimentalParticipants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
Receives: Drug: Upadacitinib; Drug: Placebo
Placebo Period 1, then Upa 11 mg Period 2ExperimentalParticipants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
Receives: Drug: Upadacitinib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24

    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, with higher scores indicating more severe disease. Negative changes from baseline indicate improvement.

    Measured: Baseline, Week 24

Secondary outcomes (5)

  1. Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline) at Week 24

    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, with higher scores indicating more severe disease.

    Measured: Baseline, Week 24

  2. Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline) at Week 24

    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, with higher scores indicating more severe disease.

    Measured: Baseline, Week 24

  3. Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline) at Week 24

    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, with higher scores indicating more severe disease.

    Measured: Baseline, Week 24

  4. Percent Change From Baseline in T-VASI at Week 24

    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, with higher scores indicating more severe disease. Negative changes from baseline indicate improvement.

    Measured: Baseline, Week 24

  5. Change From Baseline in the Vitiligo Quality-of-Life (VitiQoL) Instrument Total Score at Week 24

    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). Negative changes from baseline indicate improvement.

    Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2021
  2. Study start30 Jun 2021
  3. Primary completion13 Jan 2023
  4. Study completion29 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04927975
Sponsor's protocol ID
M19-051
Other IDs
2021-000081-15
Status last verified
Sep 2024
First submitted
11 Jun 2021
Last updated
8 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

  • Ezzedine K, Soliman AM, Camp HS, Ladd MK, Pokrzywinski R, Coyne KS, Sen R, Schlosser BJ, Bae JM, Hamzavi I. Psychometric Properties and Meaningful Change Thresholds of the Vitiligo Area Scoring Index. JAMA Dermatol. 2025 Jan 1;161(1):39-46. doi: 10.1001/jamadermatol.2024.4534.

    PubMed 39475960

  • Passeron T, Ezzedine K, Hamzavi I, van Geel N, Schlosser BJ, Wu X, Huang X, Soliman AM, Rosmarin D, Harris JE, Camp HS, Pandya AG. Once-daily upadacitinib versus placebo in adults with extensive non-segmental vitiligo: a phase 2, multicentre, randomised, double-blind, placebo-controlled, dose-ranging study. EClinicalMedicine. 2024 May 31;73:102655. doi: 10.1016/j.eclinm.2024.102655. eCollection 2024 Jul.

    PubMed 38873632

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Upadacitinib in people with Non-Segmental Vitiligo, run by AbbVie at 35 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Canada, France, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04927975, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.

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