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CompletedNCT04927975Updated Oct 8, 2024Results posted

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 interventional study of Upadacitinib and Placebo in Non-Segmental Vitiligo, sponsored by AbbVie. Completed at 35 sites in 4 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by AbbVie · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
185
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.

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.

02

Conditions studied

  • Non-Segmental Vitiligo

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Keywords

  • Vitiligo
  • Non-segmental vitiligo (NSV)
  • Upadacitinib
  • ABT-494
  • RINVOQ
03

In context

Vitiligo

298 studies on the registry are indexed under Vitiligo; 69 are open to participants now.

This study's enrollment of 185 is above the median of 30 across 227 interventional studies indexed under Vitiligo.

Browse Vitiligo studies →

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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;
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
185 participants (actual)

Study arms

  • Experimental
    Upa 22 mg Period 1, then Upa 22 mg Period 2

    Participants 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.

    Drug: Upadacitinib

  • Experimental
    Upa 11 mg Period 1, then Upa 11 mg Period 2

    Participants 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.

    Drug: Upadacitinib

  • Experimental
    Upa 6 mg Period 1, then Upa 6 mg Period 2

    Participants 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.

    Drug: Upadacitinib

  • Experimental
    Placebo Period 1, then Upa 22 mg Period 2

    Participants 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.

    Drug: Upadacitinib · Drug: Placebo

  • Experimental
    Placebo Period 1, then Upa 11 mg Period 2

    Participants 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.

    Drug: Upadacitinib · Drug: Placebo

Interventions

  • DrugUpadacitinib

    Oral tablets

    Also known as: ABT-494, RINVOQ

  • DrugPlacebo

    Oral tablets

06

What researchers measure

Primary outcomes

  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.

    Time frame: Baseline, Week 24

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline, Week 24

07

Results

Posted Oct 8, 2024

Participant flow

Period 1 (Baseline-Week 24)
Participant flow — Period 1 (Baseline-Week 24)
MilestonePlacebo Period 1Placebo Period 1, Then Upa 11 mg Period 2Placebo Period 1, Then Upa 22 mg Period 2Upa 6 mg Period 1, Then Upa 6 mg Period 2Upa 11 mg Period 1, Then Upa 11 mg Period 2Upa 22 mg Period 1, Then Upa 22 mg Period 2
Started4600494743
Completed4400464538
Not completed200325
Withdrew: Withdrawal by subject200114
Withdrew: Lost to follow-up000210
Withdrew: Death000001
Period 2 (Week 24-52)
Participant flow — Period 2 (Week 24-52)
MilestonePlacebo Period 1Placebo Period 1, Then Upa 11 mg Period 2Placebo Period 1, Then Upa 22 mg Period 2Upa 6 mg Period 1, Then Upa 6 mg Period 2Upa 11 mg Period 1, Then Upa 11 mg Period 2Upa 22 mg Period 1, Then Upa 22 mg Period 2
Started02122454533
Completed01921393830
Not completed021673
Withdrew: Lost to follow-up010262
Withdrew: Withdrawal by subject011411

Outcome measures

PrimaryPercent 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.

Time frame:
Baseline, Week 24
Reported as:
Least squares mean · Percent change from baseline
Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24
Percent change from baselinePlacebo Period 1Upa 6 mg Period 1, Then Upa 6 mg Period 2Upa 11 mg Period 1, Then Upa 11 mg Period 2Upa 22 mg Period 1, Then Upa 22 mg Period 2
Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24-14.36 (-24.86 to -3.85)-21.96 (-32.18 to -11.75)-35.63 (-46.11 to -25.14)-33.96 (-45.41 to -22.50)
Statistical analysis
  • Placebo Period 1 vs Upa 6 mg Period 1, Then Upa 6 mg Period 2 · Mixed-Effect Model Repeat Measurement · p = 0.304 · Ls mean difference: -7.60 · 95% CI -22.18 to 6.97
  • Placebo Period 1 vs Upa 11 mg Period 1, Then Upa 11 mg Period 2 · Mixed-Effect Model Repeat Measurement · p = 0.005 · Ls mean difference: -21.27 · 95% CI -36.02 to -6.52
  • Placebo Period 1 vs Upa 22 mg Period 1, Then Upa 22 mg Period 2 · Mixed-Effect Model Repeat Measurement · p = 0.013 · Ls mean difference: -19.60 · 95% CI -35.04 to -4.16
SecondaryPercentage 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.

Time frame:
Baseline, Week 24
Reported as:
Number · percentage of participants
Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline) at Week 24
percentage of participantsPlacebo Period 1Upa 6 mg Period 1, Then Upa 6 mg Period 2Upa 11 mg Period 1, Then Upa 11 mg Period 2Upa 22 mg Period 1, Then Upa 22 mg Period 2
Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline) at Week 242.2 (0.0 to 6.4)8.2 (0.5 to 15.8)19.1 (7.9 to 30.4)14.0 (3.6 to 24.3)
Statistical analysis
  • Placebo Period 1 vs Upa 6 mg Period 1, Then Upa 6 mg Period 2 · Cochran-Mantel-Haenszel · p = 0.100 · Response rate difference: 6.9 · 95% CI -1.3 to 15.2
  • Placebo Period 1 vs Upa 11 mg Period 1, Then Upa 11 mg Period 2 · Cochran-Mantel-Haenszel · p = 0.002 · Response rate difference: 17.8 · 95% CI 6.5 to 29.0
  • Placebo Period 1 vs Upa 22 mg Period 1, Then Upa 22 mg Period 2 · Cochran-Mantel-Haenszel · p = 0.026 · Response rate difference: 11.7 · 95% CI 1.4 to 21.9
SecondaryPercentage 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.

Time frame:
Baseline, Week 24
Reported as:
Number · percentage of participants
Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline) at Week 24
percentage of participantsPlacebo Period 1Upa 6 mg Period 1, Then Upa 6 mg Period 2Upa 11 mg Period 1, Then Upa 11 mg Period 2Upa 22 mg Period 1, Then Upa 22 mg Period 2
Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline) at Week 2410.9 (1.9 to 19.9)16.3 (6.0 to 26.7)38.3 (24.4 to 52.2)39.5 (24.9 to 54.1)
Statistical analysis
  • Placebo Period 1 vs Upa 6 mg Period 1, Then Upa 6 mg Period 2 · Cochran-Mantel-Haenszel · p = 0.327 · Response rate difference: 6.6 · 95% CI -6.6 to 19.7
  • Placebo Period 1 vs Upa 11 mg Period 1, Then Upa 11 mg Period 2 · Cochran-Mantel-Haenszel · p = <0.001 · Response rate difference: 29.3 · 95% CI 13.8 to 44.9
  • Placebo Period 1 vs Upa 22 mg Period 1, Then Upa 22 mg Period 2 · Cochran-Mantel-Haenszel · p = <0.001 · Response rate difference: 28.7 · 95% CI 12.6 to 44.7
SecondaryPercentage 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.

Time frame:
Baseline, Week 24
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline) at Week 24
percentage of participantsPlacebo Period 1Upa 6 mg Period 1, Then Upa 6 mg Period 2Upa 11 mg Period 1, Then Upa 11 mg Period 2Upa 22 mg Period 1, Then Upa 22 mg Period 2
Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline) at Week 242.2 (0.0 to 6.4)6.1 (0.0 to 12.8)6.4 (0.0 to 13.4)11.6 (2.0 to 21.2)
Statistical analysis
  • Placebo Period 1 vs Upa 6 mg Period 1, Then Upa 6 mg Period 2 · Cochran-Mantel-Haenszel · p = 0.340 · Response rate difference: 3.7 · 95% CI -3.9 to 11.2
  • Placebo Period 1 vs Upa 11 mg Period 1, Then Upa 11 mg Period 2 · Cochran-Mantel-Haenszel · p = 0.358 · Response rate difference: 3.8 · 95% CI -4.3 to 11.8
  • Placebo Period 1 vs Upa 22 mg Period 1, Then Upa 22 mg Period 2 · Cochran-Mantel-Haenszel · p = 0.027 · Response rate difference: 9.1 · 95% CI 1.0 to 17.2
SecondaryPercent 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.

Time frame:
Baseline, Week 24
Reported as:
Least squares mean · Percent change from baseline
Percent Change From Baseline in T-VASI at Week 24
Percent change from baselinePlacebo Period 1Upa 6 mg Period 1, Then Upa 6 mg Period 2Upa 11 mg Period 1, Then Upa 11 mg Period 2Upa 22 mg Period 1, Then Upa 22 mg Period 2
Percent Change From Baseline in T-VASI at Week 24-6.42 (-13.17 to 0.34)-13.87 (-20.45 to -7.29)-17.26 (-24.00 to -10.52)-20.69 (-28.05 to -13.32)
Statistical analysis
  • Placebo Period 1 vs Upa 6 mg Period 1, Then Upa 6 mg Period 2 · Mixed-Effect Model Repeat Measurement · p = 0.120 · Ls mean difference: -7.45 · 95% CI -16.86 to 1.96
  • Placebo Period 1 vs Upa 11 mg Period 1, Then Upa 11 mg Period 2 · Mixed-Effect Model Repeat Measurement · p = 0.026 · Ls mean difference: -10.84 · 95% CI -20.37 to -1.32
  • Placebo Period 1 vs Upa 22 mg Period 1, Then Upa 22 mg Period 2 · Mixed-Effect Model Repeat Measurement · p = 0.005 · Ls mean difference: -14.27 · 95% CI -24.24 to -4.30
SecondaryChange 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.

Time frame:
Baseline, Week 24
Reported as:
Least squares mean · units on a scale
Change From Baseline in the Vitiligo Quality-of-Life (VitiQoL) Instrument Total Score at Week 24
units on a scalePlacebo Period 1Upa 6 mg Period 1, Then Upa 6 mg Period 2Upa 11 mg Period 1, Then Upa 11 mg Period 2Upa 22 mg Period 1, Then Upa 22 mg Period 2
Change From Baseline in the Vitiligo Quality-of-Life (VitiQoL) Instrument Total Score at Week 24-5.5 (-10.3 to -0.8)-7.5 (-12.0 to -3.0)-3.7 (-8.2 to 0.9)-6.6 (-11.6 to -1.6)
Statistical analysis
  • Placebo Period 1 vs Upa 6 mg Period 1, Then Upa 6 mg Period 2 · Mixed-Effect Model Repeat Measurement · p = 0.545 · Ls mean difference: -1.9 · 95% CI -8.3 to 4.4
  • Placebo Period 1 vs Upa 11 mg Period 1, Then Upa 11 mg Period 2 · Mixed-Effect Model Repeat Measurement · p = 0.565 · Ls mean difference: 1.9 · 95% CI -4.5 to 8.3
  • Placebo Period 1 vs Upa 22 mg Period 1, Then Upa 22 mg Period 2 · Mixed-Effect Model Repeat Measurement · p = 0.754 · Ls mean difference: -1.1 · 95% CI -7.8 to 5.6

Adverse events

Collected over All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo Period 10/46 (0%)1/46 (2.2%)26/46 (56.5%)
Upa 6 mg Period 10/49 (0%)1/49 (2%)19/49 (38.8%)
Upa 11 mg Period 10/47 (0%)0/47 (0%)28/47 (59.6%)
Upa 22 mg Period 11/43 (2.3%)3/43 (7%)23/43 (53.5%)
Placebo Period 1, Then Upa 11 mg Period 20/21 (0%)1/21 (4.8%)9/21 (42.9%)
Placebo Period 1, Then Upa 22 mg Period 20/22 (0%)0/22 (0%)11/22 (50%)
Upa 6 mg Period 1, Then Upa 6 mg Period 20/45 (0%)0/45 (0%)12/45 (26.7%)
Upa 11 mg Period 1, Then Upa 11 mg Period 20/45 (0%)2/45 (4.4%)22/45 (48.9%)
Upa 22 mg Period 1, Then Upa 22 mg Period 20/33 (0%)0/33 (0%)17/33 (51.5%)
Most frequent serious events
Most frequent serious events
EventPlacebo Period 1Upa 6 mg Period 1Upa 11 mg Period 1Upa 22 mg Period 1Placebo Period 1, Then Upa 11 mg Period 2Placebo Period 1, Then Upa 22 mg Period 2Upa 6 mg Period 1, Then Upa 6 mg Period 2Upa 11 mg Period 1, Then Upa 11 mg Period 2Upa 22 mg Period 1, Then Upa 22 mg Period 2
CLAVICLE FRACTUREInjury, poisoning and procedural complications0/460/490/470/431/210/220/450/450/33
DEATHGeneral disorders0/460/490/471/430/210/220/450/450/33
PAINGeneral disorders0/460/490/471/430/210/220/450/450/33
COVID-19 PNEUMONIAInfections and infestations0/460/490/471/430/210/220/450/450/33
INVASIVE LOBULAR BREAST CARCINOMANeoplasms benign, malignant and unspecified (incl cysts and polyps)0/460/490/470/430/210/220/451/450/33
ISCHAEMIC STROKENervous system disorders0/460/490/470/430/210/220/451/450/33
NEPHROLITHIASISRenal and urinary disorders1/460/490/470/430/210/220/450/450/33
ARTERIOSCLEROSIS CORONARY ARTERYCardiac disorders0/461/490/470/430/210/220/450/450/33
Most frequent other events
Showing 10 of 20
Most frequent other events
EventPlacebo Period 1Upa 6 mg Period 1Upa 11 mg Period 1Upa 22 mg Period 1Placebo Period 1, Then Upa 11 mg Period 2Placebo Period 1, Then Upa 22 mg Period 2Upa 6 mg Period 1, Then Upa 6 mg Period 2Upa 11 mg Period 1, Then Upa 11 mg Period 2Upa 22 mg Period 1, Then Upa 22 mg Period 2
COVID-19Infections and infestations8/467/499/479/431/215/227/4512/455/33
HEADACHENervous system disorders4/460/499/472/432/211/222/455/452/33
NASOPHARYNGITISInfections and infestations3/464/492/474/433/213/221/452/452/33
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations1/463/492/470/433/210/221/454/453/33
ACNESkin and subcutaneous tissue disorders1/463/494/476/431/212/221/452/453/33
URINARY TRACT INFECTIONInfections and infestations3/461/494/472/430/213/222/451/450/33
FATIGUEGeneral disorders1/462/492/475/431/210/222/450/450/33
SKIN LACERATIONInjury, poisoning and procedural complications0/460/490/470/432/210/220/450/450/33
NAUSEAGastrointestinal disorders3/460/492/474/430/210/220/451/450/33
ABDOMINAL PAIN UPPERGastrointestinal disorders4/460/490/470/430/210/220/450/450/33

Baseline characteristics

ITT Population in Period 1 (ITT_1): all randomized participants in Period 1, analyzed according to the treatment groups that they were randomized to.

Age, Continuous
Age, Continuous(years)Placebo Period 1Upa 6 mg Period 1, Then Upa 6 mg Period 2Upa 11 mg Period 1, Then Upa 11 mg Period 2Upa 22 mg Period 1, Then Upa 22 mg Period 2Total
Mean46.8 ± 10.4845.1 ± 11.6845.5 ± 11.9048.2 ± 11.1346.3 ± 11.30
Sex: Female, Male
Sex: Female, Male(Participants)Placebo Period 1Upa 6 mg Period 1, Then Upa 6 mg Period 2Upa 11 mg Period 1, Then Upa 11 mg Period 2Upa 22 mg Period 1, Then Upa 22 mg Period 2Total
Female29263426115
Male1723131770
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo Period 1Upa 6 mg Period 1, Then Upa 6 mg Period 2Upa 11 mg Period 1, Then Upa 11 mg Period 2Upa 22 mg Period 1, Then Upa 22 mg Period 2Total
Hispanic or Latino564520
Not Hispanic or Latino41434338165
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo Period 1Upa 6 mg Period 1, Then Upa 6 mg Period 2Upa 11 mg Period 1, Then Upa 11 mg Period 2Upa 22 mg Period 1, Then Upa 22 mg Period 2Total
American Indian or Alaska Native00011
Asian667625
Native Hawaiian or Other Pacific Islander01001
Black or African American433111
White34353633138
More than one race03115
Unknown or Not Reported21014
Total Vitiligo Area Scoring Index (T-VASI)
Total Vitiligo Area Scoring Index (T-VASI)(units on a scale)Placebo Period 1Upa 6 mg Period 1, Then Upa 6 mg Period 2Upa 11 mg Period 1, Then Upa 11 mg Period 2Upa 22 mg Period 1, Then Upa 22 mg Period 2Total
Mean21.014 ± 16.951620.993 ± 15.967222.322 ± 18.178421.843 ± 15.932421.534 ± 16.6634
Facial Vitiligo Area Scoring Index (F-VASI)
Facial Vitiligo Area Scoring Index (F-VASI)(units on a scale)Placebo Period 1Upa 6 mg Period 1, Then Upa 6 mg Period 2Upa 11 mg Period 1, Then Upa 11 mg Period 2Upa 22 mg Period 1, Then Upa 22 mg Period 2Total
Mean1.043 ± 0.60941.154 ± 0.76551.021 ± 0.57811.159 ± 0.65851.094 ± 0.6559
08

Study locations

35 sites
  • University of California Irvine /ID# 229390
    Irvine, California 92697-1385, United States
  • Stanford University /ID# 228000
    Redwood City, California 94063, United States
  • Clearlyderm Dermatology /ID# 227993
    Boca Raton, Florida 33428, United States
  • New Horizon Research Center /ID# 229403
    Miami, Florida 33165-3372, United States
  • Park Avenue Dermatology, PA /ID# 229400
    Orange Park, Florida 32073, United States
  • ForCare Clinical Research /ID# 228010
    Tampa, Florida 33613-1244, United States
  • Dawes Fretzin, LLC /ID# 227996
    Indianapolis, Indiana 46256, United States
  • Tufts Medical Center /ID# 228087
    Boston, Massachusetts 02111-1552, United States
  • Duplicate_UMass Chan Medical School /ID# 228066
    Worcester, Massachusetts 01655, United States
  • Duplicate_Michigan Center for Research Company /ID# 228054
    Clarkston, Michigan 48346, United States
  • Hamzavi Dermatology /ID# 228056
    Fort Gratiot, Michigan 48059, United States
  • Remington-Davis Clinical Research /ID# 229401
    Columbus, Ohio 43215, United States
  • Essential Medical Research, LLC /ID# 228074
    Tulsa, Oklahoma 74137-2842, United States
  • Oregon Dermatology and Research Center /ID# 228007
    Portland, Oregon 97210, United States
  • Oregon Medical Research Center /ID# 228073
    Portland, Oregon 97223, United States
  • Duplicate_Medical University of South Carolina /ID# 228067
    Charleston, South Carolina 29425, United States
  • International Clinical Research - Tennessee LLC /ID# 228059
    Murfreesboro, Tennessee 37130-2450, United States
  • Bellaire Dermatology Associates /ID# 228004
    Bellaire, Texas 77401, United States
  • University of Texas Health Science Center at Houston /ID# 229399
    Houston, Texas 77030-1501, United States
  • Virginia Clinical Research, Inc. /ID# 228050
    Norfolk, Virginia 23502, United States
  • Dr. Chih-ho Hong Medical Inc. /ID# 228403
    Surrey, British Columbia V3R 6A7, Canada
  • Wiseman Dermatology Research /ID# 228410
    Winnipeg, Manitoba R3M 3Z4, Canada
  • Research Toronto /ID# 228401
    Toronto, Ontario M4W 2N4, Canada
  • Duplicate_K. Papp Clinical Research /ID# 228877
    Waterloo, Ontario N2J 1C4, Canada
  • Centre de Recherche dermatologique du Quebec Metropolitain /ID# 228388
    Québec, Quebec G1V 4X7, Canada
  • Chu de Nice-Hopital Larchet Ii /Id# 228192
    Nice, Alpes-Maritimes 06200, France
  • Duplicate_Hopital Saint-Andre /ID# 228193
    Bordeaux, Gironde 33075, France
  • HCL - Hopital Edouard Herriot /ID# 228194
    Lyon, Rhone 69003, France
  • Duplicate_Hopital Henri Mondor /ID# 228198
    Creteil, 94000, France
  • CHU Toulouse - Hopital Larrey /ID# 228196
    Toulouse, 31400, France
  • Nagoya City University Hospital /ID# 228725
    Nagoya shi, Aichi 467-8602, Japan
  • Nippon Medical School Hospital /ID# 230361
    Bunkyo-ku, Tokyo 113-8602, Japan
  • Tokyo Medical University Hospital /ID# 230288
    Shinjuku-ku, Tokyo 160-0023, Japan
  • Yamagata University Hospital /ID# 230362
    Yamagata-shi, Yamagata 990-9585, Japan
  • Yamanashi Prefectural Central Hospital /ID# 229441
    Kofu-shi, Yamanashi 400-8506, Japan
09

References and documents

Study documents

  • Study protocol · Jul 7, 2021
  • Statistical analysis plan · Dec 27, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04927975
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Jun 16, 2021
Start date
Jun 30, 2021
Primary completion
Jan 13, 2023
Completion
Aug 29, 2023
Results posted
Oct 8, 2024
Last update
Oct 8, 2024

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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