Trial · NCT04927975
Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo
NCT04927975, Phase 2, Completed, AbbVie; results first posted 2024-10-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo. Trials, record NCT04927975. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04927975
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo
- NCT number
- NCT04927975
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 185 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Non-Segmental Vitiligo
- Interventions
- Upadacitinib, Placebo
- First posted
- 2021-06-16
- Last updated
- 2024-10-08
- Other registries' IDs
- eudract:2021-000081-15
- Results first posted
- 2024-10-08
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 | Baseline, 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. |
| Secondary | Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline) at Week 24 | Baseline, 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. |
| Secondary | Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline) at Week 24 | Baseline, 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. |
| Secondary | Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline) at Week 24 | Baseline, 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. |
| Secondary | Percent Change From Baseline in T-VASI at Week 24 | Baseline, 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. |
| Secondary | Change From Baseline in the Vitiligo Quality-of-Life (VitiQoL) Instrument Total Score at Week 24 | Baseline, 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 | Baseline, Week 24 | ITT\_1: all randomized participants in Period 1, analyzed according to the treatment groups that they were randomized to; mixed model repeated measures analysis (MMRM) including observed measurements at all visits | Percent change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline) at Week 24 | Baseline, Week 24 | ITT\_1: all randomized participants in Period 1, analyzed according to the treatment groups that they were randomized to; NRI-MI (non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random) | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline) at Week 24 | Baseline, Week 24 | ITT\_1: all randomized participants in Period 1, analyzed according to the treatment groups that they were randomized to; NRI-MI (non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random) | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline) at Week 24 | Baseline, Week 24 | ITT\_1: all randomized participants in Period 1, analyzed according to the treatment groups that they were randomized to; NRI-MI (non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random) | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in T-VASI at Week 24 | Baseline, Week 24 | ITT\_1: all randomized participants in Period 1, analyzed according to the treatment groups that they were randomized to; mixed model repeated measures analysis (MMRM) including observed measurements at all visits. | Percent change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Vitiligo Quality-of-Life (VitiQoL) Instrument Total Score at Week 24 | Baseline, Week 24 | ITT\_1: all randomized participants in Period 1, analyzed according to the treatment groups that they were randomized to; mixed model repeated measures analysis (MMRM) including observed measurements at all visits. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 | Placebo Period 1 | -14.36 | 95% Confidence Interval -24.86 to -3.85 | Percent change from baseline | |
| Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 | Upa 6 mg Period 1, Then Upa 6 mg Period 2 | -21.96 | 95% Confidence Interval -32.18 to -11.75 | Percent change from baseline | |
| Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 | Upa 11 mg Period 1, Then Upa 11 mg Period 2 | -35.63 | 95% Confidence Interval -46.11 to -25.14 | Percent change from baseline | |
| Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 | Upa 22 mg Period 1, Then Upa 22 mg Period 2 | -33.96 | 95% Confidence Interval -45.41 to -22.50 | Percent change from baseline | |
| Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline) at Week 24 | Placebo Period 1 | 2.2 | 95% Confidence Interval 0.0 to 6.4 | percentage of participants | |
| Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline) at Week 24 | Upa 6 mg Period 1, Then Upa 6 mg Period 2 | 8.2 | 95% Confidence Interval 0.5 to 15.8 | percentage of participants | |
| Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline) at Week 24 | Upa 11 mg Period 1, Then Upa 11 mg Period 2 | 19.1 | 95% Confidence Interval 7.9 to 30.4 | percentage of participants | |
| Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline) at Week 24 | Upa 22 mg Period 1, Then Upa 22 mg Period 2 | 14.0 | 95% Confidence Interval 3.6 to 24.3 | percentage of participants | |
| Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline) at Week 24 | Placebo Period 1 | 10.9 | 95% Confidence Interval 1.9 to 19.9 | percentage of participants | |
| Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline) at Week 24 | Upa 6 mg Period 1, Then Upa 6 mg Period 2 | 16.3 | 95% Confidence Interval 6.0 to 26.7 | percentage of participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (Baseline-Week 24) | STARTED | Placebo Period 1 | 46 | |
| Period 1 (Baseline-Week 24) | STARTED | Placebo Period 1, Then Upa 11 mg Period 2 | 0 | |
| Period 1 (Baseline-Week 24) | STARTED | Placebo Period 1, Then Upa 22 mg Period 2 | 0 | |
| Period 1 (Baseline-Week 24) | STARTED | Upa 6 mg Period 1, Then Upa 6 mg Period 2 | 49 | |
| Period 1 (Baseline-Week 24) | STARTED | Upa 11 mg Period 1, Then Upa 11 mg Period 2 | 47 | |
| Period 1 (Baseline-Week 24) | STARTED | Upa 22 mg Period 1, Then Upa 22 mg Period 2 | 43 | |
| Period 1 (Baseline-Week 24) | COMPLETED | Placebo Period 1 | 44 | |
| Period 1 (Baseline-Week 24) | COMPLETED | Placebo Period 1, Then Upa 11 mg Period 2 | 0 | |
| Period 1 (Baseline-Week 24) | COMPLETED | Placebo Period 1, Then Upa 22 mg Period 2 | 0 | |
| Period 1 (Baseline-Week 24) | COMPLETED | Upa 6 mg Period 1, Then Upa 6 mg Period 2 | 46 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events252
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Placebo Period 1 | 4 | 46 | 5 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Upa 6 mg Period 1 | 0 | 49 | 0 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Upa 11 mg Period 1 | 0 | 47 | 0 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Upa 22 mg Period 1 | 0 | 43 | 0 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Placebo Period 1, Then Upa 11 mg Period 2 | 0 | 21 | 0 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Placebo Period 1, Then Upa 22 mg Period 2 | 0 | 22 | 0 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Upa 6 mg Period 1, Then Upa 6 mg Period 2 | 0 | 45 | 0 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Upa 11 mg Period 1, Then Upa 11 mg Period 2 | 0 | 45 | 0 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Upa 22 mg Period 1, Then Upa 22 mg Period 2 | 0 | 33 | 0 |
| other | DIARRHOEA | Gastrointestinal disorders | Placebo Period 1 | 1 | 46 | 1 |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Period 1 | 0 | 46 |
| Total, all-cause mortality | Upa 6 mg Period 1 | 0 | 49 |
| Total, all-cause mortality | Upa 11 mg Period 1 | 0 | 47 |
| Total, all-cause mortality | Upa 22 mg Period 1 | 1 | 43 |
| Total, all-cause mortality | Placebo Period 1, Then Upa 11 mg Period 2 | 0 | 21 |
| Total, all-cause mortality | Placebo Period 1, Then Upa 22 mg Period 2 | 0 | 22 |
| Total, all-cause mortality | Upa 6 mg Period 1, Then Upa 6 mg Period 2 | 0 | 45 |
| Total, all-cause mortality | Upa 11 mg Period 1, Then Upa 11 mg Period 2 | 0 | 45 |
| Total, all-cause mortality | Upa 22 mg Period 1, Then Upa 22 mg Period 2 | 0 | 33 |
| Total, other adverse events | Placebo Period 1 | 26 | 46 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04927975
GET https://conductscience.org/api/trials/v1/NCT04927975/results?page=2