Study to Evaluate Adverse Events and Change in Disease Ac... | NCT04927975

NCT04927975

ID	Type	Description	Link
2021-000081-15	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Upa 22 mg Period 1, then Upa 22 mg Period 2	Experimental	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
Upa 11 mg Period 1, then Upa 11 mg Period 2	Experimental	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
Upa 6 mg Period 1, then Upa 6 mg Period 2	Experimental	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
Placebo Period 1, then Upa 22 mg Period 2	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Upadacitinib	Drug	Oral tablets	Placebo Period 1, then Upa 11 mg Period 2 Placebo Period 1, then Upa 22 mg Period 2 Upa 11 mg Period 1, then Upa 11 mg Period 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline, Week 24

Secondary Outcomes

Measure	Description	Time Frame
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.	Baseline, Week 24

Eligibility Module

Eligibility Criteria

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:

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;

Contacts/Locations Module

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of California Irvine /ID# 229390		Irvine	California	92697-1385	United States
Stanford University /ID# 228000

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39475960	Derived	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.
38873632	Derived	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.

Label	URL
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo Period 1	Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1.
FG001	Placebo Period 1, Then Upa 11 mg Period 2

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 7, 2021	Aug 27, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

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

Upa 6 mg Period 1, then Upa 6 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.

FG00046 subjects
FG0010 subjects
FG0020 subjects
FG00349 subjects
FG00447 subjects
FG00543 subjects

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

Arm/Group Information

ID	Title	Description
BG000	Placebo Period 1	Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1.
BG001	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.
BG002	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.
BG003	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.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00046.8± 10.48 BG00145.1± 11.68 BG00245.5± 11.90 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00029 BG00126 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0005 BG0016 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Total Vitiligo Area Scoring Index (T-VASI)

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.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00021.014± 16.9516 BG001

Facial Vitiligo Area Scoring Index (F-VASI)

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.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0001.043± 0.6094 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Posted

Least Squares Mean

95% Confidence Interval

Percent change from baseline

Baseline, Week 24

ID	Title	Description
OG000	Placebo Period 1	Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1.
OG001	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.
OG002	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.
OG003	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.

Units	Counts
Participants	OG00043 OG00145 OG00243 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-14.36(-24.86 to -3.85) OG001-21.96(-32.18 to -11.75) OG002-35.63(-46.11 to -25.14) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Upa 6 mg Period 1 versus Placebo Period 1	Mixed-Effect Model Repeat Measurement		0.304		LS Mean Difference	-7.60			2-Sided	95	-22.18	6.97					Superiority	Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age [≤ 50 and > 50], Baseline disease severity [T-VASI < 15 and ≥ 15], active vitiligo [Yes/No]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.

Secondary

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

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, Week 24

ID	Title	Description
OG000	Placebo Period 1	Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1.
OG001	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.
OG002	Upa 11 mg Period 1, Then Upa 11 mg Period 2

Secondary

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

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, Week 24

ID	Title	Description
OG000	Placebo Period 1	Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1.
OG001	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.
OG002	Upa 11 mg Period 1, Then Upa 11 mg Period 2

Secondary

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

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, Week 24

ID	Title	Description
OG000	Placebo Period 1	Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1.
OG001	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.

Secondary

Percent Change From Baseline in T-VASI at Week 24

Posted

Least Squares Mean

95% Confidence Interval

Percent change from baseline

Baseline, Week 24

ID	Title	Description
OG000	Placebo Period 1	Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1.
OG001	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.

Secondary

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.

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Baseline, Week 24

ID	Title	Description
OG000	Placebo Period 1	Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1.
OG001	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo Period 1	Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1. AEs and SAEs were collected from the time of informed consent and during Period 1, as long as it did not exceed the start date of Period 2.	0	46	1	46	26	46
EG001	Upa 6 mg Period 1	Participants received upadacitinib 6 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. AEs and SAEs were collected from the time of informed consent and during Period 1, as long as it did not exceed the start date of Period 2.	0	49	1	49	19	49
EG002	Upa 11 mg Period 1	Participants received upadacitinib 11 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. AEs and SAEs were collected from the time of informed consent and during Period 1, as long as it did not exceed the start date of Period 2.	0	47	0	47	28	47
EG003	Upa 22 mg Period 1	Participants received upadacitinib 22 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. AEs and SAEs were collected from the time of informed consent and during Period 1, as long as it did not exceed the start date of Period 2.	1	43	3	43	23	43
EG004	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. AEs and SAEs were collected from the start date of Period 2 to the end of the study.	0	21	1	21	9	21
EG005	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. AEs and SAEs were collected from the start date of Period 2 to the end of the study.	0	22	0	22	11	22
EG006	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. AEs and SAEs were collected from the start date of Period 2 to the end of the study.	0	45	0	45	12	45
EG007	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. AEs and SAEs were collected from the start date of Period 2 to the end of the study.	0	45	2	45	22	45
EG008	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. AEs and SAEs were collected from the start date of Period 2 to the end of the study.	0	33	0	33	17	33

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ARTERIOSCLEROSIS CORONARY ARTERY	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected49 at risk EG0020 events0 affected47 at risk EG0030 events0 affected43 at risk EG0040 events0 affected21 at risk EG0050 events0 affected22 at risk EG0060 events0 affected45 at risk EG0070 events0 affected45 at risk EG0080 events0 affected33 at risk
DEATH	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected46 at risk EG0010 events0 affected49 at risk EG0020 events0 affected47 at risk EG003
PAIN	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected46 at risk EG0010 events0 affected49 at risk EG0020 events0 affected47 at risk EG003
COVID-19 PNEUMONIA	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected46 at risk EG0010 events0 affected49 at risk EG0020 events0 affected47 at risk EG003
CLAVICLE FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected46 at risk EG0010 events0 affected49 at risk EG0020 events0 affected47 at risk EG003
INVASIVE LOBULAR BREAST CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected46 at risk EG0010 events0 affected49 at risk EG0020 events0 affected47 at risk EG003
ISCHAEMIC STROKE	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected46 at risk EG0010 events0 affected49 at risk EG0020 events0 affected47 at risk EG003
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected49 at risk EG0020 events0 affected47 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0005 events4 affected46 at risk EG0010 events0 affected49 at risk EG0020 events0 affected47 at risk EG0030 events0 affected43 at risk EG0040 events0 affected21 at risk EG0050 events0 affected22 at risk EG0060 events0 affected45 at risk EG0070 events0 affected45 at risk EG0080 events0 affected33 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected49 at risk EG0023 events3 affected47 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected46 at risk EG0010 events0 affected49 at risk EG0022 events2 affected47 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected49 at risk EG0022 events2 affected47 at risk EG003
FATIGUE	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected46 at risk EG0012 events2 affected49 at risk EG0022 events2 affected47 at risk EG003
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected46 at risk EG0011 events1 affected49 at risk EG0020 events0 affected47 at risk EG003
COVID-19	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0008 events8 affected46 at risk EG0017 events7 affected49 at risk EG0029 events9 affected47 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected46 at risk EG0010 events0 affected49 at risk EG0021 events1 affected47 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0005 events3 affected46 at risk EG0014 events4 affected49 at risk EG0022 events2 affected47 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected46 at risk EG0013 events3 affected49 at risk EG0022 events2 affected47 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected46 at risk EG0011 events1 affected49 at risk EG0027 events4 affected47 at risk EG003
SKIN LACERATION	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected46 at risk EG0010 events0 affected49 at risk EG0020 events0 affected47 at risk EG003
BLOOD THYROID STIMULATING HORMONE DECREASED	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected49 at risk EG0020 events0 affected47 at risk EG003
WEIGHT INCREASED	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected49 at risk EG0021 events1 affected47 at risk EG003
HEADACHE	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0004 events4 affected46 at risk EG0010 events0 affected49 at risk EG00211 events9 affected47 at risk EG003
ANXIETY	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected49 at risk EG0023 events3 affected47 at risk EG003
INSOMNIA	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected46 at risk EG0010 events0 affected49 at risk EG0023 events3 affected47 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected46 at risk EG0012 events2 affected49 at risk EG0024 events4 affected47 at risk EG003
ACNE	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0004 events1 affected46 at risk EG0013 events3 affected49 at risk EG0024 events4 affected47 at risk EG003
DYSHIDROTIC ECZEMA	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected46 at risk EG0010 events0 affected49 at risk EG0020 events0 affected47 at risk EG003

First MCP Posted Date

ID	Term
D014820	Vitiligo

ID	Term
C000613732	upadacitinib

BG00222.322± 18.1784

BG00321.843± 15.9324

BG00421.534± 16.6634

EG0040 events0 affected21 at risk

EG0050 events0 affected22 at risk

EG0060 events0 affected45 at risk

EG0070 events0 affected45 at risk

EG0080 events0 affected33 at risk

EG0040 events0 affected21 at risk

EG0050 events0 affected22 at risk

EG0060 events0 affected45 at risk

EG0070 events0 affected45 at risk

EG0080 events0 affected33 at risk

EG0040 events0 affected21 at risk

EG0050 events0 affected22 at risk

EG0060 events0 affected45 at risk

EG0070 events0 affected45 at risk

EG0080 events0 affected33 at risk

EG0041 events1 affected21 at risk

EG0050 events0 affected22 at risk

EG0060 events0 affected45 at risk

EG0070 events0 affected45 at risk

EG0080 events0 affected33 at risk

EG0040 events0 affected21 at risk

EG0050 events0 affected22 at risk

EG0060 events0 affected45 at risk

EG0071 events1 affected45 at risk

EG0080 events0 affected33 at risk

EG0040 events0 affected21 at risk

EG0050 events0 affected22 at risk

EG0060 events0 affected45 at risk

EG0071 events1 affected45 at risk

EG0080 events0 affected33 at risk

EG0040 events0 affected21 at risk

EG0050 events0 affected22 at risk

EG0060 events0 affected45 at risk

EG0070 events0 affected45 at risk

EG0080 events0 affected33 at risk

EG0041 events1 affected21 at risk

EG0050 events0 affected22 at risk

EG0061 events1 affected45 at risk

EG0071 events1 affected45 at risk

EG0080 events0 affected33 at risk

EG0040 events0 affected21 at risk

EG0050 events0 affected22 at risk

EG0060 events0 affected45 at risk

EG0071 events1 affected45 at risk

EG0080 events0 affected33 at risk

EG0040 events0 affected21 at risk

EG0050 events0 affected22 at risk

EG0060 events0 affected45 at risk

EG0070 events0 affected45 at risk

EG0081 events1 affected33 at risk

EG0041 events1 affected21 at risk

EG0050 events0 affected22 at risk

EG0062 events2 affected45 at risk

EG0070 events0 affected45 at risk

EG0080 events0 affected33 at risk

EG0040 events0 affected21 at risk

EG0050 events0 affected22 at risk

EG0060 events0 affected45 at risk

EG0071 events1 affected45 at risk

EG0083 events2 affected33 at risk

EG0041 events1 affected21 at risk

EG0055 events5 affected22 at risk

EG0067 events7 affected45 at risk

EG00712 events12 affected45 at risk

EG0085 events5 affected33 at risk

EG0040 events0 affected21 at risk

EG0050 events0 affected22 at risk

EG0060 events0 affected45 at risk

EG0070 events0 affected45 at risk

EG0081 events1 affected33 at risk

EG0044 events3 affected21 at risk

EG0053 events3 affected22 at risk

EG0061 events1 affected45 at risk

EG0072 events2 affected45 at risk

EG0082 events2 affected33 at risk

EG0043 events3 affected21 at risk

EG0050 events0 affected22 at risk

EG0062 events1 affected45 at risk

EG0074 events4 affected45 at risk

EG0083 events3 affected33 at risk

EG0040 events0 affected21 at risk

EG0053 events3 affected22 at risk

EG0062 events2 affected45 at risk

EG0072 events1 affected45 at risk

EG0080 events0 affected33 at risk

EG0042 events2 affected21 at risk

EG0050 events0 affected22 at risk

EG0060 events0 affected45 at risk

EG0070 events0 affected45 at risk

EG0080 events0 affected33 at risk

EG0040 events0 affected21 at risk

EG0050 events0 affected22 at risk

EG0060 events0 affected45 at risk

EG0073 events3 affected45 at risk

EG0080 events0 affected33 at risk

EG0040 events0 affected21 at risk

EG0050 events0 affected22 at risk

EG0060 events0 affected45 at risk

EG0071 events1 affected45 at risk

EG0082 events2 affected33 at risk

EG0042 events2 affected21 at risk

EG0051 events1 affected22 at risk

EG0062 events2 affected45 at risk

EG0075 events5 affected45 at risk

EG0082 events2 affected33 at risk

EG0040 events0 affected21 at risk

EG0050 events0 affected22 at risk

EG0060 events0 affected45 at risk

EG0070 events0 affected45 at risk

EG0080 events0 affected33 at risk

EG0040 events0 affected21 at risk

EG0050 events0 affected22 at risk

EG0060 events0 affected45 at risk

EG0070 events0 affected45 at risk

EG0080 events0 affected33 at risk

EG0040 events0 affected21 at risk

EG0051 events1 affected22 at risk

EG0060 events0 affected45 at risk

EG0071 events1 affected45 at risk

EG0081 events1 affected33 at risk

EG0041 events1 affected21 at risk

EG0053 events2 affected22 at risk

EG0062 events1 affected45 at risk

EG0072 events2 affected45 at risk

EG0083 events3 affected33 at risk

EG0040 events0 affected21 at risk

EG0051 events1 affected22 at risk

EG0060 events0 affected45 at risk

EG0070 events0 affected45 at risk

EG0082 events2 affected33 at risk

ID	Term
D017496	Hypopigmentation
D010859	Pigmentation Disorders
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases