Trial Outcomes & Findings for A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (NCT NCT03568318)

NCT ID: NCT03568318

Last Updated: 2025-12-23

Results Overview

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 1533 participants
• Primary outcome timeframe: Baseline and Week 16
• Results posted on: 2025-12-23

Participant Flow

Participants were enrolled at 171 clinical sites in 22 countries in the Asia-Pacific region, Europe, Middle East, North America, and Oceania. The study included a 16-week double-blind treatment period followed by a blinded extension period (ongoing). The first 810 adults and adolescents enrolled constituted the Main Study; additional adolescents were enrolled in the Adolescent Substudy to ensure enrollment of a total of 180 adolescent participants overall. Results are reported up to Week 16.

Participants were randomized equally into 1 of 3 treatment groups, stratified by disease severity (validated Investigator Global Assessment Scale for Atopic Dermatitis [vIGA-AD] moderate [3] vs severe [4]), geographic region (US/Puerto Rico/Canada, Japan, China, and Other), and age (adolescent [ages 12 to 17] vs adult [ages 18 to 75]). Randomization for the adolescent substudy was stratified by disease severity (vIGA-AD 3 vs vIGA-AD 4) and geographic region (US/Puerto Rico/Canada vs Other).

Participant milestones

Measure	Adults: Placebo + Topical Corticosteroids Participants ≥ 18 years old received placebo orally once a day (QD) and topical corticosteroids (TCS) following a step-down regimen for 16 weeks in the double-blind treatment period.	Adults: Upadacitinib 15 mg + Topical Corticosteroids Participants ≥ 18 years old received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adults: Upadacitinib 30 mg + Topical Corticosteroids Participants ≥ 18 years old received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids Adolescent participants (12 - 17 years old) received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Overall Study STARTED	264	261	260	63	60	60
Overall Study Received Study Drug	264	261	260	62	60	60
Overall Study COMPLETED	244	249	250	59	58	60
Overall Study NOT COMPLETED	20	12	10	4	2	0

Reasons for withdrawal

Measure	Adults: Placebo + Topical Corticosteroids Participants ≥ 18 years old received placebo orally once a day (QD) and topical corticosteroids (TCS) following a step-down regimen for 16 weeks in the double-blind treatment period.	Adults: Upadacitinib 15 mg + Topical Corticosteroids Participants ≥ 18 years old received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adults: Upadacitinib 30 mg + Topical Corticosteroids Participants ≥ 18 years old received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids Adolescent participants (12 - 17 years old) received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Overall Study Adverse Event	3	1	1	0	1	0
Overall Study Withdrawal by Subject	6	5	2	1	0	0
Overall Study Lost to Follow-up	3	2	2	2	1	0
Overall Study Other	3	1	3	0	0	0
Overall Study Ongoing at Time of Analysis	5	3	2	1	0	0

Baseline Characteristics

Participants with available data

Baseline characteristics by cohort

Measure	Adults: Placebo + Topical Corticosteroids n=264 Participants Participants ≥ 18 years old received placebo orally once a day (QD) and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adults: Upadacitinib 15 mg + Topical Corticosteroids n=261 Participants Participants ≥ 18 years old received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adults: Upadacitinib 30 mg + Topical Corticosteroids n=260 Participants Participants ≥ 18 years old received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=63 Participants Adolescent participants (12 - 17 years old) received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=60 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=60 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Total n=968 Participants Total of all reporting groups
Age, Continuous	37.2 years STANDARD_DEVIATION 14.08 • n=264 Participants	35.0 years STANDARD_DEVIATION 13.29 • n=261 Participants	38.3 years STANDARD_DEVIATION 14.82 • n=260 Participants	15.1 years STANDARD_DEVIATION 1.85 • n=63 Participants	15.4 years STANDARD_DEVIATION 1.65 • n=60 Participants	15.3 years STANDARD_DEVIATION 1.86 • n=60 Participants	32.8 years STANDARD_DEVIATION 15.29 • n=968 Participants
Age, Customized 12 - 14 years	0 Participants n=264 Participants	0 Participants n=261 Participants	0 Participants n=260 Participants	23 Participants n=63 Participants	14 Participants n=60 Participants	21 Participants n=60 Participants	58 Participants n=968 Participants
Age, Customized 15 - 17 years	0 Participants n=264 Participants	0 Participants n=261 Participants	0 Participants n=260 Participants	40 Participants n=63 Participants	46 Participants n=60 Participants	39 Participants n=60 Participants	125 Participants n=968 Participants
Age, Customized 18 - < 40 years	156 Participants n=264 Participants	176 Participants n=261 Participants	158 Participants n=260 Participants	0 Participants n=63 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	490 Participants n=968 Participants
Age, Customized 40 - < 65 years	94 Participants n=264 Participants	80 Participants n=261 Participants	85 Participants n=260 Participants	0 Participants n=63 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	259 Participants n=968 Participants
Age, Customized ≥ 65 years	14 Participants n=264 Participants	5 Participants n=261 Participants	17 Participants n=260 Participants	0 Participants n=63 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	36 Participants n=968 Participants
Sex: Female, Male Female	101 Participants n=264 Participants	104 Participants n=261 Participants	95 Participants n=260 Participants	36 Participants n=63 Participants	27 Participants n=60 Participants	25 Participants n=60 Participants	388 Participants n=968 Participants
Sex: Female, Male Male	163 Participants n=264 Participants	157 Participants n=261 Participants	165 Participants n=260 Participants	27 Participants n=63 Participants	33 Participants n=60 Participants	35 Participants n=60 Participants	580 Participants n=968 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=264 Participants	21 Participants n=261 Participants	14 Participants n=260 Participants	7 Participants n=63 Participants	8 Participants n=60 Participants	7 Participants n=60 Participants	72 Participants n=968 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	249 Participants n=264 Participants	240 Participants n=261 Participants	246 Participants n=260 Participants	56 Participants n=63 Participants	52 Participants n=60 Participants	53 Participants n=60 Participants	896 Participants n=968 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=264 Participants	0 Participants n=261 Participants	0 Participants n=260 Participants	0 Participants n=63 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=968 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=264 Participants	2 Participants n=261 Participants	3 Participants n=260 Participants	0 Participants n=63 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	6 Participants n=968 Participants
Race (NIH/OMB) Asian	52 Participants n=264 Participants	57 Participants n=261 Participants	58 Participants n=260 Participants	14 Participants n=63 Participants	13 Participants n=60 Participants	6 Participants n=60 Participants	200 Participants n=968 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=264 Participants	3 Participants n=261 Participants	1 Participants n=260 Participants	0 Participants n=63 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	4 Participants n=968 Participants
Race (NIH/OMB) Black or African American	15 Participants n=264 Participants	15 Participants n=261 Participants	9 Participants n=260 Participants	5 Participants n=63 Participants	5 Participants n=60 Participants	6 Participants n=60 Participants	55 Participants n=968 Participants
Race (NIH/OMB) White	196 Participants n=264 Participants	177 Participants n=261 Participants	188 Participants n=260 Participants	44 Participants n=63 Participants	41 Participants n=60 Participants	46 Participants n=60 Participants	692 Participants n=968 Participants
Race (NIH/OMB) More than one race	0 Participants n=264 Participants	7 Participants n=261 Participants	1 Participants n=260 Participants	0 Participants n=63 Participants	1 Participants n=60 Participants	2 Participants n=60 Participants	11 Participants n=968 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=264 Participants	0 Participants n=261 Participants	0 Participants n=260 Participants	0 Participants n=63 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=968 Participants
Study Enrollment Main Study	264 Participants n=264 Participants	261 Participants n=261 Participants	260 Participants n=260 Participants	40 Participants n=63 Participants	39 Participants n=60 Participants	37 Participants n=60 Participants	901 Participants n=968 Participants
Study Enrollment Adolescent Substudy	0 Participants n=264 Participants	0 Participants n=261 Participants	0 Participants n=260 Participants	23 Participants n=63 Participants	21 Participants n=60 Participants	23 Participants n=60 Participants	67 Participants n=968 Participants
Geographic Region US/Puerto Rico/Canada	90 Participants n=264 Participants	90 Participants n=261 Participants	89 Participants n=260 Participants	31 Participants n=63 Participants	31 Participants n=60 Participants	31 Participants n=60 Participants	362 Participants n=968 Participants
Geographic Region Japan	18 Participants n=264 Participants	16 Participants n=261 Participants	17 Participants n=260 Participants	0 Participants n=63 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	51 Participants n=968 Participants
Geographic Region China	16 Participants n=264 Participants	15 Participants n=261 Participants	15 Participants n=260 Participants	2 Participants n=63 Participants	2 Participants n=60 Participants	1 Participants n=60 Participants	51 Participants n=968 Participants
Geographic Region Other	140 Participants n=264 Participants	140 Participants n=261 Participants	139 Participants n=260 Participants	30 Participants n=63 Participants	27 Participants n=60 Participants	28 Participants n=60 Participants	504 Participants n=968 Participants
Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) 3 (Moderate)	123 Participants n=264 Participants	124 Participants n=261 Participants	123 Participants n=260 Participants	28 Participants n=63 Participants	29 Participants n=60 Participants	29 Participants n=60 Participants	456 Participants n=968 Participants
Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) 4 (Severe)	141 Participants n=264 Participants	137 Participants n=261 Participants	137 Participants n=260 Participants	35 Participants n=63 Participants	31 Participants n=60 Participants	31 Participants n=60 Participants	512 Participants n=968 Participants
Eczema Area and Severity Index (EASI) Score	30.06 score on a scale STANDARD_DEVIATION 12.860 • n=264 Participants	29.03 score on a scale STANDARD_DEVIATION 11.925 • n=261 Participants	29.68 score on a scale STANDARD_DEVIATION 11.993 • n=260 Participants	30.25 score on a scale STANDARD_DEVIATION 12.105 • n=63 Participants	29.59 score on a scale STANDARD_DEVIATION 11.683 • n=60 Participants	28.68 score on a scale STANDARD_DEVIATION 10.143 • n=60 Participants	29.58 score on a scale STANDARD_DEVIATION 12.082 • n=968 Participants
Disease Duration since Diagnosis	25.986 years STANDARD_DEVIATION 15.5650 • n=264 Participants • Participants with available data	24.511 years STANDARD_DEVIATION 14.0363 • n=261 Participants • Participants with available data	24.617 years STANDARD_DEVIATION 16.6107 • n=260 Participants • Participants with available data	12.315 years STANDARD_DEVIATION 4.2769 • n=62 Participants • Participants with available data	11.370 years STANDARD_DEVIATION 5.0674 • n=60 Participants • Participants with available data	12.244 years STANDARD_DEVIATION 3.9262 • n=60 Participants • Participants with available data	22.584 years STANDARD_DEVIATION 14.9374 • n=967 Participants • Participants with available data

PRIMARY outcome

Timeframe: Baseline and Week 16

Population: The intent-to-treat population for the main study (ITT\_M) includes all participants who were randomized in the main study (adults and adolescents). Non-responder imputation incorporating multiple imputation to handle missing data due to coronavirus disease 2019 pandemic (COVID-19) (NRI-C) was used. The pre-specified primary analysis included participants enrolled in the main study only; Efficacy analyses of adolescent participants were conducted separately and are reported below.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=297 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=304 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=300 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16	77.1 percentage of participants Interval 72.3 to 81.9	26.4 percentage of participants Interval 21.5 to 31.4	64.6 percentage of participants Interval 59.1 to 70.0

PRIMARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:

• 0 - Clear: No inflammatory signs of AD;
• 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;
• 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;
• 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present;
• 4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=297 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=304 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=300 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16	58.6 percentage of participants Interval 53.0 to 64.2	10.9 percentage of participants Interval 7.4 to 14.4	39.6 percentage of participants Interval 34.1 to 45.2

SECONDARY outcome

Timeframe: Baseline (last available rolling average before the first dose of study drug) and Week 16

Population: Intent-to-treat population for the main study with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=291 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=294 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=288 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16	63.9 percentage of participants Interval 58.4 to 69.4	15.0 percentage of participants Interval 10.9 to 19.0	51.7 percentage of participants Interval 46.0 to 57.5

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/ neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=297 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=304 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=300 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16	63.1 percentage of participants Interval 57.6 to 68.6	13.2 percentage of participants Interval 9.4 to 17.0	42.8 percentage of participants Interval 37.2 to 48.4

SECONDARY outcome

Timeframe: Baseline (last available rolling average before the first dose of study drug) and Week 4

Population: Intent-to-treat population for the main study with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=291 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=294 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=288 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4	65.6 percentage of participants Interval 60.2 to 71.1	15.0 percentage of participants Interval 10.9 to 19.0	52.4 percentage of participants Interval 46.7 to 58.2

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=297 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=304 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=300 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 4	72.4 percentage of participants Interval 67.3 to 77.5	14.8 percentage of participants Interval 10.8 to 18.8	58.7 percentage of participants Interval 53.1 to 64.2

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=297 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=304 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=300 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2	44.1 percentage of participants Interval 38.5 to 49.8	6.9 percentage of participants Interval 4.1 to 9.8	31.0 percentage of participants Interval 25.8 to 36.2

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/ neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=297 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=304 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=300 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Main Study: Percentage of Participants Achieving an EASI 90 Response at Week 4	43.8 percentage of participants Interval 38.1 to 49.4	4.9 percentage of participants Interval 2.5 to 7.4	28.3 percentage of participants Interval 23.2 to 33.4

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored from 0 [none], to 3 [severe]) for redness, thickness, scratching, and lichenification.

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

The percentage of participants with an EASI 100 response at Week 16 was pre-specified as a ranked secondary endpoint for participants in the Upadacitinib 30 mg + Topical Corticosteroids group versus Placebo + Topical Corticosteroids group only.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=297 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=304 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=300 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16	22.6 percentage of participants Interval 17.8 to 27.3	1.3 percentage of participants Interval 0.0 to 2.6	12.0 percentage of participants Interval 8.3 to 15.7

SECONDARY outcome

Timeframe: Baseline (last available rolling average before the first dose of study drug) and Week 1

Population: Intent-to-treat population for the main study with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=291 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=294 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=288 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1	19.2 percentage of participants Interval 14.7 to 23.8	3.1 percentage of participants Interval 1.1 to 5.0	12.2 percentage of participants Interval 8.4 to 15.9

SECONDARY outcome

Timeframe: Baseline (last available rolling average before the first dose of study drug) and Week 16

Population: Intent-to-treat population for the main study with non-missing Baseline and Week 16 values; missing data were handled using a mixed-effect model with repeated measurements (MMRM) including observed measurements at all visits, except that measurements after any rescue medication were excluded.

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=247 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=184 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=260 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Main Study: Percent Change From Baseline in Worst Pruritus NRS at Week 16	-66.85 percent change Interval -72.99 to -60.72	-25.07 percent change Interval -31.64 to -18.49	-58.14 percent change Interval -64.24 to -52.05

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population for the main study with non-missing Baseline and Week 16 values; missing data were handled using a mixed-effect model with repeated measurements (MMRM) including observed measurements at all visits, except that measurements after any rescue medication were excluded.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1)] moderate [2], or severe [3]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=276 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=206 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=275 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Main Study: Percent Change From Baseline in EASI Score at Week 16	-87.31 percent change Interval -91.2 to -83.41	-45.86 percent change Interval -50.09 to -41.63	-77.99 percent change Interval -81.87 to -74.1

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The ITT population for adolescents (ITT\_A) consists of all adolescent participants who were randomized in the main study or the adolescent sub-study. Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=60 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=63 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=60 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16	84.3 percentage of participants Interval 74.9 to 93.6	30.3 percentage of participants Interval 18.9 to 41.6	63.3 percentage of participants Interval 51.1 to 75.5

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: The ITT population for adolescents (ITT\_A) consists of all adolescent participants who were randomized in the main study or the adolescent sub-study. Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:

• 0 - Clear: No signs of AD;
• 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;
• 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;
• 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting;
• 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=60 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=63 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=60 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Adolescents: Percentage of Participants Achieving a vIGA-AD of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16	67.4 percentage of participants Interval 55.5 to 79.4	11.2 percentage of participants Interval 3.4 to 19.1	38.3 percentage of participants Interval 26.0 to 50.6

SECONDARY outcome

Timeframe: Baseline (last available rolling average before the first dose of study drug) and Week 16

Population: Intent-to-treat population for adolescents with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=56 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=61 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=57 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16	51.8 percentage of participants Interval 38.7 to 64.9	21.3 percentage of participants Interval 11.0 to 31.6	45.6 percentage of participants Interval 32.7 to 58.5

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=60 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=63 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=60 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16	73.6 percentage of participants Interval 62.3 to 84.8	20.7 percentage of participants Interval 10.7 to 30.7	48.3 percentage of participants Interval 35.7 to 61.0

SECONDARY outcome

Timeframe: Baseline (last available rolling average before the first dose of study drug) and Week 4

Population: Intent-to-treat population for adolescents with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=56 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=61 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=57 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4	46.4 percentage of participants Interval 33.4 to 59.5	23.0 percentage of participants Interval 12.4 to 33.5	45.6 percentage of participants Interval 32.7 to 58.5

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: Intent-to-treat population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=60 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=63 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=60 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 4	78.3 percentage of participants Interval 67.9 to 88.8	28.6 percentage of participants Interval 17.4 to 39.7	54.9 percentage of participants Interval 42.3 to 67.5

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: Intent-to-treat population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=60 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=63 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=60 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2	51.7 percentage of participants Interval 39.0 to 64.3	9.5 percentage of participants Interval 2.3 to 16.8	33.7 percentage of participants Interval 21.7 to 45.8

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: Intent-to-treat population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=60 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=63 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=60 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 4	45.0 percentage of participants Interval 32.4 to 57.6	9.5 percentage of participants Interval 2.3 to 16.8	34.2 percentage of participants Interval 22.1 to 46.3

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

EASI is used to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. and the severity score is calculated as the sum of the intensity scores (scored from 0 [none], to 3 [severe]) for redness, thickness, scratching, and lichenification.

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

An EASI 100 response is defined as a 100% reduction (improvement) from Baseline in EASI score.

The percentage of participants with an EASI 100 response at Week 16 was pre-specified as a secondary endpoint for participants in the Upadacitinib 30 mg + TCS group versus Placebo + TCS group only.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=60 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=63 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=60 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16	25.0 percentage of participants Interval 14.0 to 36.0	4.8 percentage of participants Interval 0.0 to 10.0	13.3 percentage of participants Interval 4.7 to 21.9

SECONDARY outcome

Timeframe: Baseline (last available rolling average before the first dose of study drug) and Week 1

Population: Intent-to-treat population for adolescents with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=56 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=61 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=57 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1	16.1 percentage of participants Interval 6.5 to 25.7	9.8 percentage of participants Interval 2.4 to 17.3	8.8 percentage of participants Interval 1.4 to 16.1

SECONDARY outcome

Timeframe: Baseline (last available rolling average before the first dose of study drug) and Week 16

Population: Intent-to-treat population for adolescents with non-missing Baseline and Week 16 values; missing data were handled using a mixed-effect model with repeated measurements including observed measurements at all visits, except that measurements after any rescue medication were excluded.

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=49 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=41 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=50 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16	-49.02 percent change Interval -65.35 to -32.69	-32.96 percent change Interval -49.87 to -16.05	-59.34 percent change Interval -75.78 to -42.9

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population for adolescents with non-missing Baseline and Week 16 values; missing data were handled using a mixed-effect model with repeated measurements including observed measurements at all visits, except that measurements after any rescue medication were excluded.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1)] moderate [2], or severe [3]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.

Outcome measures

Measure	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=58 Participants Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=48 Participants Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=55 Participants Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Adolescents: Percent Change From Baseline in EASI Score at Week 16	-89.22 percent change Interval -96.49 to -81.95	-53.53 percent change Interval -61.23 to -45.82	-77.90 percent change Interval -85.36 to -70.44

Adverse Events

Adults: Placebo + Topical Corticosteroids

Serious events: 9 serious events

Other events: 99 other events

Deaths: 0 deaths

Adults: Upadacitinib 15 mg + Topical Corticosteroids

Serious events: 7 serious events

Other events: 111 other events

Deaths: 0 deaths

Adults: Upadacitinib 30 mg + Topical Corticosteroids

Serious events: 4 serious events

Other events: 123 other events

Deaths: 0 deaths

Adolescents: Placebo + Topical Corticosteroids

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Adolescents: Upadacitinib 15 mg + Topical Corticosteroids

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Adolescents: Upadacitinib 30 mg + Topical Corticosteroids

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adults: Placebo + Topical Corticosteroids n=264 participants at risk Participants ≥ 18 years old received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adults: Upadacitinib 15 mg + Topical Corticosteroids n=261 participants at risk Participants ≥ 18 years old received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adults: Upadacitinib 30 mg + Topical Corticosteroids n=260 participants at risk Participants ≥ 18 years old received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=62 participants at risk Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=60 participants at risk Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=60 participants at risk Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Blood and lymphatic system disorders PANCYTOPENIA	0.00% 0/264 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/261 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.38% 1/260 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.00% 0/264 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/261 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.38% 1/260 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Eye disorders RETINAL DETACHMENT	0.00% 0/264 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.38% 1/261 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Eye disorders RHEGMATOGENOUS RETINAL DETACHMENT	0.38% 1/264 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/261 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
General disorders VASCULAR STENT THROMBOSIS	0.38% 1/264 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/261 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Immune system disorders ANAPHYLACTIC REACTION	0.38% 1/264 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/261 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.38% 1/260 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Infections and infestations ANAL ABSCESS	0.38% 1/264 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/261 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Infections and infestations APPENDICITIS	0.00% 0/264 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.38% 1/261 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Infections and infestations PERITONSILLAR ABSCESS	0.00% 0/264 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.38% 1/261 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Infections and infestations PHARYNGITIS STREPTOCOCCAL	0.00% 0/264 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.38% 1/261 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Infections and infestations PNEUMONIA	0.38% 1/264 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/261 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Infections and infestations STAPHYLOCOCCAL SEPSIS	0.38% 1/264 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/261 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Infections and infestations URINARY TRACT INFECTION	0.38% 1/264 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/261 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Injury, poisoning and procedural complications LIGAMENT RUPTURE	0.00% 0/264 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/261 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.7% 1/60 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Injury, poisoning and procedural complications OVERDOSE	0.00% 0/264 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.38% 1/261 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA OF COLON	0.00% 0/264 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/261 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.38% 1/260 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Renal and urinary disorders HYDRONEPHROSIS	0.00% 0/264 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.38% 1/261 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Renal and urinary disorders NEPHROLITHIASIS	0.00% 0/264 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.38% 1/261 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.38% 1/264 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/261 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/264 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.38% 1/261 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/264 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.38% 1/261 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/264 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.38% 1/261 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Respiratory, thoracic and mediastinal disorders STATUS ASTHMATICUS	0.00% 0/264 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.38% 1/261 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Skin and subcutaneous tissue disorders DERMATITIS EXFOLIATIVE GENERALISED	0.38% 1/264 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/261 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Skin and subcutaneous tissue disorders ECZEMA	0.38% 1/264 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/261 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Skin and subcutaneous tissue disorders ERYTHRODERMIC ATOPIC DERMATITIS	0.38% 1/264 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/261 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Vascular disorders HAEMATOMA	0.38% 1/264 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/261 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.

Other adverse events

Measure	Adults: Placebo + Topical Corticosteroids n=264 participants at risk Participants ≥ 18 years old received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adults: Upadacitinib 15 mg + Topical Corticosteroids n=261 participants at risk Participants ≥ 18 years old received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adults: Upadacitinib 30 mg + Topical Corticosteroids n=260 participants at risk Participants ≥ 18 years old received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Placebo + Topical Corticosteroids n=62 participants at risk Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 15 mg + Topical Corticosteroids n=60 participants at risk Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.	Adolescents: Upadacitinib 30 mg + Topical Corticosteroids n=60 participants at risk Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
Nervous system disorders HEADACHE	4.5% 12/264 • Number of events 13 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	4.2% 11/261 • Number of events 13 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	4.2% 11/260 • Number of events 15 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	6.5% 4/62 • Number of events 5 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	8.3% 5/60 • Number of events 5 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	6.7% 4/60 • Number of events 4 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Respiratory, thoracic and mediastinal disorders CATARRH	0.00% 0/264 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.77% 2/261 • Number of events 2 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.6% 1/62 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	3.3% 2/60 • Number of events 2 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	5.0% 3/60 • Number of events 3 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Respiratory, thoracic and mediastinal disorders COUGH	1.5% 4/264 • Number of events 5 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	3.8% 10/261 • Number of events 11 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	3.8% 10/260 • Number of events 10 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	5.0% 3/60 • Number of events 3 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.7% 1/60 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Skin and subcutaneous tissue disorders ACNE	2.3% 6/264 • Number of events 6 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	9.6% 25/261 • Number of events 27 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	13.8% 36/260 • Number of events 39 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.6% 1/62 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	13.3% 8/60 • Number of events 9 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	15.0% 9/60 • Number of events 9 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Skin and subcutaneous tissue disorders DERMATITIS ATOPIC	6.8% 18/264 • Number of events 19 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	3.1% 8/261 • Number of events 8 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.77% 2/260 • Number of events 2 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	6.5% 4/62 • Number of events 5 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	5.0% 3/60 • Number of events 3 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	8.0% 21/264 • Number of events 24 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	7.7% 20/261 • Number of events 21 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	7.3% 19/260 • Number of events 21 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.6% 1/62 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.7% 1/60 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	6.7% 4/60 • Number of events 7 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	1.1% 3/264 • Number of events 3 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.9% 5/261 • Number of events 6 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.2% 3/260 • Number of events 3 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.6% 1/62 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	5.0% 3/60 • Number of events 4 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	2.7% 7/264 • Number of events 7 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	4.6% 12/261 • Number of events 12 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	6.2% 16/260 • Number of events 16 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.6% 1/62 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.7% 1/60 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	5.0% 3/60 • Number of events 3 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Gastrointestinal disorders DIARRHOEA	1.5% 4/264 • Number of events 4 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	3.8% 10/261 • Number of events 10 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	3.5% 9/260 • Number of events 10 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	6.5% 4/62 • Number of events 4 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.7% 1/60 • Number of events 2 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	5.0% 3/60 • Number of events 3 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Gastrointestinal disorders VOMITING	0.76% 2/264 • Number of events 2 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.38% 1/261 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/260 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.6% 1/62 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.7% 1/60 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	6.7% 4/60 • Number of events 4 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
General disorders PYREXIA	1.1% 3/264 • Number of events 3 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.9% 5/261 • Number of events 5 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.2% 3/260 • Number of events 3 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/62 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	6.7% 4/60 • Number of events 5 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Infections and infestations NASOPHARYNGITIS	11.7% 31/264 • Number of events 38 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	11.9% 31/261 • Number of events 38 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	14.2% 37/260 • Number of events 42 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	4.8% 3/62 • Number of events 3 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	10.0% 6/60 • Number of events 8 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	5.0% 3/60 • Number of events 3 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Infections and infestations ORAL HERPES	1.9% 5/264 • Number of events 7 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	3.4% 9/261 • Number of events 13 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	8.5% 22/260 • Number of events 26 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.6% 1/62 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	3.3% 2/60 • Number of events 2 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.7% 1/60 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Infections and infestations STAPHYLOCOCCAL SKIN INFECTION	0.38% 1/264 • Number of events 2 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.38% 1/261 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.38% 1/260 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	6.5% 4/62 • Number of events 5 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.7% 1/60 • Number of events 2 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/264 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	2.3% 6/261 • Number of events 7 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.77% 2/260 • Number of events 3 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	1.6% 1/62 • Number of events 1 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	0.00% 0/60 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.	5.0% 3/60 • Number of events 3 • From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.

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