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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-005126-37 | EudraCT Number |
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The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
This study includes a 35-day screening period, a 16-week double-blind period, a blinded extension period up to Week 260, a blinded Long-term Extension (LTE) Period after Week 260 to Week 524, and a 30-day follow-up visit. Participants who meet eligibility criteria in the Main Study will be randomly assigned in a 1:1:1 ratio to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily, in combination with topical corticosteroids.
Upon completion of enrollment of 810 participants in the Main Study, a supplemental study will continue to enroll adolescent participants (Adolescent Sub-study) until a total of 180 adolescent participants are enrolled in the overall study (Main Study + Adolescent Sub-study).
Approximately 1000 participants from M16-045 or M18-891 and approximately 500 participants from M16-047 will have the opportunity to enroll into the blinded Long-Term Extension (LTE) period (Week 260 - Week 524) after reaching Week 260 in their respective studies.
Randomization for the Main Study will be stratified by Baseline disease severity (validated Investigator Global Assessment Scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]), by geographic region (US/Puerto Rico/Canada, Japan, China, and Other), and by age (adolescent [ages 12 to 17] versus adult [ages 18 to 75]). The separate randomization for the Adolescent Sub-study will be stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]) and by geographic region (US/Puerto Rico/Canada and Other).
At Week 16 of both the Main Study and the Adolescent Sub-study, participants in the placebo group will be re-randomized in a 1:1 ratio to receive daily oral doses of upadacitinib 30 mg or upadacitinib 15 mg in the blinded extension period, and participants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose. For the Main Study, the re-randomization will be stratified by Eczema Area and Severity Index (EASI) 50 responder status (Yes/No), by geographic region (US/Puerto Rico/Canada, Japan, China, and Other) and by age (adolescent [ages 12 to 17] versus adult [ages 18 to 75]). For the Adolescent Sub-study, the re-randomization will be stratified by EASI 50 responder (Yes/No) and by geographic region (US/Puerto Rico/Canada and Other).
Starting at Week 4, rescue treatment for AD may be provided at the discretion of the investigator if medically necessary The Primary Analysis for the Main Study will be conducted after all ongoing participants have completed Week 16. In addition, a Primary Analysis for the adolescent population (including the adolescent participants from the Main Study and the Adolescent Sub-study) will be conducted after all ongoing adolescent participants have completed Week 16.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo / Upadacitinib + Topical Corticosteroids | Placebo Comparator | Participants will receive placebo orally once a day (QD) for 16 weeks in the double-blind treatment period. At Week 16 participants will be re-randomized to receive either upadacitinib 15 mg or upadacitinib 30 mg QD up to Week 260. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52. |
|
| Upadacitinib 15 mg QD + Topical Corticosteroids | Experimental | Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52. |
|
| Upadacitinib 30 mg QD + Topical Corticosteroids | Experimental | Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52. |
|
| Long-Term Extension | Experimental | Participants who reach Week 260 in Studies M16-045, M18-891, and M16-047 will have the opportunity to roll over into the blinded LTE period of M16-047 to continue receiving the same daily dose of upadacitinib for up to Week 524. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Tablets taken orally once a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Baseline and Week 16 |
| 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 | The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:
| Baseline and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Derm Ctr /ID# 200548 | Birmingham | Alabama | 35205 | United States | ||
| Clinical Research Center AL /ID# 201865 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40900410 | Derived | Irvine AD, Prajapati VH, Guttman-Yassky E, Simpson EL, Papp KA, Blauvelt A, Chu CY, Hong HC, Gold LFS, de Bruin-Weller M, Bieber T, Kabashima K, Rosmarin D, Sancho C, Calimlim BM, Grada A, Yang Y, Wu X, Levy G, Raymundo EM, Teixeira HD, Silverberg JI. Efficacy and Safety of Upadacitinib in Patients With Moderate-to-Severe Atopic Dermatitis: Phase 3 Randomized Clinical Trial Results Through 140 Weeks. Am J Clin Dermatol. 2025 Nov;26(6):1003-1016. doi: 10.1007/s40257-025-00975-3. Epub 2025 Sep 3. | |
| 40875187 |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Adults: Upadacitinib 15 mg + Topical Corticosteroids |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 29, 2020 | Feb 7, 2022 |
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|
| Upadacitinib |
| Drug |
Tablets taken orally once a day |
|
|
| Topical corticosteroids (TCS) | Drug | Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity. Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid. |
|
| Baseline (last available rolling average before the first dose of study drug) and Week 16 |
| Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16 | 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. | Baseline and Week 16 |
| Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4 | 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. | Baseline (last available rolling average before the first dose of study drug) and Week 4 |
| Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 4 | 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. | Baseline and Week 4 |
| Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2 | 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. | Baseline and Week 2 |
| Main Study: Percentage of Participants Achieving an EASI 90 Response at Week 4 | 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. | Baseline and Week 4 |
| Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16 | 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. | Baseline and Week 16 |
| Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1 | 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. | Baseline (last available rolling average before the first dose of study drug) and Week 1 |
| Main Study: Percent Change From Baseline in Worst Pruritus NRS at Week 16 | 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. | Baseline (last available rolling average before the first dose of study drug) and Week 16 |
| Main Study: Percent Change From Baseline in EASI Score at Week 16 | 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. | Baseline and Week 16 |
| Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16 | 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. | Baseline and Week 16 |
| Adolescents: Percentage of Participants Achieving a vIGA-AD of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16 | The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:
| Baseline and Week 16 |
| Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16 | 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. | Baseline (last available rolling average before the first dose of study drug) and Week 16 |
| Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16 | 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. | Baseline and Week 16 |
| Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4 | 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. | Baseline (last available rolling average before the first dose of study drug) and Week 4 |
| Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 4 | 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. | Baseline and Week 4 |
| Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2 | 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. | Baseline and Week 2 |
| Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 4 | 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. | Baseline and Week 4 |
| Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16 | 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. | Baseline and Week 16 |
| Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1 | 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. | Baseline (last available rolling average before the first dose of study drug) and Week 1 |
| Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16 | 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. | Baseline (last available rolling average before the first dose of study drug) and Week 16 |
| Adolescents: Percent Change From Baseline in EASI Score at Week 16 | 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. | Baseline and Week 16 |
| Birmingham |
| Alabama |
| 35209-6802 |
| United States |
| ACCEL Research Sites /ID# 213364 | Birmingham | Alabama | 35218 | United States |
| Advanced Dermatology and Skin Care Centre /ID# 213550 | Mobile | Alabama | 36605-3004 | United States |
| Alliance Dermatology and MOHs Center, PC /ID#200540 | Phoenix | Arizona | 85032 | United States |
| Arizona Research Center, Inc. /ID# 200546 | Phoenix | Arizona | 85053-4061 | United States |
| Clear Dermatology & Aesthetics Center /ID# 201257 | Scottsdale | Arizona | 85255-4134 | United States |
| University of Arizona /ID# 201059 | Tucson | Arizona | 85719 | United States |
| Bakersfield Derma & Skin Cance /ID# 200892 | Bakersfield | California | 93309 | United States |
| Mosaic Dermatology /ID# 200553 | Beverly Hills | California | 90211 | United States |
| University of California Irvine /ID# 200902 | Irvine | California | 92697-1385 | United States |
| Therapeutics Clinical Research /ID# 200593 | San Diego | California | 92123 | United States |
| Stanford University /ID# 200597 | Stanford | California | 94305 | United States |
| Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822 | Aurora | Colorado | 80045-2517 | United States |
| Colorado Center for Dermatology, PLLC /ID# 203626 | Centennial | Colorado | 80111-1724 | United States |
| Duplicate_Western States Clinical Research, Inc. /ID# 201702 | Wheat Ridge | Colorado | 80033-2896 | United States |
| Dermatology Physicians of Connecticut /ID# 201004 | Shelton | Connecticut | 06484-6211 | United States |
| Clearlyderm Dermatology /ID# 207709 | Boca Raton | Florida | 33428 | United States |
| Skin Care Research, LLC /ID# 200812 | Boca Raton | Florida | 33486-2269 | United States |
| Clinical Research of West Florida, Inc /ID# 203643 | Clearwater | Florida | 33765 | United States |
| Florida Academic Centers Research and Education /ID# 200544 | Coral Gables | Florida | 33134 | United States |
| Tory P Sullivan, MD PA /ID# 201174 | North Miami Beach | Florida | 33162-4708 | United States |
| Park Avenue Dermatology, PA /ID# 201012 | Orange Park | Florida | 32073 | United States |
| Precision Clinical Research /ID# 208734 | Sunrise | Florida | 33351-7311 | United States |
| Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628 | Boise | Idaho | 83713 | United States |
| Northwestern University Feinberg School of Medicine /ID# 201646 | Chicago | Illinois | 60611-2927 | United States |
| Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556 | Skokie | Illinois | 60077 | United States |
| DuPage Medical Group /ID# 202065 | Wheaton | Illinois | 60189-3801 | United States |
| Deaconess Clinic Downtown /ID# 201001 | Evansville | Indiana | 47713-1227 | United States |
| Indiana University /ID# 200515 | Indianapolis | Indiana | 46202 | United States |
| Epiphany Dermatology of Kansas LLC /ID# 203026 | Overland Park | Kansas | 66210 | United States |
| ORA, Inc. /ID# 202824 | Andover | Massachusetts | 01810 | United States |
| Tufts Medical Center /ID# 200570 | Boston | Massachusetts | 02111-1552 | United States |
| Beth Israel Deaconess Medical Center /ID# 200545 | Boston | Massachusetts | 02215-5400 | United States |
| Clin Res Inst of Michigan, LLC /ID# 208020 | Chesterfield | Michigan | 48047 | United States |
| Michigan Center for Research Company /ID# 200560 | Clarkston | Michigan | 48346 | United States |
| MediSearch Clinical Trials /ID# 201006 | Saint Joseph | Missouri | 64506 | United States |
| Skin Specialists, PC /ID# 200573 | Omaha | Nebraska | 68144 | United States |
| Dartmouth-Hitchcock Medical Center /ID# 200918 | Lebanon | New Hampshire | 03756 | United States |
| Psoriasis Treatment Center of Central New Jersey /ID# 200714 | East Windsor | New Jersey | 08520 | United States |
| Juva Skin and Laser Center /ID# 200997 | New York | New York | 10022-3204 | United States |
| J. Schwartz, MD, PLLC /ID# 202122 | Troy | New York | 12180-2323 | United States |
| Bexley Dermatology Research /ID# 200899 | Bexley | Ohio | 43209-2422 | United States |
| The Ohio State University /ID# 200542 | Columbus | Ohio | 43210-1257 | United States |
| Vital Prospects Clinical Research Institute, PC /ID# 200901 | Tulsa | Oklahoma | 74136-7049 | United States |
| Oregon Dermatology and Research Center /ID# 200601 | Portland | Oregon | 97210 | United States |
| University of Pittsburgh MC /ID# 206057 | Pittsburgh | Pennsylvania | 15260 | United States |
| Rhode Island Hospital /ID# 200566 | Providence | Rhode Island | 02903 | United States |
| AAPRI Clinical Research /ID# 221134 | Warwick | Rhode Island | 02886-2876 | United States |
| Rivergate Dermatology & Skin Care Center /ID# 201698 | Goodlettsville | Tennessee | 37072-2301 | United States |
| Stones River Dermatology /ID# 204962 | Murfreesboro | Tennessee | 37129-3194 | United States |
| Arlington Research Center, Inc /ID# 200559 | Arlington | Texas | 76011 | United States |
| Center for Clinical Studies /ID# 200582 | Houston | Texas | 77004 | United States |
| Progressive Clinical Research /ID# 201582 | San Antonio | Texas | 78229 | United States |
| Center for Clinical Studies - Webster TX /ID# 203186 | Webster | Texas | 77598 | United States |
| Advanced Clinical Research - Woseth Dermatology /ID# 213745 | Salt Lake City | Utah | 84117-4209 | United States |
| Eastern Virginia Med School /ID# 200994 | Norfolk | Virginia | 23507-1627 | United States |
| Dermatology Associates of Seattle /ID# 200717 | Seattle | Washington | 98101 | United States |
| University of Wisconsin - Madison /ID# 204933 | Madison | Wisconsin | 53715-1218 | United States |
| St George Dermatology & Skin Cancer Centre /ID# 204788 | Kogarah | New South Wales | 2217 | Australia |
| Royal North Shore Hospital /ID# 204639 | St Leonards | New South Wales | 2065 | Australia |
| Westmead Hospital /ID# 205682 | Westmead | New South Wales | 2145 | Australia |
| Veracity Clinical Research /ID# 204793 | Woolloongabba | Queensland | 4102 | Australia |
| Fremantle Dermatology /ID# 205306 | Fremantle | Western Australia | 6160 | Australia |
| Medizinische Universitaet Wien /ID# 201080 | Vienna | State of Vienna | 1090 | Austria |
| Medizinische Universitaet Innsbruck /ID# 210897 | Innsbruck | Tyrol | 6020 | Austria |
| Ordensklinikum Linz GmbH Elisabethinen /ID# 209567 | Linz | Upper Austria | 4010 | Austria |
| Kepler Universitaetsklinikum GmbH /ID# 201075 | Linz | Upper Austria | 4021 | Austria |
| UZ Brussel /ID# 203557 | Jette | Brussels Capital | 1090 | Belgium |
| UCL Saint-Luc /ID# 202028 | Woluwe-Saint-Lambert | Brussels Capital | 1200 | Belgium |
| UZ Gent /ID# 202030 | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| IMTR - Grand Hopital de Charleroi /ID# 202029 | Loverval | 6280 | Belgium |
| Kirk Barber Research, CA /ID# 200329 | Calgary | Alberta | T2G 1B1 | Canada |
| Dermatology Research Institute Inc. /ID# 200341 | Calgary | Alberta | T2J 7E1 | Canada |
| Alberta DermaSurgery Centre /ID# 205674 | Edmonton | Alberta | T6G 1C3 | Canada |
| Karma Clinical Trials /ID# 200339 | St. John's | Newfoundland and Labrador | A1A 4Y3 | Canada |
| Eastern Canada Cutaneous Resea /ID# 200335 | Halifax | Nova Scotia | B3H 1Z2 | Canada |
| Lynderm Research Inc. /ID# 200338 | Markham | Ontario | L3P 1X2 | Canada |
| DermEdge Research Inc. /ID# 200337 | Mississauga | Ontario | L5H 1G9 | Canada |
| The Centre for Clinical Trials /ID# 205404 | Oakville | Ontario | L6J 7W5 | Canada |
| Angela Montgomery Medicine Professional Corporation /ID# 212653 | Ottawa | Ontario | K1H 7X3 | Canada |
| SKIN Centre for Dermatology /ID# 200331 | Peterborough | Ontario | K9J 5K2 | Canada |
| The Center For Dermatology /ID# 205409 | Richmond Hill | Ontario | L4B 1A5 | Canada |
| Toronto Research Centre /ID# 205411 | Toronto | Ontario | M3H 5Y8 | Canada |
| Research Toronto /ID# 205410 | Toronto | Ontario | M4W 2N4 | Canada |
| XLR8 Medical Research /ID# 205405 | Windsor | Ontario | N8W 1E6 | Canada |
| CHU Sainte-Justine /ID# 206013 | Montreal | Quebec | H3T 1C5 | Canada |
| Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403 | Québec | Quebec | G1V 4X7 | Canada |
| Dre Angelique Gagne-Henley M.D. inc. /ID# 200330 | Saint-Jérôme | Quebec | J7Z 7E2 | Canada |
| Chinese PLA General Hospital /ID# 206786 | Beijing | Beijing Municipality | 100853 | China |
| Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728 | Guangzhou | Guangdong | 510120 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669 | Wuhan | Hubei | 430022 | China |
| The First Hospital of China Medical University /ID# 209840 | Shenyang | Liaoning | 110001 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132 | Hangzhou | Zhejiang | 310006 | China |
| The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442 | Hangzhou | Zhejiang | 310009 | China |
| Beijing Friendship Hospital /ID# 207434 | Beijing | 100032 | China |
| Xiangya Hospital Central South University /ID# 207510 | Changsha | 410008 | China |
| Huashan Hospital of Fudan University /ID# 207437 | Shanghai | 200040 | China |
| Fakultni nemocnice Plzen /ID# 202044 | Pilsen | 305 99 | Czechia |
| Sanatorium profesora Arenbergera /ID# 202082 | Prague | 110 00 | Czechia |
| Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248 | Prague | 128 08 | Czechia |
| Vseobecna fakultni nemocnice v Praze /ID# 202045 | Prague | 128 08 | Czechia |
| Chu de Nice-Hopital L'Archet Ii /Id# 205780 | Nice | Alpes-Maritimes | 06200 | France |
| AP-HM - Hopital de la Timone /ID# 206128 | Marseille | Bouches-du-Rhone | 13385 | France |
| CHRU Tours - Hopital Gatien de Clocheville /ID# 218209 | Tours | Centre-Val de Loire | 37044 | France |
| Hopital Saint-Andre /ID# 206129 | Bordeaux | 33075 | France |
| Polyclinique Courlancy /ID# 201537 | Reims | 51100 | France |
| Universitaetsklinik Heidelberg /ID# 202097 | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Universitaetsklinikum Frankfurt /ID# 202095 | Frankfurt am Main | Hesse | 60590 | Germany |
| Universitaetsklinikum Muenster /ID# 202094 | Münster | North Rhine-Westphalia | 48149 | Germany |
| CMS3 Company for Medical Study /ID# 205195 | Selters | Rhineland-Palatinate | 56242 | Germany |
| Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256 | Kiel | Schleswig-Holstein | 24105 | Germany |
| Universitaetsklinikum Bonn /ID# 202092 | Bonn | 53127 | Germany |
| TFS Trial Form Support GmbH /ID# 202096 | Hamburg | 20537 | Germany |
| Medizinische Hochschule Hannover /ID# 202098 | Hanover | 30625 | Germany |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194 | Mainz | 55131 | Germany |
| Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202093 | Munich | 81675 | Germany |
| 401 GSNA - 401 Army General Hospital /ID# 211963 | Athens | Attica | 11525 | Greece |
| Children's Hosp P. A. Kyriakou /ID# 217573 | Athens | Attica | 11527 | Greece |
| University General Hospital Attikon /ID# 201126 | Athens | Attica | 12462 | Greece |
| General Hospital Andreas Syggros /ID# 201123 | Athens | Attica | 16121 | Greece |
| Papageorgiou General Hospital Thessaloniki /ID# 202392 | Stavroupoli (Thessalonikis) | Thessaloniki | 55536 | Greece |
| Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124 | Thessaloniki | 54643 | Greece |
| Prince of Wales Hospital /ID# 205152 | Hong Kong | 999077 | Hong Kong |
| Queen Mary Hospital /ID# 205146 | Hong Kong | 999077 | Hong Kong |
| Oroshazi Korhaz /ID# 203525 | Orosháza | Bekes County | 5900 | Hungary |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 204144 | Szeged | Csongrád megye | 6725 | Hungary |
| Debreceni Egyetem Klinikai Kozpont /ID# 201765 | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 217866 | Debrecen | 4031 | Hungary |
| Allergo-Derm Bakos Kft. /ID# 205361 | Szolnok | 5000 | Hungary |
| St James Hospital /ID# 201118 | Dublin | Dublin | D08 NHY1 | Ireland |
| South Infirmary Victoria University Hospital /ID# 201079 | Cork | T12 X23H | Ireland |
| University Hospital Waterford /ID# 201253 | Waterford | X91 ER8E | Ireland |
| Soroka University Medical Center /ID# 206652 | Beersheba | Southern District | 8443901 | Israel |
| The Chaim Sheba Medical Center /ID# 201611 | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Tel Aviv Sourasky Medical Center /ID# 201608 | Tel Aviv | Tel Aviv | 6423906 | Israel |
| HaEmek Medical Center /ID# 201958 | Afula | 1834111 | Israel |
| Rabin Medical Center /ID# 201959 | Petah Tikva | 4941492 | Israel |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 203014 | Rome | Lazio | 00168 | Italy |
| Istituto Clinico Humanitas /ID# 200739 | Rozzano | Milano | 20089 | Italy |
| Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690 | Ancona | 60126 | Italy |
| A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200742 | Catania | 95123 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744 | Milan | 20122 | Italy |
| Azienda Ospedaliera Universitaria Federico II /ID# 200751 | Naples | 80131 | Italy |
| Chukyo Hospital /ID# 202311 | Nagoya | Aichi-ken | 457-8510 | Japan |
| Medical Corporation Matsuo Clinic /ID# 202312 | Fukuoka | Fukuoka | 819-0373 | Japan |
| Hiroshima University Hospital /ID# 201914 | Hiroshima | Hiroshima | 734-8551 | Japan |
| Medical Corporation Kojinkai Sapporo Skin Clinic /ID#258665 | Sapporo | Hokkaido | 060-0063 | Japan |
| Hiramoto skin clinic /ID# 204048 | Amagasaki-shi | Hyōgo | 661-0953 | Japan |
| National Hospital Organization Sagamihara National Hospital /ID# 201658 | Sagamihara-shi | Kanagawa | 252-0392 | Japan |
| Queens Square Medical Center dermatology allergology /ID# 203850 | Yokohama | Kanagawa | 220-6208 | Japan |
| University Hospital Kyoto Prefectural University of Medicine /ID#258604 | Kyoto | Kyoto | 602-8566 | Japan |
| Kyoto University Hospital /ID# 201654 | Kyoto | Kyoto | 606-8507 | Japan |
| Tohoku University Hospital /ID# 206322 | Sendai | Miyagi | 9808574 | Japan |
| Osaka Habikino Medical Center /ID# 204243 | Habikino-shi | Osaka | 583-8588 | Japan |
| Jichi Medical University Hospital /ID# 201913 | Shimotsuke-shi | Tochigi | 329-0498 | Japan |
| Juntendo University Hospital /ID# 202888 | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Tokai University Hachioji Hospital /ID# 201711 | Hachioji-shi | Tokyo | 192-0032 | Japan |
| Maruyama Dermatology Clinic /ID# 202350 | Koto-ku | Tokyo | 136-0074 | Japan |
| Yamate Dermatological Clinic /ID# 202130 | Shinjuku-ku | Tokyo | 1690075 | Japan |
| Erasmus Medisch Centrum /ID# 202196 | Rotterdam | South Holland | 3015 GD | Netherlands |
| Academisch Medisch Centrum /ID# 202193 | Amsterdam | 1105 AZ | Netherlands |
| Universitair Medisch Centrum Groningen /ID# 202195 | Groningen | 9713 GZ | Netherlands |
| Universitair Medisch Centrum Utrecht /ID# 202194 | Utrecht | 3584 CX | Netherlands |
| Clinical Trials NZ /ID# 205336 | Hamilton | 3204 | New Zealand |
| Haukeland University Hospital /ID# 201152 | Bergen | Hordaland | 5021 | Norway |
| Universitetssykehuset N-Norge, Harstad /ID# 201269 | Harstad | Troms | 9406 | Norway |
| Universitetssykehuset N-Norge, Tromso /ID# 201270 | Tromsø | Troms | 9019 | Norway |
| Rikshospitalet OUS HF /ID# 201271 | Oslo | 0450 | Norway |
| Dr. Samuel Sanchez PSC /ID# 202002 | Caguas | 00727 | Puerto Rico |
| Clinical Research Puerto Rico /ID# 203644 | San Juan | 00909 | Puerto Rico |
| GCM Medical Group PSC - Hato Rey /ID# 202003 | San Juan | 00917-3104 | Puerto Rico |
| Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 204372 | Banská Bystrica | 975 17 | Slovakia |
| Univerzitna nemocnica Martin /ID# 203851 | Martin | 036 01 | Slovakia |
| Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240 | Nové Zámky | 940 34 | Slovakia |
| Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 204373 | Prešov | 081 01 | Slovakia |
| Hospital Universitario de Puerto Real /ID# 200875 | Puerto Real | Cadiz | 11510 | Spain |
| Hospital General Universitario Alicante /ID# 200873 | Alicante | 03010 | Spain |
| Hospital Santa Creu i Sant Pau /ID# 201325 | Barcelona | 08041 | Spain |
| Hospital Universitario de la Princesa /ID# 201517 | Madrid | 28006 | Spain |
| Hospital Universitario 12 de Octubre /ID# 201135 | Madrid | 28041 | Spain |
| Hospital Universitario La Paz /ID# 205438 | Madrid | 28046 | Spain |
| Skane University Hospital Lund /ID# 201244 | Lund | Skåne County | SE 221 41 | Sweden |
| Sahlgrenska University Hospital /ID# 201274 | Gothenburg | Västra Götaland County | 413 46 | Sweden |
| Sodersjukhuset /ID# 201242 | Stockholm | 118 83 | Sweden |
| Karolinska University Hospital /ID# 201243 | Stockholm | 171 76 | Sweden |
| Barts Health NHS Trust /ID# 201044 | London | London, City of | E1 2ES | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust /ID# 201193 | London | London, City of | SE1 9RT | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust /ID# 204642 | London | London, City of | SE1 9RT | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust /ID# 202052 | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| NHS Tayside /ID# 202081 | Dundee | Scotland | DD2 1UB | United Kingdom |
| NHS Greater Glasgow and Clyde /ID# 201374 | Glasgow | Scotland | G12 0XH | United Kingdom |
| Leeds Teaching Hospitals NHS Trust /ID# 201106 | Leeds | LS9 7TF | United Kingdom |
| Derived |
| Burmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28. |
| 39441580 | Derived | Paller AS, Mendes-Bastos P, Siegfried E, Eichenfield LF, Soong W, Prajapati VH, Lio P, Simpson EL, Raymundo EM, Suravaram S, Hu X, Yang Y, Huang X, Calimlim BM, Platt AM, Su JC, Zheng M, Yamamoto-Hanada K, Teixeira HD, Irvine AD. Upadacitinib in Adolescents With Moderate to Severe Atopic Dermatitis: Analysis of 3 Phase 3 Randomized Clinical Trials Through 76 Weeks. JAMA Dermatol. 2024 Dec 1;160(12):1304-1313. doi: 10.1001/jamadermatol.2024.3696. |
| 37691437 | Derived | Silverberg JI, Leshem YA, Calimlim BM, McDonald J, Litcher-Kelly L. Psychometric evaluation of the Worst Pruritus Numerical Rating Scale (NRS), Atopic Dermatitis Symptom Scale (ADerm-SS), and Atopic Dermatitis Impact Scale (ADerm-IS). Curr Med Res Opin. 2023 Oct;39(10):1289-1296. doi: 10.1080/03007995.2023.2251883. Epub 2023 Sep 13. |
| 37247226 | Derived | Thyssen JP, Thaci D, Bieber T, Gooderham M, de Bruin-Weller M, Soong W, Kabashima K, Barbarot S, Luna PC, Xu J, Hu X, Liu Y, Raymundo EM, Calimlim BM, Nduaka C, Gamelli A, Simpson EL. Upadacitinib for moderate-to-severe atopic dermatitis: Stratified analysis from three randomized phase 3 trials by key baseline characteristics. J Eur Acad Dermatol Venereol. 2023 Sep;37(9):1871-1880. doi: 10.1111/jdv.19232. Epub 2023 Jun 21. |
| 37043227 | Derived | Paller AS, Ladizinski B, Mendes-Bastos P, Siegfried E, Soong W, Prajapati VH, Lio P, Thyssen JP, Simpson EL, Platt AM, Raymundo EM, Liu J, Calimlim BM, Huang X, Gu Y, Hu X, Yang Y, Su JC, Zheng M, Yamamoto-Hanada K, Teixeira HD, Irvine AD. Efficacy and Safety of Upadacitinib Treatment in Adolescents With Moderate-to-Severe Atopic Dermatitis: Analysis of the Measure Up 1, Measure Up 2, and AD Up Randomized Clinical Trials. JAMA Dermatol. 2023 May 1;159(5):526-535. doi: 10.1001/jamadermatol.2023.0391. |
| 36754548 | Derived | Burmester GR, Cohen SB, Winthrop KL, Nash P, Irvine AD, Deodhar A, Mysler E, Tanaka Y, Liu J, Lacerda AP, Palac H, Shaw T, Mease PJ, Guttman-Yassky E. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023 Feb;9(1):e002735. doi: 10.1136/rmdopen-2022-002735. |
| 36333616 | Derived | Silverberg JI, Simpson EL, Calimlim BM, Litcher-Kelly L, Li X, Sun X, Leshem YA. Determining Severity Strata for Three Atopic Dermatitis Patient-Reported Outcome Questionnaires: Defining Severity Score Ranges for the Worst Pruritus Numerical Rating Scale and the Atopic Dermatitis Symptom and Impact Scales (ADerm-SS and ADerm-IS). Dermatol Ther (Heidelb). 2022 Dec;12(12):2817-2827. doi: 10.1007/s13555-022-00836-5. Epub 2022 Nov 4. |
| 35714786 | Derived | Mendes-Bastos P, Ladizinski B, Guttman-Yassky E, Jiang P, Liu J, Prajapati VH, Simpson EL, Vigna N, Teixeira HD, Barbarot S. Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. J Am Acad Dermatol. 2022 Oct;87(4):784-791. doi: 10.1016/j.jaad.2022.06.012. Epub 2022 Jun 15. |
| 34023009 | Derived | Reich K, Teixeira HD, de Bruin-Weller M, Bieber T, Soong W, Kabashima K, Werfel T, Zeng J, Huang X, Hu X, Hendrickson BA, Ladizinski B, Chu AD, Silverberg JI. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021 Jun 5;397(10290):2169-2181. doi: 10.1016/S0140-6736(21)00589-4. Epub 2021 May 21. |
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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
|
| Received Study Drug |
|
| COMPLETED | Completed Week 16 |
|
| NOT COMPLETED |
|
|
All randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adults: Placebo + Topical Corticosteroids | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Study Enrollment | Count of Participants | Participants |
| |||||||||||
| Geographic Region | Count of Participants | Participants |
| |||||||||||
| Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) | The vIGA-AD was used to assess the severity of atopic dermatitis based on lesion appearance on the following scale:
| Count of Participants | Participants |
| ||||||||||
| Eczema Area and Severity Index (EASI) Score | EASI is a tool 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 percentage of skin affected, and the severity of eczema (scored as none [0], mild [1], moderate [2], or severe [3]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease. | Mean | Standard Deviation | score on a scale |
| |||||||||
| Disease Duration since Diagnosis | Participants with available data | Mean | Standard Deviation | years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 16 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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 | The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:
| 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 16 |
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| Secondary | Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (last available rolling average before the first dose of study drug) and Week 16 |
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| Secondary | Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 16 |
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| Secondary | Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (last available rolling average before the first dose of study drug) and Week 4 |
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| Secondary | Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 4 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 4 |
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| Secondary | Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 2 |
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| Secondary | Main Study: Percentage of Participants Achieving an EASI 90 Response at Week 4 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 4 |
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| Secondary | Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 16 |
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| Secondary | Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (last available rolling average before the first dose of study drug) and Week 1 |
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| Secondary | Main Study: Percent Change From Baseline in Worst Pruritus NRS at Week 16 | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Baseline (last available rolling average before the first dose of study drug) and Week 16 |
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| Secondary | Main Study: Percent Change From Baseline in EASI Score at Week 16 | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Baseline and Week 16 |
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| Secondary | Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 16 |
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| Secondary | Adolescents: Percentage of Participants Achieving a vIGA-AD of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16 | The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:
| 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 16 |
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| Secondary | Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (last available rolling average before the first dose of study drug) and Week 16 |
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| Secondary | Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16 | 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. | Intent-to-treat population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 16 |
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| Secondary | Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (last available rolling average before the first dose of study drug) and Week 4 |
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| Secondary | Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 4 | 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. | Intent-to-treat population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 4 |
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| Secondary | Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2 | 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. | Intent-to-treat population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 2 |
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| Secondary | Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 4 | 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. | Intent-to-treat population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 4 |
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| Secondary | Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16 | 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. | Intent-to-treat population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 16 |
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| Secondary | Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (last available rolling average before the first dose of study drug) and Week 1 |
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| Secondary | Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16 | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Baseline (last available rolling average before the first dose of study drug) and Week 16 |
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| Secondary | Adolescents: Percent Change From Baseline in EASI Score at Week 16 | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Baseline and Week 16 |
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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.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adults: Placebo + Topical Corticosteroids | 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. | 0 | 264 | 9 | 264 | 99 | 264 |
| EG001 | 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. | 0 | 261 | 7 | 261 | 111 | 261 |
| EG002 | 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. | 0 | 260 | 4 | 260 | 123 | 260 |
| EG003 | Adolescents: Placebo + Topical Corticosteroids | 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. | 0 | 62 | 0 | 62 | 21 | 62 |
| EG004 | 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. | 0 | 60 | 1 | 60 | 24 | 60 |
| EG005 | 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. | 0 | 60 | 0 | 60 | 32 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| RETINAL DETACHMENT | Eye disorders | MedDRA (22.1) | Systematic Assessment |
| |
| RHEGMATOGENOUS RETINAL DETACHMENT | Eye disorders | MedDRA (22.1) | Systematic Assessment |
| |
| VASCULAR STENT THROMBOSIS | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| ANAL ABSCESS | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| PERITONSILLAR ABSCESS | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| PHARYNGITIS STREPTOCOCCAL | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| LIGAMENT RUPTURE | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| ADENOCARCINOMA OF COLON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| STATUS ASTHMATICUS | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| DERMATITIS EXFOLIATIVE GENERALISED | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| ERYTHRODERMIC ATOPIC DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA (22.1) | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
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| ORAL HERPES | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
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| STAPHYLOCOCCAL SKIN INFECTION | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
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| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
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| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA (22.1) | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
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| CATARRH | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
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| ACNE | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
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| DERMATITIS ATOPIC | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 3, 2020 | Feb 7, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613732 | upadacitinib |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
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| Cochran-Mantel-Haenszel | Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age [adolescent vs. adult]) | <0.001 | Adjusted Response Rate Difference | 38.1 | 2-Sided | 95 | 30.8 | 45.4 | Response Rate Difference = Upadacitinib - Placebo | Superiority | The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. |
| OG002 | Upadacitinib 30 mg + Topical Corticosteroids | 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. |
|
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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. |
|
|
|
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. |
| OG002 | Upadacitinib 30 mg + Topical Corticosteroids | 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. |
|
|
|
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. |
|
|
|
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. |
| OG002 | Upadacitinib 30 mg + Topical Corticosteroids | 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. |
|
|
|
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. |
| OG002 | Upadacitinib 30 mg + Topical Corticosteroids | 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. |
|
|
|
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.
| OG002 | Upadacitinib 30 mg + Topical Corticosteroids | 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. |
|
|
|
| Upadacitinib 15 mg + Topical Corticosteroids |
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. |
| OG002 | Upadacitinib 30 mg + Topical Corticosteroids | 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. |
|
|
|
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. |
|
|
|
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. |
|
|
|
| OG001 |
| Upadacitinib 15 mg + Topical Corticosteroids |
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. |
| OG002 | Upadacitinib 30 mg + Topical Corticosteroids | 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. |
|
|
|
| OG001 | 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. |
| OG002 | 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. |
|
|
|
| OG002 | 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. |
|
|
|
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: 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. |
| OG002 | 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. |
|
|
|
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: 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. |
| OG002 | 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. |
|
|
|
| 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. |
| OG002 | 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. |
|
|
|
| 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. |
| OG002 | 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. |
|
|
|
| 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. |
| OG002 | 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. |
|
|
|
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: 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. |
|
|
|
| OG001 |
| 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. |
| OG002 | 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. |
|
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