A Study to Evaluate ABT-494 (Upadacitinib) in Adults With... | NCT02925117 | Trialant
NCT02925117
Sponsor
AbbVie
Status
Completed
Last Update Posted
Jul 16, 2020Actual
Enrollment
167Actual
Phase
Phase 2
Conditions
Atopic Dermatitis
Interventions
Upadacitinib
Placebo
Countries
United States
Australia
Canada
Finland
Germany
Japan
Netherlands
Spain
Protocol Section
Identification Module
NCT ID
NCT02925117
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M16-048
Secondary IDs
ID
Type
Description
Link
2016-002451-21
EudraCT Number
Brief Title
A Study to Evaluate ABT-494 (Upadacitinib) in Adults With Moderate to Severe Atopic Dermatitis
Official Title
A Phase 2b Multicenter, Randomized, Placebo-Controlled, Double-Blind Dose-Ranging Study to Evaluate ABT-494 (Upadacitinib) in Adult Subjects With Moderate to Severe Atopic Dermatitis
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Jul 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 25, 2016Actual
Primary Completion Date
Aug 10, 2017Actual
Completion Date
Jan 31, 2019Actual
First Submitted Date
Oct 4, 2016
First Submission Date that Met QC Criteria
Oct 4, 2016
First Posted Date
Oct 5, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 2, 2020
Results First Submitted that Met QC Criteria
Jul 1, 2020
Results First Posted Date
Jul 16, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Aug 1, 2018
Certification/Extension First Submitted that Passed QC Review
Aug 1, 2018
Certification/Extension First Posted Date
Aug 6, 2018Actual
Last Update Submitted Date
Jul 1, 2020
Last Update Posted Date
Jul 16, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The objective of this study was to evaluate the safety and efficacy of multiple doses of upadacitinib monotherapy versus placebo in the treatment of adults with moderate to severe atopic dermatitis (AD).
Detailed Description
The study was to include a 16-week double-blind treatment period (Period 1) and a 72-week double-blind treatment period (Period 2) for a total of 88 weeks of treatment. Participants who met eligibility criteria were to be randomized in a 1:1:1:1 ratio to one of the four treatment groups. Participants who completed Period 1 were re-randomized at Week 16 into a 72-week double-blind, placebo-controlled treatment period (Period 2) in a 1:1 ratio:
Group 1: Upadacitinib 7.5 mg once daily (QD) (Day 1 to Week 16) → upadacitinib 7.5 mg QD or placebo (Week 16 - and thereafter)
Group 2: Upadacitinib 15 mg QD (Day 1 to Week 16) → upadacitinib 15 mg QD or placebo (Week 16 and thereafter)
Group 3: Upadacitinib 30 mg QD (Day 1 to Week 16) → upadacitinib 30 mg QD or placebo (Week 16 - and thereafter)
Group 4: Matching placebo (Day 1 to Week 16) → upadacitinib 30 mg QD or placebo (Week 16 and thereafter)
In Period 1, discontinuation from study drug was mandatory for any participant with an Eczema Area and Severity Index (EASI) score worsening of 25% or more compared with their Baseline EASI score at any 2 consecutive scheduled study visits from Week 4 to Week 12.
In Period 2, blinded rescue therapy with upadacitinib 30 mg QD was provided after the first instance of a < EASI 50 response starting at the Week 20 visit (4 weeks after re-randomization into Period 2) for the remainder of the study.
Conditions Module
Conditions
Atopic Dermatitis
Keywords
ABT-494
Atopic Dermatitis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
167Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 30 mg upadacitinib or placebo once a day for 72 weeks in Period 2.
Drug: Upadacitinib
Drug: Placebo
Upadacitinib 7.5 mg
Experimental
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 7.5 mg upadacitinib or placebo QD for 72 weeks in Period 2.
Drug: Upadacitinib
Drug: Placebo
Upadacitinib 15 mg
Experimental
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 15 mg upadacitinib or placebo QD for 72 weeks in Period 2.
Drug: Upadacitinib
Drug: Placebo
Upadacitinib 30 mg
Experimental
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 30 mg upadacitinib or placebo QD for 72 weeks in Period 2.
Drug: Upadacitinib
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Upadacitinib
Drug
Tablet for oral use
Placebo
Upadacitinib 15 mg
Upadacitinib 30 mg
Upadacitinib 7.5 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Eczema Area and Severity Index (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
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved a 75% Reduction in EASI Score (EASI 75) at Week 16
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.
An EASI 75 response is defined as participants with at least a 75% reduction (improvement) in EASI score relative to the Baseline value.
Participants with missing values at Week 16 were counted as non-responders in this analysis (non-responder imputation).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Atopic dermatitis with a diagnosis confirmed by a dermatologist (according to the Hanifin and Rajka criteria) and onset of symptoms at least 1 year prior to Baseline.
Moderate to severe atopic dermatitis defined by an Eczema Area and Severity Index (EASI) ≥ 16, body surface area (BSA) ≥ 10% and an Investigators Global Assessment (IGA) score ≥ 3 at the Baseline visit.
Documented history (within 1 year prior to the screening visit) of inadequate response to treatment with topical corticosteroids (TCS), or topical calcineurin inhibitors (TCI), or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).
Twice daily use of an additive-free, bland emollient for at least 7 days prior to Baseline.
Exclusion Criteria:
Prior exposure to any systemic or topical Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, ruxolitinib, and filgotinib).
Treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin within 10 days prior to the Baseline visit.
Prior exposure to dupilumab or exposure to systemic therapies for AD including corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE4)-inhibitors and mycophenolate mofetil within 4 weeks prior to Baseline.
Prior exposure to any investigational systemic treatment within 30 days or 5 half-lives (whichever is longer) of the Baseline visit or is currently enrolled in another clinical study.
Guttman-Yassky E, Thaci D, Pangan AL, Hong HC, Papp KA, Reich K, Beck LA, Mohamed MF, Othman AA, Anderson JK, Gu Y, Teixeira HD, Silverberg JI. Upadacitinib in adults with moderate to severe atopic dermatitis: 16-week results from a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2020 Mar;145(3):877-884. doi: 10.1016/j.jaci.2019.11.025. Epub 2019 Nov 29.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
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.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria
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 in a 1:1:1:1 ratio, stratified by geographic region (US and Canada; European Union and Australia; and Japan). Participants who completed Period 1 were re-randomized at Week 16 in a 1:1 ratio within their original treatment group assignments to either upadacitinib or placebo. Rescue therapy was provided from Week 20.
Recruitment Details
Participants were enrolled at 36 sites in 8 countries (Australia, Canada, Finland, Germany, Japan, Netherlands, Spain, and the United States [US]).
The study included a 16-week double-blind treatment period (Period 1) followed by a a 72-week double-blind treatment period (Period 2) for a total of 88 weeks of treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 30 mg upadacitinib or placebo once a day for 72 weeks in Period 2.
Percentage of Participants Achieving an Investigator Global Assessment (IGA) of "0" or "1" at Week 16
The Investigator's Global Assessment for Atopic Dermatitis (IGA) was scored on the following scale:
0: Clear (No inflammatory signs of atopic dermatitis)
1: Almost Clear (Just perceptible erythema and just perceptible papulation/infiltration)
2: Mild (Mild erythema and mild papulation/infiltration)
3: Moderate (Moderate erythema and moderate papulation/infiltration)
4: Severe (Severe erythema and severe papulation/infiltration with or without oozing/crusting)
The percentage of participants with a score of 0 or 1 at Week 16 is reported.
Week 16
Percent Change From Baseline to Weeks 2, 8, and 16 in Pruritus Numerical Rating Scale (NRS)
Participants were asked to rate pruritus (itch) in the past 24 hours on a daily basis using a scale from 0 to 10, with 0 being no itch and 10 being the worst imaginable itch. The percent change from Baseline at each week was calculated from a rolling weekly average.
Baseline and Weeks 2, 8, and 16
Percent Change From Baseline in EASI Score at Week 8
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 8
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Weeks 8 and 16
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.
Baseline and Weeks 8 and 16
Percentage of Participants Who Achieved an EASI 75 Response at Week 8
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.
An EASI 75 response is defined as participants with at least a 75% reduction (improvement) in EASI score relative to the Baseline value.
Participants with missing values at Week 8 were counted as non-responders in this analysis (non-responder imputation).
Baseline and Week 8
Percentage of Participants Who Achieved an EASI 50 Response at Weeks 8 and 16
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.
An EASI 50 response is defined as participants with at least a 50% reduction (improvement) in EASI score relative to the Baseline value.
Participants with missing values at each time point were counted as non-responders in this analysis (non-responder imputation).
Baseline and Weeks 8 and 16
Percentage of Participants Who Achieved an EASI 90 Response at Weeks 8 and 16
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.
An EASI 90 response is defined as participants with at least a 90% reduction (improvement) in EASI score relative to the Baseline value.
Participants with missing values at each time point were counted as non-responders in this analysis (non-responder imputation).
Baseline and Weeks 8 and 16
Percentage of Participants Who Achieved a SCORAD 50 Response at Weeks 8 and 16
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).
A SCORAD 50 response is defined as participants with at least a 50% reduction (improvement) in SCORAD score relative to the Baseline value.
Participants with missing values were counted as non-responders in this analysis (non-responder imputation).
Baseline and Weeks 8 and 16
Percentage of Participants Who Achieved a SCORAD 75 Response at Weeks 8 and 16
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).
A SCORAD 75 response is defined as participants with at least a 75% reduction (improvement) in SCORAD score relative to the Baseline value.
Participants with missing values were counted as non-responders in this analysis (non-responder imputation).
Baseline and Weeks 8 and 16
Percentage of Participants Who Achieved a SCORAD 90 Response at Weeks 8 and 16
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).
A SCORAD 90 response is defined as participants with at least a 90% reduction (improvement) in SCORAD score relative to the Baseline value.
Participants with missing values were counted as non-responders in this analysis (non-responder imputation).
Baseline and Weeks 8 and 16
Percent Change From Re-randomization (Week 16) in EASI Score in Period 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; a negative change from Baseline indicates improvement.
Re-randomization (Week 16) and Weeks 20, 24, 32, 40, 52, 64, 76, and 88
Time to Loss of EASI 50 Response Relative to Baseline Among Participants Re-randomized as EASI 75 Responders at Week 16
Time to loss of EASI 50 response in Period 2 relative to Baseline among those who were re-randomized as EASI 75 responders at Week 16.
Time to loss of EASI 50 response was measured from Week 16 to the date of the first assessment in Period 2 where a participant's EASI score was higher than 50% of their Baseline score.
Participants with no loss of response were censored at their last treatment visit or the start of rescue treatment, whichever occurred first.
From re-randomization at Week 16 until Week 88
Percentage of Participants With an EASI 75 Response in Period 2 in Participants Who Were Re-randomized as EASI 75 Non-responders at Week 16
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.
An EASI 75 response is defined as at least a 75% reduction (improvement) in EASI score relative to the Baseline value, and was analyzed in participants who were re-randomized at Week 16 and were EASI 75 non-responders at Week 16.
Weeks 20, 24, 32, 40, 52, 64, 76, and 88
Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) of "0" or "1" at Weeks 8 and 16
The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A score of 0 or 1 means that the disease has no effect at all.
Dermatology Life Quality Index outcomes were defined but are not reported because of an error in the programming of the electronic device used to administer the questionnaire that precluded determination of these outcomes.
Weeks 8 and 16
Change From Baseline in DLQI at Weeks 8 and 16
The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A negative change from Baseline indicates improvement.
Dermatology Life Quality Index outcomes were defined but are not reported because of an error in the programming of the electronic device used to administer the questionnaire that precluded determination of these outcomes.
Baseline and Weeks 8 and 16
Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16
Body surface area (BSA) affected by atopic dermatitis was assessed by the physician and is expressed as a percentage of the total BSA. For purposes of the estimation, the total surface of the participant's palm plus five digits was assumed to be approximately equivalent to 1% BSA.
Last observation carried forward imputation was used.
Baseline and Week 16
Percentage of Participants With Reduction of ≥ 4 Points From Baseline in Pruritus NRS at Week 16
Participants were asked to rate pruritus (itch) in the past 24 hours on a daily basis using a scale from 0 to 10, with 0 being no itch and 10 being the worst imaginable itch. The percentage of participants with reduction of ≥ 4 points from Baseline in pruritus NRS was assessed in participants with a baseline pruritus NRS of ≥ 4. Participants with missing values at Week 16 were counted as non-responders in this analysis (non-responder imputation).
Baseline and Week 16
Sandy Springs
Georgia
30328-6141
United States
DermAssociates /ID# 153584
Rockville
Maryland
20850
United States
Tufts Medical Center /ID# 153586
Boston
Massachusetts
02111
United States
Psoriasis Treatment Ctr NJ /ID# 153578
East Windsor
New Jersey
08520
United States
Icahn School of Med Mt. Sinai /ID# 153582
New York
New York
10029
United States
Univ Rochester Med Ctr /ID# 154477
Rochester
New York
14642
United States
Arlington Research Center, Inc /ID# 154522
Arlington
Texas
76011
United States
Modern Research Associates, PL /ID# 154487
Dallas
Texas
75231
United States
Center for Clinical Studies /ID# 153589
Houston
Texas
77004
United States
Woden Dermatology /ID# 157907
Phillip
Australian Capital Territory
2606
Australia
St George Hospital /ID# 157908
Kogarah
New South Wales
2217
Australia
Specialist Connect Pty Ltd /ID# 157909
Woolloongabba
Queensland
4102
Australia
Skin Health Institute Inc /ID# 157906
Carlton
Victoria
3053
Australia
Institute for Skin Advancement /ID# 153246
Calgary
Alberta
T3A 2N1
Canada
Dr. Chih-ho Hong Medical Inc. /ID# 153241
Surrey
British Columbia
V3R 6A7
Canada
Enverus Medical Research /ID# 153239
Surrey
British Columbia
V3V 0C6
Canada
CCA Medical Research /ID# 155817
Ajax
Ontario
L1S 7K8
Canada
Lynderm Research Inc. /ID# 153242
Markham
Ontario
L3P 1X2
Canada
Dermatology Ottawa Research Centre /ID# 153248
Ottawa
Ontario
K2C 3N2
Canada
K. Papp Clinical Research /ID# 153244
Waterloo
Ontario
N2J 1C4
Canada
Mehiläinen Neo /ID# 154960
Turku
Southwest Finland
20520
Finland
Mikkeli Central Hospital /ID# 154959
Mikkeli
50100
Finland
TFS Trial Form Support GmbH /ID# 155442
Hamburg
20354
Germany
Fukuoka University Hospital /ID# 152714
Fukuoka
Fukuoka
814-0180
Japan
Takagi Dermatological Clinic /ID# 152706
Obihiro-shi
Hokkaido
080-0013
Japan
Medical Cooperation Kojinkai Sapporo Skin Clinic /ID# 153781
Sapporo
Hokkaido
060-0063
Japan
Nippon Medical School Hospital /ID# 153287
Tokyo
113-8602
Japan
Radboud Universitair Medisch Centrum /ID# 153688
Nijmegen
Gelderland
6525 GA
Netherlands
Academisch Medisch Centrum /ID# 153596
Amsterdam
North Holland
1105 AZ
Netherlands
Universitair Medisch Centrum Groningen /ID# 153595
Groningen
9713 GZ
Netherlands
Universitair Medisch Centrum Utrecht /ID# 153687
Utrecht
3584 CX
Netherlands
Hospital Santa Creu i Sant Pau /ID# 153519
Barcelona
08026
Spain
Hospital Univ Germans Trias I /ID# 155598
Barcelona
08916
Spain
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 7.5 mg upadacitinib or placebo QD for 72 weeks in Period 2.
FG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 15 mg upadacitinib or placebo QD for 72 weeks in Period 2.
FG003
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 30 mg upadacitinib or placebo QD for 72 weeks in Period 2.
FG004
Placebo / Placebo
Participants originally randomized to placebo were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
FG005
Placebo / Upadacitinib 30 mg
Participants originally randomized to placebo were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
FG006
Upadacitinib 7.5 mg / Placebo
Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
FG007
Upadacitinib 7.5 mg / Upadacitinib 7.5 mg
Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive 7.5 mg upadacitinib once a day for 72 weeks in Period 2.
FG008
Upadacitinib 15 mg / Placebo
Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
FG009
Upadacitinib 15 mg / Upadacitinib 15 mg
Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive 15 mg upadacitinib once a day for 72 weeks in Period 2.
FG010
Upadacitinib 30 mg / Placebo
Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
FG011
Upadacitinib 30 mg / Upadacitinib 30 mg
Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
FG00041 subjects
FG00142 subjects
FG00242 subjects
FG00342 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Received Treatment
FG00040 subjects
FG00142 subjects
FG00242 subjects
FG00342 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG00023 subjects
FG00131 subjects
FG00237 subjects
FG00339 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG00018 subjects
FG00111 subjects
FG0025 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0013 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Withdrawal by Subject
FG00010 subjects
FG0013 subjects
FG0023 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0005 subjects
FG0014 subjects
FG0021 subjects
FG0031 subjects
FG004
Period 2 (Weeks 16 - 88)
Type
Comment
Milestone Data
STARTED
Four participants completed Week 16 but were not re-randomized into Period 2.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00410 subjects
FG00510 subjects
FG00615 subjects
FG00716 subjects
FG00819 subjects
FG00918 subjects
FG01019 subjects
FG01119 subjects
Rescued to Upadacitinib 30 mg
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All randomized participants (intent-to-treat population)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
BG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
BG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
BG003
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00041
BG00142
BG00242
BG00342
BG004167
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG00041
ParticipantsBG00142
ParticipantsBG00242
ParticipantsBG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00041
ParticipantsBG00142
ParticipantsBG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00041
ParticipantsBG00142
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00041
ParticipantsBG00142
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00041
ParticipantsBG00142
ParticipantsBG002
Geographic Region
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00041
ParticipantsBG00142
ParticipantsBG002
Duration of Atopic Dermatitis Diagnosis
Participants with available data
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG00040
ParticipantsBG00142
ParticipantsBG002
Eczema Area and Severity Index (EASI)
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
units on a scale
Title
Denominators
Categories
ParticipantsBG00041
ParticipantsBG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percent Change From Baseline in Eczema Area and Severity Index (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.
Randomized participants with at least one post-baseline EASI assessment; last observation carried forward (LOCF) imputation was used.
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Week 16
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
OG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
OG003
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Units
Counts
Participants
OG00039
OG00142
OG00242
OG003
Title
Denominators
Categories
Title
Measurements
OG000-23.0± 6.42
OG001-39.4± 6.24
OG002-61.7± 6.12
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
ANCOVA
Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.
< 0.001
Least Squares (LS) Mean Difference
-51.4
Standard Error of the Mean
7.65
2-Sided
95
-66.5
-36.3
Superiority
OG000
OG002
Secondary
Percentage of Participants Who Achieved a 75% Reduction in EASI Score (EASI 75) at Week 16
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.
An EASI 75 response is defined as participants with at least a 75% reduction (improvement) in EASI score relative to the Baseline value.
Participants with missing values at Week 16 were counted as non-responders in this analysis (non-responder imputation).
All randomized participants; non-responder imputation was used.
Posted
Number
percentage of participants
Baseline and Week 16
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
OG002
Upadacitinib 15 mg
Secondary
Percentage of Participants Achieving an Investigator Global Assessment (IGA) of "0" or "1" at Week 16
The Investigator's Global Assessment for Atopic Dermatitis (IGA) was scored on the following scale:
0: Clear (No inflammatory signs of atopic dermatitis)
1: Almost Clear (Just perceptible erythema and just perceptible papulation/infiltration)
2: Mild (Mild erythema and mild papulation/infiltration)
3: Moderate (Moderate erythema and moderate papulation/infiltration)
4: Severe (Severe erythema and severe papulation/infiltration with or without oozing/crusting)
The percentage of participants with a score of 0 or 1 at Week 16 is reported.
All randomized participants; non-responder imputation was used.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
OG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
Secondary
Percent Change From Baseline to Weeks 2, 8, and 16 in Pruritus Numerical Rating Scale (NRS)
Participants were asked to rate pruritus (itch) in the past 24 hours on a daily basis using a scale from 0 to 10, with 0 being no itch and 10 being the worst imaginable itch. The percent change from Baseline at each week was calculated from a rolling weekly average.
Randomized participants with a Baseline and at least one post-baseline measurement; last observation carried forward (LOCF) imputation was used.
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Weeks 2, 8, and 16
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
OG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
OG003
Upadacitinib 30 mg
Secondary
Percent Change From Baseline in EASI Score at Week 8
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.
Randomized participants with at least one post-baseline measurement; Last observation carried forward (LOCF) imputation was used.
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Week 8
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Secondary
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Weeks 8 and 16
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.
Randomized participants with Baseline and at least one post-baseline measurement; Last observation carried forward imputation was used.
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Weeks 8 and 16
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
OG002
Upadacitinib 15 mg
Secondary
Percentage of Participants Who Achieved an EASI 75 Response at Week 8
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.
An EASI 75 response is defined as participants with at least a 75% reduction (improvement) in EASI score relative to the Baseline value.
Participants with missing values at Week 8 were counted as non-responders in this analysis (non-responder imputation).
All randomized participants; Non-responder imputation was used.
Posted
Number
percentage of participants
Baseline and Week 8
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
OG002
Upadacitinib 15 mg
Secondary
Percentage of Participants Who Achieved an EASI 50 Response at Weeks 8 and 16
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.
An EASI 50 response is defined as participants with at least a 50% reduction (improvement) in EASI score relative to the Baseline value.
Participants with missing values at each time point were counted as non-responders in this analysis (non-responder imputation).
All randomized participants; non-responder imputation was used.
Posted
Number
percentage of participants
Baseline and Weeks 8 and 16
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
OG002
Upadacitinib 15 mg
Secondary
Percentage of Participants Who Achieved an EASI 90 Response at Weeks 8 and 16
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.
An EASI 90 response is defined as participants with at least a 90% reduction (improvement) in EASI score relative to the Baseline value.
Participants with missing values at each time point were counted as non-responders in this analysis (non-responder imputation).
All randomized participants; non-responder imputation was used.
Posted
Number
percentage of participants
Baseline and Weeks 8 and 16
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
OG002
Upadacitinib 15 mg
Secondary
Percentage of Participants Who Achieved a SCORAD 50 Response at Weeks 8 and 16
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).
A SCORAD 50 response is defined as participants with at least a 50% reduction (improvement) in SCORAD score relative to the Baseline value.
Participants with missing values were counted as non-responders in this analysis (non-responder imputation).
All randomized participants; non-responder imputation was used.
Posted
Number
percentage of participants
Baseline and Weeks 8 and 16
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Secondary
Percentage of Participants Who Achieved a SCORAD 75 Response at Weeks 8 and 16
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).
A SCORAD 75 response is defined as participants with at least a 75% reduction (improvement) in SCORAD score relative to the Baseline value.
Participants with missing values were counted as non-responders in this analysis (non-responder imputation).
All randomized participants; Non-responder imputation was used.
Posted
Number
percentage of participants
Baseline and Weeks 8 and 16
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Secondary
Percentage of Participants Who Achieved a SCORAD 90 Response at Weeks 8 and 16
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).
A SCORAD 90 response is defined as participants with at least a 90% reduction (improvement) in SCORAD score relative to the Baseline value.
Participants with missing values were counted as non-responders in this analysis (non-responder imputation).
All randomized participants; non-responder imputation was used.
Posted
Number
percentage of participants
Baseline and Weeks 8 and 16
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Secondary
Percent Change From Re-randomization (Week 16) in EASI Score in Period 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; a negative change from Baseline indicates improvement.
Participants who were re-randomized at the entry of Period 2 (Week 16) with at least one post-Week 16 assessment; Last observation carried forward (LOCF) imputation was used.
Posted
Least Squares Mean
Standard Error
percent change
Re-randomization (Week 16) and Weeks 20, 24, 32, 40, 52, 64, 76, and 88
ID
Title
Description
OG000
Placebo / Placebo
Participants originally randomized to placebo were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
OG001
Placebo / Upadacitinib 30 mg
Secondary
Time to Loss of EASI 50 Response Relative to Baseline Among Participants Re-randomized as EASI 75 Responders at Week 16
Time to loss of EASI 50 response in Period 2 relative to Baseline among those who were re-randomized as EASI 75 responders at Week 16.
Time to loss of EASI 50 response was measured from Week 16 to the date of the first assessment in Period 2 where a participant's EASI score was higher than 50% of their Baseline score.
Participants with no loss of response were censored at their last treatment visit or the start of rescue treatment, whichever occurred first.
Participants who were re-randomized as EASI 75 responders at Week 16.
Posted
Median
95% Confidence Interval
days
From re-randomization at Week 16 until Week 88
ID
Title
Description
OG000
Placebo / Placebo
Participants originally randomized to placebo were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
OG001
Placebo / Upadacitinib 30 mg
Participants originally randomized to placebo were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
OG002
Upadacitinib 7.5 mg / Placebo
Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
Secondary
Percentage of Participants With an EASI 75 Response in Period 2 in Participants Who Were Re-randomized as EASI 75 Non-responders at Week 16
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.
An EASI 75 response is defined as at least a 75% reduction (improvement) in EASI score relative to the Baseline value, and was analyzed in participants who were re-randomized at Week 16 and were EASI 75 non-responders at Week 16.
Participants who were re-randomized at Week 16 and were EASI 75 non-responders at Week 16, and with available data at each time point.
Posted
Number
percentage of participants
Weeks 20, 24, 32, 40, 52, 64, 76, and 88
ID
Title
Description
OG000
Placebo / Placebo
Participants originally randomized to placebo were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
OG001
Placebo / Upadacitinib 30 mg
Participants originally randomized to placebo were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
Secondary
Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) of "0" or "1" at Weeks 8 and 16
The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A score of 0 or 1 means that the disease has no effect at all.
Dermatology Life Quality Index outcomes were defined but are not reported because of an error in the programming of the electronic device used to administer the questionnaire that precluded determination of these outcomes.
Due to an error in the electronic device used to administer the questionnaire data were not available for any participants
Posted
Weeks 8 and 16
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
OG002
Secondary
Change From Baseline in DLQI at Weeks 8 and 16
The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A negative change from Baseline indicates improvement.
Dermatology Life Quality Index outcomes were defined but are not reported because of an error in the programming of the electronic device used to administer the questionnaire that precluded determination of these outcomes.
Due to an error in the electronic device used to administer the questionnaire data were not available for any participants.
Posted
Baseline and Weeks 8 and 16
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
OG002
Upadacitinib 15 mg
Secondary
Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16
Body surface area (BSA) affected by atopic dermatitis was assessed by the physician and is expressed as a percentage of the total BSA. For purposes of the estimation, the total surface of the participant's palm plus five digits was assumed to be approximately equivalent to 1% BSA.
Last observation carried forward imputation was used.
Randomized participants with at least one post-baseline measurement; Last observation carried forward (LOCF) imputation was used.
Posted
Least Squares Mean
Standard Error
percentage of body surface area
Baseline and Week 16
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
OG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
OG003
Upadacitinib 30 mg
Secondary
Percentage of Participants With Reduction of ≥ 4 Points From Baseline in Pruritus NRS at Week 16
Participants were asked to rate pruritus (itch) in the past 24 hours on a daily basis using a scale from 0 to 10, with 0 being no itch and 10 being the worst imaginable itch. The percentage of participants with reduction of ≥ 4 points from Baseline in pruritus NRS was assessed in participants with a baseline pruritus NRS of ≥ 4. Participants with missing values at Week 16 were counted as non-responders in this analysis (non-responder imputation).
Randomized participants with Baseline pruritus NRS of ≥ 4; non-responder imputation was used.
Posted
Number
percentage of participants
Baseline and Week 16
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
OG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
OG003
Time Frame
From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
Description
Any adverse event that occurred on or after the first dose of upadacitinib 30 mg rescue therapy in Period 2 is counted in the Period 1+2: Upadacitinib 30 mg group. Participants who received rescue therapy after placebo, upadacitinib 7.5 mg or 15 mg treatment in Period 2 are counted in the denominators of both Period 1+2: Placebo/Upadacitinib 7.5 mg/15 mg and Period 1+2: Upadacitinib 30 mg dose groups.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Period 1: Placebo
Participants received placebo once daily (QD) for 16 weeks in Period 1.
0
40
1
40
15
40
EG001
Period 1: Upadacitinib 7.5 mg
Participants received upadacitinib 7.5 mg once daily for 16 weeks in Period 1
0
42
2
42
21
42
EG002
Period 1: Upadacitinib 15 mg
Participants received upadacitinib 15 mg once daily for 16 weeks in Period 1.
0
42
1
42
17
42
EG003
Period 1: Upadacitinib 30 mg
Participants received upadacitinib 30 mg once daily for 16 weeks in Period 1.
0
42
0
42
21
42
EG004
Period 1+2: Upadacitinib 7.5 mg
Participants originally randomized to upadacitinib 7.5 mg received upadacitinib 7.5 mg once daily for 16 weeks in Period 1; Participants re-randomized to upadacitinib 7.5 mg in Period 2 continued to receive upadacitinib 7.5 mg for 72 weeks in Period 2 or until rescue.
0
42
2
42
23
42
EG005
Period 1+2: Upadacitinib 15 mg
Participants originally randomized to upadacitinib 15 mg received upadacitinib 15 mg once daily for 16 weeks in Period 1; Participants re-randomized to upadacitinib 15 mg in Period 2 continued to receive upadacitinib 15 mg for 72 weeks in Period 2 or until rescue.
0
42
1
42
22
42
EG006
Period 1+2: Upadacitinib 30 mg
Participants originally randomized to upadacitinib 30 mg received upadacitinib 30 mg once daily for 16 weeks in Period 1. Participants re-randomized to upadacitinib 30 mg in Period 2 continued to receive upadacitinib 30 mg for 72 weeks in Period 2.
Participants originally randomized to placebo and re-randomized to upadacitinib 30 mg at Week 16 received upadacitinib 30 mg from Week 16 to Week 88.
Participants re-randomized to placebo, upadacitinib 7.5 mg or 15 mg at Week 16 who were rescued starting at Week 20 or later received upadacitinib 30 mg until Week 88.
2
114
7
114
68
114
EG007
Period 1+2: Placebo
Participants originally randomized to placebo received placebo once daily for 16 weeks in Period 1.
Participants re-randomized to placebo in Period 2 continued to receive placebo for 72 weeks in Period 2 or until rescue.
0
93
1
93
19
93
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG0030 events0 affected42 at risk
EG0040 events0 affected42 at risk
EG0050 events0 affected42 at risk
EG0060 events0 affected114 at risk
EG0071 events1 affected93 at risk
CARDIO-RESPIRATORY ARREST
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
PERICARDITIS
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
OESOPHAGEAL FISTULA
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
APPENDICITIS
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
PERICORONITIS
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
SEPSIS
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
SKIN INFECTION
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
ROTATOR CUFF SYNDROME
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
SQUAMOUS CELL CARCINOMA OF SKIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
URETEROLITHIASIS
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
DERMATITIS ATOPIC
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
DIARRHOEA
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0012 events2 affected42 at risk
EG0024 events2 affected42 at risk
EG0030 events0 affected42 at risk
EG0042 events2 affected42 at risk
EG0055 events2 affected42 at risk
EG0062 events2 affected114 at risk
EG0072 events2 affected93 at risk
NAUSEA
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0013 events3 affected42 at risk
EG0021 events1 affected42 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
IMPETIGO
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0013 events3 affected42 at risk
EG0020 events0 affected42 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0012 events2 affected42 at risk
EG0025 events4 affected42 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0004 events4 affected40 at risk
EG0017 events7 affected42 at risk
EG0025 events5 affected42 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected42 at risk
EG0022 events2 affected42 at risk
EG003
LIGAMENT SPRAIN
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
BLOOD CREATINE PHOSPHOKINASE INCREASED
Investigations
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected42 at risk
EG0023 events3 affected42 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0013 events3 affected42 at risk
EG0023 events3 affected42 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
PROTEINURIA
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0013 events3 affected42 at risk
EG0020 events0 affected42 at risk
EG003
ACNE
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0016 events4 affected42 at risk
EG0022 events2 affected42 at risk
EG003
DERMATITIS ATOPIC
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0016 events5 affected42 at risk
EG0022 events2 affected42 at risk
EG003
DERMATITIS CONTACT
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
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
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000613732
upadacitinib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
8 subjects
FG0051 subjects
FG00613 subjects
FG00712 subjects
FG00817 subjects
FG00912 subjects
FG01014 subjects
FG0114 subjects
8 subjects
FG0055 subjects
FG0069 subjects
FG00711 subjects
FG00813 subjects
FG00912 subjects
FG01011 subjects
FG01114 subjects
2 subjects
FG0055 subjects
FG0066 subjects
FG0075 subjects
FG0086 subjects
FG0096 subjects
FG0108 subjects
FG0115 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0103 subjects
FG0112 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0064 subjects
FG0073 subjects
FG0082 subjects
FG0092 subjects
FG0102 subjects
FG0112 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0052 subjects
FG0061 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0083 subjects
FG0094 subjects
FG0103 subjects
FG0110 subjects
42
ParticipantsBG004167
Title
Measurements
BG00039.9± 17.52
BG00141.5± 15.36
BG00238.5± 15.24
BG00339.9± 15.30
BG00439.9± 15.77
42
ParticipantsBG00342
ParticipantsBG004167
Title
Measurements
< 40 years
BG00025
BG00122
BG00225
BG00322
BG00494
40 - 64 years
BG00011
BG00116
BG00214
BG00317
BG004
≥ 65 years
BG0005
BG0014
BG0023
BG0033
BG004
42
ParticipantsBG00342
ParticipantsBG004167
Title
Measurements
Female
BG00017
BG00114
BG00212
BG00320
BG00463
Male
BG00024
BG00128
BG00230
BG00322
BG004
42
ParticipantsBG00342
ParticipantsBG004167
Title
Measurements
Hispanic or Latino
BG0000
BG0012
BG0022
BG0031
BG0045
Not Hispanic or Latino
BG00041
BG00140
BG00240
BG00341
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
42
ParticipantsBG00342
ParticipantsBG004167
Title
Measurements
White
BG00028
BG00124
BG00221
BG00323
BG00496
Black or African American
BG0006
BG0017
BG00210
BG0036
BG004
Asian
BG0007
BG0019
BG0029
BG00313
BG004
American Indian/Alaska Native
BG0000
BG0010
BG0021
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0012
BG0021
BG0030
BG004
42
ParticipantsBG00342
ParticipantsBG004167
Title
Measurements
US/Canada
BG00029
BG00129
BG00229
BG00329
BG004116
EU/Australia
BG00010
BG00111
BG00210
BG00310
BG004
Japan
BG0002
BG0012
BG0023
BG0033
BG004
42
ParticipantsBG00342
ParticipantsBG004166
Title
Measurements
BG00026.84± 18.76
BG00130.44± 18.07
BG00222.59± 15.78
BG00324.24± 13.58
BG00426.02± 16.76
42
ParticipantsBG00242
ParticipantsBG00342
ParticipantsBG004167
Title
Measurements
BG00032.62± 14.49
BG00131.42± 15.76
BG00231.40± 12.26
BG00328.15± 11.62
BG00430.89± 13.61
42
-74.4
± 6.13
ANCOVA
Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.
<0.001
LS Mean Difference
-38.7
Standard Error of the Mean
7.61
2-Sided
95
-53.7
-23.6
Superiority
OG000
OG001
ANCOVA
Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.
0.032
LS Mean Difference
-16.4
Standard Error of the Mean
7.61
2-Sided
95
-31.4
-1.4
Superiority
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
OG003
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Units
Counts
Participants
OG00041
OG00142
OG00242
OG00342
Title
Denominators
Categories
Title
Measurements
OG0009.8
OG00128.6
OG00252.4
OG00369.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).
< 0.001
Adjusted Difference
58.7
2-Sided
95
42.5
74.8
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).
<0.001
Adjusted Difference
42.5
2-Sided
95
25.5
59.6
Superiority
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).
0.022
Adjusted Difference
18.7
2-Sided
95
2.7
34.7
Superiority
OG003
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Units
Counts
Participants
OG00041
OG00142
OG00242
OG00342
Title
Denominators
Categories
Title
Measurements
OG0002.4
OG00114.3
OG00231.0
OG00350.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).
<0.001
Adjusted Difference
46.9
2-Sided
95
31.1
62.7
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).
<0.001
Adjusted Difference
28.6
2-Sided
95
13.8
43.4
Superiority
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).
0.044
Adjusted Difference
11.9
2-Sided
95
0.3
23.5
Superiority
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Units
Counts
Participants
OG00037
OG00140
OG00237
OG00342
Title
Denominators
Categories
Week 2
ParticipantsOG00037
ParticipantsOG00139
ParticipantsOG00237
ParticipantsOG00342
Title
Measurements
OG0001.7± 5.59
OG001-29.3± 5.45
OG002-46.0± 5.44
OG003
Week 8
ParticipantsOG00037
ParticipantsOG00140
ParticipantsOG00237
ParticipantsOG00342
Week 16
ParticipantsOG00037
ParticipantsOG00140
ParticipantsOG00237
ParticipantsOG00342
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Analysis of Percent Change from Baseline in Pruritus NRS at Week 2
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
<0.001
LS Mean Difference
-59.3
Standard Error of the Mean
6.58
2-Sided
95
-72.3
-46.3
Superiority
OG000
OG002
Analysis of Percent Change from Baseline in Pruritus NRS at Week 2
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
<0.001
LS Mean Difference
-47.7
Standard Error of the Mean
6.78
2-Sided
95
-61.1
-34.3
Superiority
OG000
OG001
Analysis of Percent Change from Baseline in Pruritus NRS at Week 2
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
<0.001
LS Mean Difference
-31.1
Standard Error of the Mean
6.7
2-Sided
95
-44.3
-17.8
Superiority
OG000
OG003
Analysis of Percent Change from Baseline in Pruritus NRS at Week 8
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
<0.001
LS Mean Difference
-66.4
Standard Error of the Mean
8.85
2-Sided
95
-83.9
-48.9
Superiority
OG000
OG002
Analysis of Percent Change from Baseline in Pruritus NRS at Week 8
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
<0.001
LS Mean Difference
-38.4
Standard Error of the Mean
9.13
2-Sided
95
-56.4
-20.4
Superiority
OG000
OG001
Analysis of Percent Change from Baseline in Pruritus NRS at Week 8
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
0.002
LS Mean Difference
-28.9
Standard Error of the Mean
8.96
2-Sided
95
-46.6
-11.2
Superiority
OG000
OG003
Analysis of Percent Change from Baseline in Pruritus NRS at Week 16
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
<0.001
LS Mean Difference
-59.2
Standard Error of the Mean
9.78
2-Sided
95
-78.6
-39.9
Superiority
OG000
OG002
Analysis of Percent Change from Baseline in Pruritus NRS at Week 16
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
<0.001
LS Mean Difference
-38.3
Standard Error of the Mean
10.08
2-Sided
95
-58.3
-18.4
Superiority
OG000
OG001
Analysis of Percent Change from Baseline in Pruritus NRS at Week 16
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
0.003
LS Mean Difference
-29.9
Standard Error of the Mean
9.90
2-Sided
95
-49.4
-10.3
Superiority
OG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
OG003
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Units
Counts
Participants
OG00039
OG00142
OG00242
OG00342
Title
Denominators
Categories
Title
Measurements
OG000-17.5± 6.27
OG001-43.7± 6.09
OG002-65.4± 5.97
OG003-82.8± 5.98
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
<0.001
LS Mean Difference
-65.3
Standard Error of the Mean
7.46
2-Sided
95
-80.0
-50.5
Superiority
OG000
OG002
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
<0.001
LS Mean Difference
-47.9
Standard Error of the Mean
7.42
2-Sided
95
-62.6
-33.3
Superiority
OG000
OG001
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
<0.001
LS Mean Difference
-26.2
Standard Error of the Mean
7.42
2-Sided
95
-40.8
-11.5
Superiority
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
OG003
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Units
Counts
Participants
OG00033
OG00139
OG00236
OG00340
Title
Denominators
Categories
Week 8
Title
Measurements
OG000-7.0± 5.84
OG001-35.4± 5.53
OG002-44.1± 5.69
OG003-65.3± 5.52
Week 16
Title
Measurements
OG000-12.4± 5.97
OG001-32.5± 5.66
OG002-46.9± 5.82
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Analysis of Percent Change from Baseline in SCORAD at Week 8
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
<0.001
LS Mean Difference
-58.3
Standard Error of the Mean
6.78
2-Sided
95
-71.7
-44.9
Superiority
OG000
OG002
Analysis of Percent Change from Baseline in SCORAD at Week 8
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
<0.001
LS Mean Difference
-37.1
Standard Error of the Mean
6.94
2-Sided
95
-50.8
-23.4
Superiority
OG000
OG001
Analysis of Percent Change from Baseline in SCORAD at Week 8
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
<0.001
LS Mean Difference
-28.4
Standard Error of the Mean
6.81
2-Sided
95
-41.9
-15.0
Superiority
OG000
OG003
Analysis of Percent Change from Baseline in SCORAD at Week 16
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
<0.001
LS Mean Difference
-48.0
Standard Error of the Mean
6.93
2-Sided
95
-61.7
-34.3
Superiority
OG000
OG002
Analysis of Percent Change from Baseline in SCORAD at Week 16
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
<0.001
LS Mean Difference
-34.5
Standard Error of the Mean
7.10
2-Sided
95
-48.5
-20.5
Superiority
OG000
OG001
Analysis of Percent Change from Baseline in SCORAD at Week 16
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
0.004
LS Mean Difference
-20.2
Standard Error of the Mean
6.96
2-Sided
95
-33.9
-6.4
Superiority
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
OG003
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Units
Counts
Participants
OG00041
OG00142
OG00242
OG00342
Title
Denominators
Categories
Title
Measurements
OG0007.3
OG00131.0
OG00252.4
OG00381.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
72.7
2-Sided
95
58.3
87.1
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
44.9
2-Sided
95
27.9
61.9
Superiority
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
0.004
Adjusted Difference
23.4
2-Sided
95
7.5
39.4
Superiority
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
OG003
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Units
Counts
Participants
OG00041
OG00142
OG00242
OG00342
Title
Denominators
Categories
Week 8
Title
Measurements
OG00022.0
OG00154.8
OG00271.4
OG00392.9
Week 16
Title
Measurements
OG00022.0
OG00150.0
OG00271.4
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Analysis of EASI 50 Response at Week 8
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
70.7
2-Sided
95
56.2
85.2
Superiority
OG000
OG002
Analysis of EASI 50 Response at Week 8
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
49.0
2-Sided
95
30.8
67.3
Superiority
OG000
OG001
Analysis of EASI 50 Response at Week 8
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
32.8
2-Sided
95
13.4
52.2
Superiority
OG000
OG003
Analysis of EASI 50 Response at Week 16
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
60.6
2-Sided
95
45.3
75.9
Superiority
OG000
OG002
Analysis of EASI 50 Response at Week 16
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
48.6
2-Sided
95
31.3
65.9
Superiority
OG000
OG001
Analysis of EASI 50 Response at Week 16
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
0.003
Adjusted Difference
28.2
2-Sided
95
9.8
46.6
Superiority
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
OG003
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Units
Counts
Participants
OG00041
OG00142
OG00242
OG00342
Title
Denominators
Categories
Week 8
Title
Measurements
OG0000.0
OG0019.5
OG00226.2
OG00345.2
Week 16
Title
Measurements
OG0002.4
OG00114.3
OG00226.2
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Analysis of EASI 90 Response at Week 8
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
43.8
2-Sided
95
29.1
58.5
Superiority
OG000
OG002
Analysis of EASI 90 Response at Week 8
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
26.1
2-Sided
95
12.6
39.6
Superiority
OG000
OG001
Analysis of EASI 90 Response at Week 8
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
0.051
Adjusted Difference
9.4
2-Sided
95
-0.0
18.8
Superiority
OG000
OG003
Analysis of EASI 90 Response at Week 16
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
46.9
2-Sided
95
31.3
62.4
Superiority
OG000
OG002
Analysis of EASI 90 Response at Week 16
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
0.001
Adjusted Difference
23.8
2-Sided
95
9.6
38.1
Superiority
OG000
OG001
Analysis of EASI 90 Response at Week 16
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
0.049
Adjusted Difference
11.8
2-Sided
95
0.1
23.6
Superiority
OG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
OG003
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Units
Counts
Participants
OG00041
OG00142
OG00242
OG00342
Title
Denominators
Categories
Week 8
Title
Measurements
OG0007.3
OG00133.3
OG00242.9
OG00376.2
Week 16
Title
Measurements
OG0007.3
OG00128.6
OG00242.9
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Analysis of SCORAD 50 Response at Week 8
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
68.4
2-Sided
95
54.0
82.8
Superiority
OG000
OG002
Analysis of SCORAD 50 Response at Week 8
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
35.3
2-Sided
95
18.5
52.2
Superiority
OG000
OG001
Analysis of SCORAD 50 Response at Week 8
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
0.002
Adjusted Difference
25.7
2-Sided
95
9.6
41.7
Superiority
OG000
OG003
Analysis of SCORAD 50 Response at Week 16
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
54.5
2-Sided
95
39.0
69.9
Superiority
OG000
OG002
Analysis of SCORAD 50 Response at Week 16
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
35.8
2-Sided
95
19.1
52.5
Superiority
OG000
OG001
Analysis of SCORAD 50 Response at Week 16
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
0.008
Adjusted Difference
21.2
2-Sided
95
5.7
36.8
Superiority
OG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
OG003
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Units
Counts
Participants
OG00041
OG00142
OG00242
OG00342
Title
Denominators
Categories
Week 8
Title
Measurements
OG0000.0
OG0019.5
OG0029.5
OG00331.0
Week 16
Title
Measurements
OG0002.4
OG0014.8
OG00221.4
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Analysis of SCORAD 75 Response at Week 8
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
30.4
2-Sided
95
16.2
44.6
Superiority
OG000
OG002
Analysis of SCORAD 75 Response at Week 8
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
0.052
Adjusted Difference
9.4
2-Sided
95
-0.1
18.9
Superiority
OG000
OG001
Analysis of SCORAD 75 Response at Week 8
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
0.048
Adjusted Difference
9.3
2-Sided
95
0.1
18.5
Superiority
OG000
OG003
Analysis of SCORAD 75 Response at Week 16
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
37.7
2-Sided
95
22.2
53.3
Superiority
OG000
OG002
Analysis of SCORAD 75 Response at Week 16
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
0.006
Adjusted Difference
19.0
2-Sided
95
5.6
32.5
Superiority
OG000
OG001
Analysis of SCORAD 75 Response at Week 16
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
0.581
Adjusted Difference
2.4
2-Sided
95
-6.0
10.8
Superiority
OG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
OG003
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Units
Counts
Participants
OG00041
OG00142
OG00242
OG00342
Title
Denominators
Categories
Week 8
Title
Measurements
OG0000.0
OG0014.8
OG0022.4
OG00314.3
Week 16
Title
Measurements
OG0000.0
OG0012.4
OG0029.5
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Analysis of SCORAD 90 Response at Week 8
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
0.012
Adjusted Difference
14.2
2-Sided
95
3.2
25.2
Superiority
OG000
OG002
Analysis of SCORAD 90 Response at Week 8
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
0.428
Adjusted Difference
2.3
2-Sided
95
-3.4
8.0
Superiority
OG000
OG001
Analysis of SCORAD 90 Response at Week 8
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
0.206
Adjusted Difference
4.6
2-Sided
95
-2.5
11.8
Superiority
OG000
OG003
Analysis of SCORAD 90 Response at Week 16
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
23.3
2-Sided
95
10.4
36.2
Superiority
OG000
OG002
Analysis of SCORAD 90 Response at Week 16
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
0.048
Adjusted Difference
9.4
2-Sided
95
0.1
18.8
Superiority
OG000
OG001
Analysis of SCORAD 90 Response at Week 16
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
0.426
Adjusted Difference
2.4
2-Sided
95
-3.4
8.1
Superiority
Participants originally randomized to placebo were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
OG002
Upadacitinib 7.5 mg / Placebo
Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
OG003
Upadacitinib 7.5 mg / Upadacitinib 7.5 mg
Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive 7.5 mg upadacitinib once a day for 72 weeks in Period 2.
OG004
Upadacitinib 15 mg / Placebo
Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
OG005
Upadacitinib 15 mg / Upadacitinib 15 mg
Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive 15 mg upadacitinib once a day for 72 weeks in Period 2.
OG006
Upadacitinib 30 mg / Placebo
Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
OG007
Upadacitinib 30 mg / Upadacitinib 30 mg
Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
Units
Counts
Participants
OG00010
OG00110
OG00215
OG00315
OG00417
OG00518
OG00614
OG00719
Title
Denominators
Categories
Week 20
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00215
ParticipantsOG00315
ParticipantsOG00417
ParticipantsOG00516
ParticipantsOG00613
ParticipantsOG00718
Title
Measurements
OG00050.7± 33.50
OG00111.8± 30.59
OG002186.0± 46.53
OG003
Week 24
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00215
ParticipantsOG00315
Week 32
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00215
ParticipantsOG00315
Week 40
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00215
ParticipantsOG00315
Week 52
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00215
ParticipantsOG00315
Week 64
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00215
ParticipantsOG00315
Week 76
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00215
ParticipantsOG00315
Week 88
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00215
ParticipantsOG00315
OG003
Upadacitinib 7.5 mg / Upadacitinib 7.5 mg
Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive 7.5 mg upadacitinib once a day for 72 weeks in Period 2.
OG004
Upadacitinib 15 mg / Placebo
Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
OG005
Upadacitinib 15 mg / Upadacitinib 15 mg
Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive 15 mg upadacitinib once a day for 72 weeks in Period 2.
OG006
Upadacitinib 30 mg / Placebo
Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
OG007
Upadacitinib 30 mg / Upadacitinib 30 mg
Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
Units
Counts
Participants
OG0001
OG0012
OG0025
OG0035
OG00412
OG00510
OG00614
OG00715
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Could not be estimated due to the low number of events
OG001NA(NA to NA)Could not be estimated due to the low number of events
OG00229(27 to NA)Could not be estimated due to the low number of events
OG003NA(29 to NA)Could not be estimated due to the low number of events
OG00430(17 to 55)
OG005114(29 to NA)Could not be estimated due to the low number of events
OG00628(25 to 36)
OG007NA(NA to NA)Could not be estimated due to the low number of events
OG002
Upadacitinib 7.5 mg / Placebo
Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
OG003
Upadacitinib 7.5 mg / Upadacitinib 7.5 mg
Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive 7.5 mg upadacitinib once a day for 72 weeks in Period 2.
OG004
Upadacitinib 15 mg / Placebo
Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
OG005
Upadacitinib 15 mg / Upadacitinib 15 mg
Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive 15 mg upadacitinib once a day for 72 weeks in Period 2.
OG006
Upadacitinib 30 mg / Placebo
Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
OG007
Upadacitinib 30 mg / Upadacitinib 30 mg
Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
Units
Counts
Participants
OG0009
OG0018
OG00210
OG00311
OG0047
OG0058
OG0065
OG0074
Title
Denominators
Categories
Week 20
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00311
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG0065
ParticipantsOG0074
Title
Measurements
OG00011.1
OG00112.5
OG0020
OG003
Week 24
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0033
Week 32
ParticipantsOG0001
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0032
Week 40
ParticipantsOG0001
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0030
Week 52
ParticipantsOG0001
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0030
Week 64
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0030
Week 76
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Week 88
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
OG003
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
OG003
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Units
Counts
Participants
OG00039
OG00142
OG00242
OG00342
Title
Denominators
Categories
Title
Measurements
OG000-4.1± 3.58
OG001-11.7± 3.48
OG002-27.1± 3.43
OG003-30.7± 3.43
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
<0.001
LS Mean Difference
-26.5
Standard Error of the Mean
4.25
2-Sided
95
-34.9
-18.1
Superiority
OG000
OG002
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
<0.001
LS Mean Difference
-23.0
Standard Error of the Mean
4.27
2-Sided
95
-31.4
-14.6
Superiority
OG000
OG001
ANCOVA
ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
0.075
LS Mean Difference
-7.6
Standard Error of the Mean
4.25
2-Sided
95
-16.0
0.8
Superiority
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Units
Counts
Participants
OG00035
OG00137
OG00232
OG00336
Title
Denominators
Categories
Title
Measurements
OG0005.7
OG00124.3
OG00259.4
OG00352.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
47.4
2-Sided
95
29.6
65.2
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
<0.001
Adjusted Difference
53.4
2-Sided
95
35.5
71.3
Superiority
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).