Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02925117
Registration number
NCT02925117
Ethics application status
Date submitted
4/10/2016
Date registered
5/10/2016
Date last updated
16/07/2020
Titles & IDs
Public title
A Study to Evaluate ABT-494 (Upadacitinib) in Adults With Moderate to Severe Atopic Dermatitis
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2016-002451-21
Query!
Secondary ID [2]
0
0
M16-048
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
0
0
Query!
Condition category
Condition code
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Placebo
Placebo Comparator: 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.
Experimental: Upadacitinib 7.5 mg - 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.
Experimental: 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.
Experimental: 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.
Treatment: Drugs: Upadacitinib
Tablet for oral use
Treatment: Drugs: Placebo
Tablet
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline and Week 16
Query!
Secondary outcome [1]
0
0
Percentage of Participants Who Achieved a 75% Reduction in EASI Score (EASI 75) at Week 16
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
Baseline and Week 16
Query!
Secondary outcome [2]
0
0
Percentage of Participants Achieving an Investigator Global Assessment (IGA) of "0" or "1" at Week 16
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Week 16
Query!
Secondary outcome [3]
0
0
Percent Change From Baseline to Weeks 2, 8, and 16 in Pruritus Numerical Rating Scale (NRS)
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline and Weeks 2, 8, and 16
Query!
Secondary outcome [4]
0
0
Percent Change From Baseline in EASI Score at Week 8
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline and Week 8
Query!
Secondary outcome [5]
0
0
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Weeks 8 and 16
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline and Weeks 8 and 16
Query!
Secondary outcome [6]
0
0
Percentage of Participants Who Achieved an EASI 75 Response at Week 8
Query!
Assessment method [6]
0
0
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).
Query!
Timepoint [6]
0
0
Baseline and Week 8
Query!
Secondary outcome [7]
0
0
Percentage of Participants Who Achieved an EASI 50 Response at Weeks 8 and 16
Query!
Assessment method [7]
0
0
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).
Query!
Timepoint [7]
0
0
Baseline and Weeks 8 and 16
Query!
Secondary outcome [8]
0
0
Percentage of Participants Who Achieved an EASI 90 Response at Weeks 8 and 16
Query!
Assessment method [8]
0
0
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).
Query!
Timepoint [8]
0
0
Baseline and Weeks 8 and 16
Query!
Secondary outcome [9]
0
0
Percentage of Participants Who Achieved a SCORAD 50 Response at Weeks 8 and 16
Query!
Assessment method [9]
0
0
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).
Query!
Timepoint [9]
0
0
Baseline and Weeks 8 and 16
Query!
Secondary outcome [10]
0
0
Percentage of Participants Who Achieved a SCORAD 75 Response at Weeks 8 and 16
Query!
Assessment method [10]
0
0
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).
Query!
Timepoint [10]
0
0
Baseline and Weeks 8 and 16
Query!
Secondary outcome [11]
0
0
Percentage of Participants Who Achieved a SCORAD 90 Response at Weeks 8 and 16
Query!
Assessment method [11]
0
0
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).
Query!
Timepoint [11]
0
0
Baseline and Weeks 8 and 16
Query!
Secondary outcome [12]
0
0
Percent Change From Re-randomization (Week 16) in EASI Score in Period 2
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
Re-randomization (Week 16) and Weeks 20, 24, 32, 40, 52, 64, 76, and 88
Query!
Secondary outcome [13]
0
0
Time to Loss of EASI 50 Response Relative to Baseline Among Participants Re-randomized as EASI 75 Responders at Week 16
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
From re-randomization at Week 16 until Week 88
Query!
Secondary outcome [14]
0
0
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
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
Weeks 20, 24, 32, 40, 52, 64, 76, and 88
Query!
Secondary outcome [15]
0
0
Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) of "0" or "1" at Weeks 8 and 16
Query!
Assessment method [15]
0
0
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.
Query!
Timepoint [15]
0
0
Weeks 8 and 16
Query!
Secondary outcome [16]
0
0
Change From Baseline in DLQI at Weeks 8 and 16
Query!
Assessment method [16]
0
0
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.
Query!
Timepoint [16]
0
0
Baseline and Weeks 8 and 16
Query!
Secondary outcome [17]
0
0
Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16
Query!
Assessment method [17]
0
0
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.
Query!
Timepoint [17]
0
0
Baseline and Week 16
Query!
Secondary outcome [18]
0
0
Percentage of Participants With Reduction of = 4 Points From Baseline in Pruritus NRS at Week 16
Query!
Assessment method [18]
0
0
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).
Query!
Timepoint [18]
0
0
Baseline and Week 16
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
25/10/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
31/01/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
167
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Woden Dermatology /ID# 157907 - Phillip
Query!
Recruitment hospital [2]
0
0
St George Hospital /ID# 157908 - Kogarah
Query!
Recruitment hospital [3]
0
0
Specialist Connect Pty Ltd /ID# 157909 - Woolloongabba
Query!
Recruitment hospital [4]
0
0
Skin Health Institute Inc /ID# 157906 - Carlton
Query!
Recruitment postcode(s) [1]
0
0
2606 - Phillip
Query!
Recruitment postcode(s) [2]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [3]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [4]
0
0
3053 - Carlton
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Florida
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Georgia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Maryland
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Massachusetts
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
New Jersey
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
New York
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Texas
Query!
Country [8]
0
0
Canada
Query!
State/province [8]
0
0
Alberta
Query!
Country [9]
0
0
Canada
Query!
State/province [9]
0
0
British Columbia
Query!
Country [10]
0
0
Canada
Query!
State/province [10]
0
0
Ontario
Query!
Country [11]
0
0
Finland
Query!
State/province [11]
0
0
Varsinais-Suomi
Query!
Country [12]
0
0
Finland
Query!
State/province [12]
0
0
Mikkeli
Query!
Country [13]
0
0
Germany
Query!
State/province [13]
0
0
Hamburg
Query!
Country [14]
0
0
Japan
Query!
State/province [14]
0
0
Fukuoka
Query!
Country [15]
0
0
Japan
Query!
State/province [15]
0
0
Hokkaido
Query!
Country [16]
0
0
Japan
Query!
State/province [16]
0
0
Tokyo
Query!
Country [17]
0
0
Netherlands
Query!
State/province [17]
0
0
Gelderland
Query!
Country [18]
0
0
Netherlands
Query!
State/province [18]
0
0
Noord-Holland
Query!
Country [19]
0
0
Netherlands
Query!
State/province [19]
0
0
Groningen
Query!
Country [20]
0
0
Netherlands
Query!
State/province [20]
0
0
Utrecht
Query!
Country [21]
0
0
Spain
Query!
State/province [21]
0
0
Barcelona
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
AbbVie
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02925117
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
AbbVie Inc.
Query!
Address
0
0
AbbVie
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02925117
Download to PDF