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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02819635




Registration number
NCT02819635
Ethics application status
Date submitted
28/06/2016
Date registered
30/06/2016
Date last updated
7/01/2021

Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
2016-000641-31
Secondary ID [2] 0 0
M14-234
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis (UC) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Updacitinib (ABT-494)

Placebo Comparator: Placebo - Administered once daily.

Experimental: Updacitinib (ABT-494) Dose A - Administered once daily.

Experimental: Updacitinib (ABT-494) Dose B - Administered once daily.

Experimental: Updacitinib (ABT-494) Dose C - Administered once daily.

Experimental: Updacitinib (ABT-494) Dose D - Administered once daily.


Treatment: Drugs: Placebo
Tablet; Oral

Treatment: Drugs: Updacitinib (ABT-494)
Tablet; Oral

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Substudy 1/Substudy 2: Percentage Of Participants Who Achieve Clinical Remission Per Adapted Mayo Score - Clinical remission per Adapted Mayo score.
Timepoint [1] 0 0
At Week 8
Primary outcome [2] 0 0
Substudy 3: Percentage Of Participants Who Achieve Clinical Remission Per Adapted Mayo Score - Clinical remission per Adapted Mayo score.
Timepoint [2] 0 0
At Week 52
Secondary outcome [1] 0 0
Substudy 1: Percentage Of Participants With Endoscopic Improvement - Endoscopic improvement defined by endoscopic subscore.
Timepoint [1] 0 0
At Week 8
Secondary outcome [2] 0 0
Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score - Clinical remission per Full Mayo score.
Timepoint [2] 0 0
At Week 8
Secondary outcome [3] 0 0
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score - Clinical response per Adapted Mayo.
Timepoint [3] 0 0
At Week 8
Secondary outcome [4] 0 0
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score - Percentage of participants achieving clinical response per Partial Mayo score.
Timepoint [4] 0 0
At Week 2
Secondary outcome [5] 0 0
Substudy 1: Change in Full Mayo Score - Change from baseline in Full Mayo score.
Timepoint [5] 0 0
Baseline (Week 0) to Week 8
Secondary outcome [6] 0 0
Substudy 1: Percentage Of Participants With Endoscopic Remission - Remission defined by endoscopic subscore.
Timepoint [6] 0 0
At Week 8
Secondary outcome [7] 0 0
Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement - Histologic improvement defined by Geboes score.
Timepoint [7] 0 0
At Week 8
Secondary outcome [8] 0 0
Substudy 2: Percentage Of Participants With Endoscopic Improvement - Endoscopic improvement defined by endoscopic subscore.
Timepoint [8] 0 0
At Week 8
Secondary outcome [9] 0 0
Substudy 2: Percentage Of Participants With Endoscopic Remission - Remission defined by endoscopic subscore.
Timepoint [9] 0 0
At Week 8
Secondary outcome [10] 0 0
Substudy 2: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score - Clinical response per Adapted Mayo.
Timepoint [10] 0 0
At Week 8
Secondary outcome [11] 0 0
Substudy 2: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score - Percentage of participants achieving clinical response per Partial Mayo score.
Timepoint [11] 0 0
At Week 2
Secondary outcome [12] 0 0
Substudy 2: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement - Histologic-endoscopic mucosal improvement defined by Endoscopic subscore and Geboes score.
Timepoint [12] 0 0
At Week 8
Secondary outcome [13] 0 0
Substudy 2: Percentage Of Participants Who Report No Bowel Urgency - Percentage of participants who report no bowel urgency.
Timepoint [13] 0 0
At Week 8
Secondary outcome [14] 0 0
Substudy 2: Percentage Of Participants Who Reported No Abdominal Pain - Percentage of participants who reported no abdominal pain.
Timepoint [14] 0 0
At Week 8
Secondary outcome [15] 0 0
Substudy 2: Percentage Of Participants Who Achieved Histologic Improvement - Histologic improvement defined by Geboes score.
Timepoint [15] 0 0
At Week 8
Secondary outcome [16] 0 0
Substudy 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score - The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Timepoint [16] 0 0
Baseline (Week 0) to Week 8
Secondary outcome [17] 0 0
Substudy 2: Percentage Of Participants With Mucosal Healing - Percentage of participants with mucosal healing.
Timepoint [17] 0 0
At Week 8
Secondary outcome [18] 0 0
Substudy 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire Score - The FACIT system is a collection of quality of life (QOL) questionnaires targeted to the management of cancer and other chronic illnesses.
Timepoint [18] 0 0
Baseline (Week 0) to Week 8
Secondary outcome [19] 0 0
Substudy 3: Percentage Of Participants With Endoscopic Improvement - Endoscopic improvement defined by endoscopic subscore.
Timepoint [19] 0 0
At Week 52
Secondary outcome [20] 0 0
Substudy 3: Percentage Of Participants Who Maintain Clinical Remission Per Adapted Mayo Score Among Participants Who Received Clinical Remission Per Adapted Mayo Score in Study M14-234 (Substudy 1 or 2) Or M14-675 - Percentage of participants who maintain clinical remission per Adapted Mayo score among participants who received clinical remission per Adapted Mayo score in Study M14-234 (Substudy 1 or 2) or M14-675.
Timepoint [20] 0 0
At Week 52
Secondary outcome [21] 0 0
Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo score And Were Corticosteroid Free = 90 days - Percentage of participants who achieved clinical remission per Adapted Mayo score and were corticosteroid free = 90 days among participants in clinical remission in the end of the induction treatment in Study M14-234 (Substudy 1 or 2) or M14-675.
Timepoint [21] 0 0
At Week 52
Secondary outcome [22] 0 0
Substudy 3: Percentage Of Participants With Endoscopic Improvement Among Participants Who Had Endoscopic Improvement In Study M14-234 (Substudy 1 or 2) Or Study M14-675 - Percentage of participants with endoscopic improvement among participants who had endoscopic improvement in Study M14-234 (Substudy 1 or 2) or Study M14-675.
Timepoint [22] 0 0
At Week 52
Secondary outcome [23] 0 0
Substudy 3: Percentage Of Participants With Endoscopic Remission - Percentage of participants with endoscopic remission.
Timepoint [23] 0 0
At Week 52
Secondary outcome [24] 0 0
Substudy 3: Percentage Of Participants Who Maintain Clinical Response Per Adapted Mayo Score - Percentage of participants who maintain clinical response per Adapted Mayo score.
Timepoint [24] 0 0
At Week 52
Secondary outcome [25] 0 0
Substudy 3: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement - Histologic-endoscopic mucosal improvement defined by Endoscopic subscore and Geboes score.
Timepoint [25] 0 0
At Week 52
Secondary outcome [26] 0 0
Substudy 3: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score - The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Timepoint [26] 0 0
Baseline (Week 0) to Week 52
Secondary outcome [27] 0 0
Substudy 3: Percentage Of Participants With Mucosal Healing - Percentage of participants with mucosal healing.
Timepoint [27] 0 0
At Week 52
Secondary outcome [28] 0 0
Substudy 3: Percentage Of Participants Who Reported No Bowel Urgency - Percentage of participants who reported no bowel urgency.
Timepoint [28] 0 0
At Week 52
Secondary outcome [29] 0 0
Substudy 3: Percentage Of Participants Who Reported No Abdominal Pain - Percentage of participants who reported no abdominal pain.
Timepoint [29] 0 0
At Week 52
Secondary outcome [30] 0 0
Substudy 3: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score - The FACIT-F is a validated tool that measures an individual's level of fatigue during their usual daily activities.
Timepoint [30] 0 0
Baseline (Week 0) to Week 52
Secondary outcome [31] 0 0
Substudy 3: Incidence Rate Of Ulcerative Colitis (UC)-Related Hospitalization - Incidence of UC-related hospitalization.
Timepoint [31] 0 0
At Week 52
Secondary outcome [32] 0 0
Substudy 3: Incidence Rate of Ulcerative Colitis (UC)-Related Surgeries - Incidence rate of UC-related surgeries.
Timepoint [32] 0 0
At Week 52

Eligibility
Key inclusion criteria
Note: Adolescent participants at the age of 16 or 17 years old will be eligible to
participate if approved by the country or regulatory/health authority. If approval has not
been granted, only participants >= 18 years old will be enrolled.

Adolescents must weigh >= 40 kilograms and meet the definition of Tanner Stage 5 at
Screening Visit.

- Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by
colonoscopy during the Screening Period, with exclusion of current infection, colonic
dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent
with the diagnosis of UC, in the assessment of the Investigator, must be available.

- Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic
sub score of 2 to 3 (confirmed by central reader).

- Demonstrated an inadequate response to, loss of response to, or intolerance to at
least one of the following treatments including: oral aminosalicylates,
corticosteroids, immunosuppressants, and/or biologic therapies in the opinion of the
investigator.

Note: Participants who have had inadequate response, loss of response to conventional
therapy, but have not failed biologic therapy (Non-bio-IR) and have received a prior
biologic for up to 1 year may be enrolled, however they must have discontinued the biologic
for reasons other than inadequate response or intolerance (e.g., change of insurance, well
controlled disease) and must meet criteria for inadequate response, loss of response or
intolerance to aminosalicylates, corticosteroids, and/or immunosuppressants as defined
above.

- If female, participant must meet the criteria for Contraception Recommendations.

- Female participants of childbearing potential must have a negative serum pregnancy
test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit
prior to study drug dosing.
Minimum age
16 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant with current diagnosis of Crohn's disease (CD) or diagnosis of
indeterminate colitis (IC).

- Current diagnosis of fulminant colitis and/or toxic megacolon.

- Participant with disease limited to the rectum (ulcerative proctitis) during the
Screening endoscopy.

- Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30
days prior to Baseline.

- Participant on azathioprine or 6-mercaptopurine within 10 days of baseline.

- Received intravenous corticosteroids within 14 days prior to Screening or during the
Screening Period.

- Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g.,
tofacitinib, baricitinib, filgotinib, upadacitinib).

- Screening laboratory and other analyses show any abnormal results.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Macquarie University /ID# 211951 - Macquarie Park
Recruitment hospital [2] 0 0
Mater Misericordiae /ID# 212685 - South Brisbane
Recruitment hospital [3] 0 0
Griffith University /ID# 211952 - Southport
Recruitment hospital [4] 0 0
Monash Health /ID# 150206 - Clayton
Recruitment hospital [5] 0 0
St. Vincents Hosp Melbourne /ID# 152472 - Fitzroy
Recruitment hospital [6] 0 0
Fiona Stanley Hospital /ID# 211640 - Murdoch
Recruitment postcode(s) [1] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
4222 - Southport
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
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Florida
Country [7] 0 0
United States of America
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Georgia
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Mississippi
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Missouri
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Nevada
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Ciudad Autonoma Buenos Aires
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Cordoba
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Wien
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Salzburg
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Vitebsk
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Ghent
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Leuven
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Roeselare
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Republika Srpska
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Tuzlanski
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Mostar
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Bosnia and Herzegovina
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Sarajevo
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Concepción
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Chile
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China
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Wuhan
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Colombia
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Medellin
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Croatia
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Osjecko-baranjska Zupanija
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Croatia
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Primorsko-goranska Zupanija
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Croatia
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Split
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Zadar
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Zagreb
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Czechia
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Helsinki
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Mikkeli
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Somme
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SAINT-ETIENNE Cedex 1
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Germany
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Baden-Wuerttemberg
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Germany
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Niedersachsen
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Germany
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Schleswig-Holstein
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Berlin
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Frankfurt
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Munster
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Germany
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Wiesbaden
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Greece
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Attiki
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Greece
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Athens
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Greece
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Heraklion
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Ioannina
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Vas
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Israel
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HaDarom
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Israel
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Israel
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Haifa
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Israel
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Jerusalem
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Emilia-Romagna
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Lazio
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Milano
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Sicilia
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Rome
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State/province [145] 0 0
Aichi
Country [146] 0 0
Japan
State/province [146] 0 0
Aomori
Country [147] 0 0
Japan
State/province [147] 0 0
Chiba
Country [148] 0 0
Japan
State/province [148] 0 0
Fukui
Country [149] 0 0
Japan
State/province [149] 0 0
Fukuoka
Country [150] 0 0
Japan
State/province [150] 0 0
Gifu
Country [151] 0 0
Japan
State/province [151] 0 0
Hiroshima
Country [152] 0 0
Japan
State/province [152] 0 0
Hokkaido
Country [153] 0 0
Japan
State/province [153] 0 0
Hyogo
Country [154] 0 0
Japan
State/province [154] 0 0
Ibaraki
Country [155] 0 0
Japan
State/province [155] 0 0
Ishikawa
Country [156] 0 0
Japan
State/province [156] 0 0
Iwate
Country [157] 0 0
Japan
State/province [157] 0 0
Kagoshima
Country [158] 0 0
Japan
State/province [158] 0 0
Kanagawa
Country [159] 0 0
Japan
State/province [159] 0 0
Kyoto
Country [160] 0 0
Japan
State/province [160] 0 0
Mie
Country [161] 0 0
Japan
State/province [161] 0 0
Miyagi
Country [162] 0 0
Japan
State/province [162] 0 0
Nagasaki
Country [163] 0 0
Japan
State/province [163] 0 0
Nara
Country [164] 0 0
Japan
State/province [164] 0 0
Niigata
Country [165] 0 0
Japan
State/province [165] 0 0
Oita
Country [166] 0 0
Japan
State/province [166] 0 0
Okayama
Country [167] 0 0
Japan
State/province [167] 0 0
Osaka
Country [168] 0 0
Japan
State/province [168] 0 0
Saga
Country [169] 0 0
Japan
State/province [169] 0 0
Saitama
Country [170] 0 0
Japan
State/province [170] 0 0
Shiga
Country [171] 0 0
Japan
State/province [171] 0 0
Shizuoka
Country [172] 0 0
Japan
State/province [172] 0 0
Tokyo
Country [173] 0 0
Japan
State/province [173] 0 0
Yamagata
Country [174] 0 0
Japan
State/province [174] 0 0
Yamaguchi
Country [175] 0 0
Japan
State/province [175] 0 0
Yamanashi
Country [176] 0 0
Japan
State/province [176] 0 0
Izumo
Country [177] 0 0
Japan
State/province [177] 0 0
Kashiwa
Country [178] 0 0
Japan
State/province [178] 0 0
Kitakyushu
Country [179] 0 0
Japan
State/province [179] 0 0
Takatsuki-shi
Country [180] 0 0
Korea, Republic of
State/province [180] 0 0
Busan Gwang Yeogsi
Country [181] 0 0
Korea, Republic of
State/province [181] 0 0
Daegu Gwang Yeogsi
Country [182] 0 0
Korea, Republic of
State/province [182] 0 0
Gyeonggido
Country [183] 0 0
Korea, Republic of
State/province [183] 0 0
Seoul Teugbyeolsi
Country [184] 0 0
Korea, Republic of
State/province [184] 0 0
Guri-si
Country [185] 0 0
Korea, Republic of
State/province [185] 0 0
Seoul
Country [186] 0 0
Latvia
State/province [186] 0 0
Riga
Country [187] 0 0
Lithuania
State/province [187] 0 0
Kaunas
Country [188] 0 0
Lithuania
State/province [188] 0 0
Klaipeda
Country [189] 0 0
Lithuania
State/province [189] 0 0
Vilnius
Country [190] 0 0
Malaysia
State/province [190] 0 0
Kedah
Country [191] 0 0
Malaysia
State/province [191] 0 0
Selangor
Country [192] 0 0
Malaysia
State/province [192] 0 0
Ampang, Selangor
Country [193] 0 0
Malaysia
State/province [193] 0 0
Kuala Lumpur
Country [194] 0 0
Mexico
State/province [194] 0 0
Guanajuato
Country [195] 0 0
Mexico
State/province [195] 0 0
Jalisco
Country [196] 0 0
Mexico
State/province [196] 0 0
Nuevo Leon
Country [197] 0 0
Netherlands
State/province [197] 0 0
Gelderland
Country [198] 0 0
Netherlands
State/province [198] 0 0
Noord-Holland
Country [199] 0 0
Netherlands
State/province [199] 0 0
Leiden
Country [200] 0 0
Netherlands
State/province [200] 0 0
Rotterdam
Country [201] 0 0
Netherlands
State/province [201] 0 0
Utrecht
Country [202] 0 0
Norway
State/province [202] 0 0
Akershus
Country [203] 0 0
Norway
State/province [203] 0 0
Troms
Country [204] 0 0
Poland
State/province [204] 0 0
Mazowieckie
Country [205] 0 0
Poland
State/province [205] 0 0
Pomorskie
Country [206] 0 0
Poland
State/province [206] 0 0
Torun
Country [207] 0 0
Poland
State/province [207] 0 0
Warsaw
Country [208] 0 0
Portugal
State/province [208] 0 0
Braga
Country [209] 0 0
Portugal
State/province [209] 0 0
Lisboa
Country [210] 0 0
Portugal
State/province [210] 0 0
Setubal
Country [211] 0 0
Portugal
State/province [211] 0 0
Porto
Country [212] 0 0
Portugal
State/province [212] 0 0
Santa Maria Da Feira
Country [213] 0 0
Portugal
State/province [213] 0 0
Viana Do Castelo
Country [214] 0 0
Puerto Rico
State/province [214] 0 0
San Juan
Country [215] 0 0
Russian Federation
State/province [215] 0 0
Kaliningradskaya Oblast
Country [216] 0 0
Russian Federation
State/province [216] 0 0
Leningradskaya Oblast
Country [217] 0 0
Russian Federation
State/province [217] 0 0
Permskiy Kray
Country [218] 0 0
Russian Federation
State/province [218] 0 0
Samarskaya Oblast
Country [219] 0 0
Russian Federation
State/province [219] 0 0
Stavropol Skiy Kray
Country [220] 0 0
Russian Federation
State/province [220] 0 0
Tatarstan, Respublika
Country [221] 0 0
Russian Federation
State/province [221] 0 0
Moscow
Country [222] 0 0
Russian Federation
State/province [222] 0 0
Petrozavodsk
Country [223] 0 0
Russian Federation
State/province [223] 0 0
Pushkin
Country [224] 0 0
Russian Federation
State/province [224] 0 0
Stavropol
Country [225] 0 0
Serbia
State/province [225] 0 0
Beograd
Country [226] 0 0
Serbia
State/province [226] 0 0
Nisavski Okrug
Country [227] 0 0
Serbia
State/province [227] 0 0
Sumadijski Okrug
Country [228] 0 0
Serbia
State/province [228] 0 0
Vojvodina
Country [229] 0 0
Serbia
State/province [229] 0 0
Leskovac
Country [230] 0 0
Singapore
State/province [230] 0 0
Singapore
Country [231] 0 0
Slovakia
State/province [231] 0 0
Bratislavsky Kraj
Country [232] 0 0
Slovakia
State/province [232] 0 0
Banska Bystrica
Country [233] 0 0
Slovakia
State/province [233] 0 0
Ilava
Country [234] 0 0
Slovakia
State/province [234] 0 0
Kosice
Country [235] 0 0
Slovakia
State/province [235] 0 0
Nove Zamky
Country [236] 0 0
Slovakia
State/province [236] 0 0
Presov
Country [237] 0 0
South Africa
State/province [237] 0 0
Gauteng
Country [238] 0 0
South Africa
State/province [238] 0 0
Western Cape
Country [239] 0 0
South Africa
State/province [239] 0 0
Boksburg North
Country [240] 0 0
Spain
State/province [240] 0 0
A Coruna
Country [241] 0 0
Spain
State/province [241] 0 0
Cantabria
Country [242] 0 0
Spain
State/province [242] 0 0
Barcelona
Country [243] 0 0
Spain
State/province [243] 0 0
Cordoba
Country [244] 0 0
Spain
State/province [244] 0 0
Las Palmas de Gran Canaria
Country [245] 0 0
Spain
State/province [245] 0 0
Madrid
Country [246] 0 0
Spain
State/province [246] 0 0
Salamanca
Country [247] 0 0
Spain
State/province [247] 0 0
Valencia
Country [248] 0 0
Sweden
State/province [248] 0 0
Goteborg
Country [249] 0 0
Switzerland
State/province [249] 0 0
Sankt Gallen
Country [250] 0 0
Switzerland
State/province [250] 0 0
Zuerich
Country [251] 0 0
Switzerland
State/province [251] 0 0
Basel
Country [252] 0 0
Switzerland
State/province [252] 0 0
Bern
Country [253] 0 0
Taiwan
State/province [253] 0 0
Taichung
Country [254] 0 0
Taiwan
State/province [254] 0 0
Tainan
Country [255] 0 0
Taiwan
State/province [255] 0 0
Taipei
Country [256] 0 0
Taiwan
State/province [256] 0 0
Kaohsiung
Country [257] 0 0
Taiwan
State/province [257] 0 0
Taichung City
Country [258] 0 0
Taiwan
State/province [258] 0 0
Taipei City
Country [259] 0 0
Turkey
State/province [259] 0 0
Kayseri
Country [260] 0 0
Turkey
State/province [260] 0 0
Ankara
Country [261] 0 0
Turkey
State/province [261] 0 0
Istanbul
Country [262] 0 0
Turkey
State/province [262] 0 0
Mersin
Country [263] 0 0
Ukraine
State/province [263] 0 0
Kharkivska Oblast
Country [264] 0 0
Ukraine
State/province [264] 0 0
Kyivska Oblast
Country [265] 0 0
Ukraine
State/province [265] 0 0
Kyiv
Country [266] 0 0
Ukraine
State/province [266] 0 0
Vinnytska Oblast
Country [267] 0 0
Ukraine
State/province [267] 0 0
Dnipro
Country [268] 0 0
Ukraine
State/province [268] 0 0
Kropyvnytskyi
Country [269] 0 0
Ukraine
State/province [269] 0 0
Lviv
Country [270] 0 0
Ukraine
State/province [270] 0 0
Odesa
Country [271] 0 0
Ukraine
State/province [271] 0 0
Vinnytsia
Country [272] 0 0
United Kingdom
State/province [272] 0 0
Devon
Country [273] 0 0
United Kingdom
State/province [273] 0 0
Glasgow City
Country [274] 0 0
United Kingdom
State/province [274] 0 0
London, City Of
Country [275] 0 0
United Kingdom
State/province [275] 0 0
Basingstoke
Country [276] 0 0
United Kingdom
State/province [276] 0 0
Bath
Country [277] 0 0
United Kingdom
State/province [277] 0 0
Birmingham
Country [278] 0 0
United Kingdom
State/province [278] 0 0
Huddersfield
Country [279] 0 0
United Kingdom
State/province [279] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study comprises three sub-studies. The objective of sub-study 1 is to characterize the
dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical
remission in order to identify the induction dose of upadacitinib for further evaluation in
sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of
upadacitinib compared to placebo in inducing clinical remission in participants. The
objective of sub-study 3 is to evaluate the efficacy and safety of upadacitinib compared to
placebo in achieving clinical remission in participants who had a response following
induction with upadacitinib.
Trial website
https://clinicaltrials.gov/show/NCT02819635
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications