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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02819635
Ethics application status
Date submitted
28/06/2016
Date registered
30/06/2016
Date last updated
30/06/2022

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 - Upadacitinib

Placebo comparator: SS1: Placebo - During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.

Experimental: SS1: Upadacitinib 7.5 mg - During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.

Experimental: SS1: Upadacitinib 15 mg - During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.

Experimental: SS1: Upadacitinib 30 mg - During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.

Experimental: SS1: Upadacitinib 45 mg - During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.

Experimental: SS2: Placebo/Upadacitinib 45 mg - During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.

Experimental: SS2: Upadacitinib 45 mg/Upadacitinib 45 mg - During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.

Experimental: SS3: M14-675 clinical responders - Participants in Study M14-675 (NCT03653026) who achieved clinical response defined by Adapted Mayo Score at Week 8 or Week 16 in that study and did not meet any study discontinuation criteria were eligible to enroll into Substudy 3. Participants were re-randomized and treated with a blinded treatment assignment (15 mg upadacitinib film-coated tablets once daily by mouth \[QD\], or 30 mg upadacitinib film-coated tablets QD, or placebo for upadacitinib film-coated tablets QD) for up to 52 weeks.


Treatment: Drugs: Placebo
Film-coated tablet for oral administration

Treatment: Drugs: Upadacitinib
Film-coated tablet for oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
Timepoint [1] 0 0
At Week 8
Primary outcome [2] 0 0
Substudy 2: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
Timepoint [2] 0 0
At Week 8
Primary outcome [3] 0 0
Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52
Timepoint [3] 0 0
At Week 52
Secondary outcome [1] 0 0
Substudy 1: Percentage Of Participants With Endoscopic Improvement at Week 8
Timepoint [1] 0 0
At Week 8
Secondary outcome [2] 0 0
Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score at Week 8
Timepoint [2] 0 0
At Week 8
Secondary outcome [3] 0 0
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8
Timepoint [3] 0 0
At Week 8
Secondary outcome [4] 0 0
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2
Timepoint [4] 0 0
At Week 2
Secondary outcome [5] 0 0
Substudy 1: Change in Full Mayo Score From Baseline to Week 8
Timepoint [5] 0 0
Baseline (Week 0), Week 8
Secondary outcome [6] 0 0
Substudy 1: Percentage Of Participants With Endoscopic Remission at Week 8
Timepoint [6] 0 0
At Week 8
Secondary outcome [7] 0 0
Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement at Week 8
Timepoint [7] 0 0
At Week 8
Secondary outcome [8] 0 0
Substudy 2: Percentage Of Participants With Endoscopic Improvement at Week 8
Timepoint [8] 0 0
At Week 8
Secondary outcome [9] 0 0
Substudy 2: Percentage Of Participants With Endoscopic Remission at Week 8
Timepoint [9] 0 0
At Week 8
Secondary outcome [10] 0 0
Substudy 2: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8
Timepoint [10] 0 0
At Week 8
Secondary outcome [11] 0 0
Substudy 2: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2
Timepoint [11] 0 0
At Week 2
Secondary outcome [12] 0 0
Substudy 2: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8
Timepoint [12] 0 0
At Week 8
Secondary outcome [13] 0 0
Substudy 2: Percentage Of Participants Who Report No Bowel Urgency at Week 8
Timepoint [13] 0 0
At Week 8
Secondary outcome [14] 0 0
Substudy 2: Percentage Of Participants Who Reported No Abdominal Pain at Week 8
Timepoint [14] 0 0
At Week 8
Secondary outcome [15] 0 0
Substudy 2: Percentage Of Participants Who Achieved Histologic Improvement at Week 8
Timepoint [15] 0 0
At Week 8
Secondary outcome [16] 0 0
Substudy 2: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 8
Timepoint [16] 0 0
Baseline (Week 0), Week 8
Secondary outcome [17] 0 0
Substudy 2: Percentage Of Participants With Mucosal Healing at Week 8
Timepoint [17] 0 0
At Week 8
Secondary outcome [18] 0 0
Substudy 2: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 8
Timepoint [18] 0 0
Baseline (Week 0), Week 8
Secondary outcome [19] 0 0
Substudy 3: Percentage Of Participants With Endoscopic Improvement at Week 52
Timepoint [19] 0 0
At Week 52
Secondary outcome [20] 0 0
Substudy 3: Percentage of Participants With Clinical Remission Per Adapted Mayo Score at Week 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment
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 at Wk 52 and Were Corticosteroid Free for = 90 Days Immediately Preceding Wk 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment
Timepoint [21] 0 0
At Week 52
Secondary outcome [22] 0 0
Substudy 3: Percentage of Participants With Endoscopic Improvement at Wk 52 Among Those Who Achieved Endoscopic Improvement at the End of the Induction Treatment
Timepoint [22] 0 0
At Week 52
Secondary outcome [23] 0 0
Substudy 3: Percentage Of Participants With Endoscopic Remission At Week 52
Timepoint [23] 0 0
At Week 52
Secondary outcome [24] 0 0
Substudy 3: Percentage Of Participants Who Maintained Clinical Response Per Adapted Mayo Score at Wk 52 Among Those Who Achieved Clinical Response at the End of the Induction Treatment
Timepoint [24] 0 0
At Week 52
Secondary outcome [25] 0 0
Substudy 3: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 52
Timepoint [25] 0 0
At Week 52
Secondary outcome [26] 0 0
Substudy 3: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52
Timepoint [26] 0 0
Baseline (Week 0), Week 52
Secondary outcome [27] 0 0
Substudy 3: Percentage Of Participants With Mucosal Healing at Week 52
Timepoint [27] 0 0
At Week 52
Secondary outcome [28] 0 0
Substudy 3: Percentage Of Participants Who Reported No Bowel Urgency at Week 52
Timepoint [28] 0 0
At Week 52
Secondary outcome [29] 0 0
Substudy 3: Percentage Of Participants Who Reported No Abdominal Pain at Week 52
Timepoint [29] 0 0
At Week 52
Secondary outcome [30] 0 0
Substudy 3: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 52
Timepoint [30] 0 0
Baseline (Week 0), Week 52

Eligibility
Key inclusion criteria
Note: Adolescent participants who are 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
Sex
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 meeting the exclusion criteria

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/12/2021
Sample size
Target
Accrual to date
Final
1302
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Macquarie University Hospital /ID# 211951 - Macquarie University
Recruitment hospital [2] 0 0
Mater Misericordiae Limited /ID# 212685 - South Brisbane
Recruitment hospital [3] 0 0
Griffith University /ID# 211952 - Southport
Recruitment hospital [4] 0 0
Monash Medical Centre /ID# 150206 - Clayton
Recruitment hospital [5] 0 0
St Vincent's Hospital Melbourne /ID# 152472 - Fitzroy Melbourne
Recruitment hospital [6] 0 0
Fiona Stanley Hospital /ID# 211640 - Murdoch
Recruitment postcode(s) [1] 0 0
2109 - Macquarie University
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 Melbourne
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
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???????
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Fukui
Country [143] 0 0
Japan
State/province [143] 0 0
Fukuoka
Country [144] 0 0
Japan
State/province [144] 0 0
Gifu
Country [145] 0 0
Japan
State/province [145] 0 0
Hiroshima
Country [146] 0 0
Japan
State/province [146] 0 0
Hokkaido
Country [147] 0 0
Japan
State/province [147] 0 0
Hyogo
Country [148] 0 0
Japan
State/province [148] 0 0
Ibaraki
Country [149] 0 0
Japan
State/province [149] 0 0
Ishikawa
Country [150] 0 0
Japan
State/province [150] 0 0
Iwate
Country [151] 0 0
Japan
State/province [151] 0 0
Kagoshima
Country [152] 0 0
Japan
State/province [152] 0 0
Kanagawa
Country [153] 0 0
Japan
State/province [153] 0 0
Kyoto
Country [154] 0 0
Japan
State/province [154] 0 0
Mie
Country [155] 0 0
Japan
State/province [155] 0 0
Miyagi
Country [156] 0 0
Japan
State/province [156] 0 0
Nagasaki
Country [157] 0 0
Japan
State/province [157] 0 0
Nara
Country [158] 0 0
Japan
State/province [158] 0 0
Niigata
Country [159] 0 0
Japan
State/province [159] 0 0
Oita
Country [160] 0 0
Japan
State/province [160] 0 0
Okayama
Country [161] 0 0
Japan
State/province [161] 0 0
Osaka
Country [162] 0 0
Japan
State/province [162] 0 0
Saga
Country [163] 0 0
Japan
State/province [163] 0 0
Saitama
Country [164] 0 0
Japan
State/province [164] 0 0
Shiga
Country [165] 0 0
Japan
State/province [165] 0 0
Shimane
Country [166] 0 0
Japan
State/province [166] 0 0
Shizuoka
Country [167] 0 0
Japan
State/province [167] 0 0
Tokyo
Country [168] 0 0
Japan
State/province [168] 0 0
Yamagata
Country [169] 0 0
Japan
State/province [169] 0 0
Yamaguchi
Country [170] 0 0
Japan
State/province [170] 0 0
Yamanashi
Country [171] 0 0
Japan
State/province [171] 0 0
Takatsuki-shi
Country [172] 0 0
Korea, Republic of
State/province [172] 0 0
Gyeonggido
Country [173] 0 0
Korea, Republic of
State/province [173] 0 0
Seoul Teugbyeolsi
Country [174] 0 0
Korea, Republic of
State/province [174] 0 0
Busan
Country [175] 0 0
Korea, Republic of
State/province [175] 0 0
Daegu
Country [176] 0 0
Korea, Republic of
State/province [176] 0 0
Seoul
Country [177] 0 0
Latvia
State/province [177] 0 0
Riga
Country [178] 0 0
Lithuania
State/province [178] 0 0
Kaunas
Country [179] 0 0
Lithuania
State/province [179] 0 0
Klaipeda
Country [180] 0 0
Lithuania
State/province [180] 0 0
Vilnius
Country [181] 0 0
Malaysia
State/province [181] 0 0
Kedah
Country [182] 0 0
Malaysia
State/province [182] 0 0
Selangor
Country [183] 0 0
Malaysia
State/province [183] 0 0
Ampang
Country [184] 0 0
Malaysia
State/province [184] 0 0
Kuala Lumpur
Country [185] 0 0
Mexico
State/province [185] 0 0
Guanajuato
Country [186] 0 0
Mexico
State/province [186] 0 0
Jalisco
Country [187] 0 0
Mexico
State/province [187] 0 0
Nuevo Leon
Country [188] 0 0
Netherlands
State/province [188] 0 0
Gelderland
Country [189] 0 0
Netherlands
State/province [189] 0 0
Zuid-Holland
Country [190] 0 0
Netherlands
State/province [190] 0 0
Amsterdam
Country [191] 0 0
Netherlands
State/province [191] 0 0
Leiden
Country [192] 0 0
Netherlands
State/province [192] 0 0
Utrecht
Country [193] 0 0
Norway
State/province [193] 0 0
Akershus
Country [194] 0 0
Norway
State/province [194] 0 0
Troms
Country [195] 0 0
Poland
State/province [195] 0 0
Kujawsko-pomorskie
Country [196] 0 0
Poland
State/province [196] 0 0
Mazowieckie
Country [197] 0 0
Poland
State/province [197] 0 0
Pomorskie
Country [198] 0 0
Portugal
State/province [198] 0 0
Braga
Country [199] 0 0
Portugal
State/province [199] 0 0
Porto
Country [200] 0 0
Portugal
State/province [200] 0 0
Viana Do Castelo
Country [201] 0 0
Portugal
State/province [201] 0 0
Almada
Country [202] 0 0
Portugal
State/province [202] 0 0
Lisboa
Country [203] 0 0
Puerto Rico
State/province [203] 0 0
San Juan
Country [204] 0 0
Russian Federation
State/province [204] 0 0
Kaliningradskaya Oblast
Country [205] 0 0
Russian Federation
State/province [205] 0 0
Leningradskaya Oblast
Country [206] 0 0
Russian Federation
State/province [206] 0 0
Permskiy Kray
Country [207] 0 0
Russian Federation
State/province [207] 0 0
Samarskaya Oblast
Country [208] 0 0
Russian Federation
State/province [208] 0 0
Stavropol Skiy Kray
Country [209] 0 0
Russian Federation
State/province [209] 0 0
Tatarstan, Respublika
Country [210] 0 0
Russian Federation
State/province [210] 0 0
Moscow
Country [211] 0 0
Russian Federation
State/province [211] 0 0
Petrozavodsk
Country [212] 0 0
Russian Federation
State/province [212] 0 0
Pushkin
Country [213] 0 0
Russian Federation
State/province [213] 0 0
Stavropol
Country [214] 0 0
Serbia
State/province [214] 0 0
Beograd
Country [215] 0 0
Serbia
State/province [215] 0 0
Nisavski Okrug
Country [216] 0 0
Serbia
State/province [216] 0 0
Sumadijski Okrug
Country [217] 0 0
Serbia
State/province [217] 0 0
Vojvodina
Country [218] 0 0
Serbia
State/province [218] 0 0
Leskovac
Country [219] 0 0
Singapore
State/province [219] 0 0
Singapore
Country [220] 0 0
Slovakia
State/province [220] 0 0
Banska Bystrica
Country [221] 0 0
Slovakia
State/province [221] 0 0
Bratislava
Country [222] 0 0
Slovakia
State/province [222] 0 0
Ilava
Country [223] 0 0
Slovakia
State/province [223] 0 0
Kosice
Country [224] 0 0
Slovakia
State/province [224] 0 0
Nove Zamky
Country [225] 0 0
Slovakia
State/province [225] 0 0
Presov
Country [226] 0 0
South Africa
State/province [226] 0 0
Gauteng
Country [227] 0 0
South Africa
State/province [227] 0 0
Western Cape
Country [228] 0 0
Spain
State/province [228] 0 0
A Coruna
Country [229] 0 0
Spain
State/province [229] 0 0
Cantabria
Country [230] 0 0
Spain
State/province [230] 0 0
Las Palmas
Country [231] 0 0
Spain
State/province [231] 0 0
Barcelona
Country [232] 0 0
Spain
State/province [232] 0 0
Cordoba
Country [233] 0 0
Spain
State/province [233] 0 0
Madrid
Country [234] 0 0
Spain
State/province [234] 0 0
Salamanca
Country [235] 0 0
Spain
State/province [235] 0 0
Valencia
Country [236] 0 0
Sweden
State/province [236] 0 0
Vastra Gotalands Lan
Country [237] 0 0
Switzerland
State/province [237] 0 0
Basel-Stadt
Country [238] 0 0
Switzerland
State/province [238] 0 0
Sankt Gallen
Country [239] 0 0
Switzerland
State/province [239] 0 0
Zuerich
Country [240] 0 0
Switzerland
State/province [240] 0 0
Bern
Country [241] 0 0
Taiwan
State/province [241] 0 0
Kaohsiung
Country [242] 0 0
Taiwan
State/province [242] 0 0
Taichung City
Country [243] 0 0
Taiwan
State/province [243] 0 0
Taichung
Country [244] 0 0
Taiwan
State/province [244] 0 0
Tainan
Country [245] 0 0
Taiwan
State/province [245] 0 0
Taipei City
Country [246] 0 0
Turkey
State/province [246] 0 0
Kayseri
Country [247] 0 0
Turkey
State/province [247] 0 0
Istanbul
Country [248] 0 0
Turkey
State/province [248] 0 0
Mersin
Country [249] 0 0
Turkey
State/province [249] 0 0
Yenimahalle
Country [250] 0 0
Ukraine
State/province [250] 0 0
Vinnytska Oblast
Country [251] 0 0
Ukraine
State/province [251] 0 0
Dnipro
Country [252] 0 0
Ukraine
State/province [252] 0 0
Kharkiv
Country [253] 0 0
Ukraine
State/province [253] 0 0
Kropyvnytskyi
Country [254] 0 0
Ukraine
State/province [254] 0 0
Kyiv
Country [255] 0 0
Ukraine
State/province [255] 0 0
Lviv
Country [256] 0 0
Ukraine
State/province [256] 0 0
Odesa
Country [257] 0 0
Ukraine
State/province [257] 0 0
Vinnytsia
Country [258] 0 0
United Kingdom
State/province [258] 0 0
Devon
Country [259] 0 0
United Kingdom
State/province [259] 0 0
Essex
Country [260] 0 0
United Kingdom
State/province [260] 0 0
London, City Of
Country [261] 0 0
United Kingdom
State/province [261] 0 0
Scotland
Country [262] 0 0
United Kingdom
State/province [262] 0 0
Bath
Country [263] 0 0
United Kingdom
State/province [263] 0 0
Birmingham
Country [264] 0 0
United Kingdom
State/province [264] 0 0
Huddersfield
Country [265] 0 0
United Kingdom
State/province [265] 0 0
Tooting

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

Ethics approval
Ethics application status

Summary
Brief summary
This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was 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/study/NCT02819635
Trial related presentations / publications
Danese S, Vermeire S, Zhou W, Pangan AL, Siffledeen J, Greenbloom S, Hebuterne X, D'Haens G, Nakase H, Panes J, Higgins PDR, Juillerat P, Lindsay JO, Loftus EV Jr, Sandborn WJ, Reinisch W, Chen MH, Sanchez Gonzalez Y, Huang B, Xie W, Liu J, Weinreich MA, Panaccione R. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022 Jun 4;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5. Epub 2022 May 26. Erratum In: Lancet. 2022 Sep 24;400(10357):996. doi: 10.1016/S0140-6736(22)01069-8.
Sandborn WJ, Ghosh S, Panes J, Schreiber S, D'Haens G, Tanida S, Siffledeen J, Enejosa J, Zhou W, Othman AA, Huang B, Higgins PDR. Efficacy of Upadacitinib in a Randomized Trial of Patients With Active Ulcerative Colitis. Gastroenterology. 2020 Jun;158(8):2139-2149.e14. doi: 10.1053/j.gastro.2020.02.030. Epub 2020 Feb 22. Erratum In: Gastroenterology. 2020 Sep;159(3):1192. doi: 10.1053/j.gastro.2020.08.040.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02819635