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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03653026




Registration number
NCT03653026
Ethics application status
Date submitted
28/08/2018
Date registered
31/08/2018
Date last updated
2/03/2022

Titles & IDs
Public title
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
2016-000642-62
Secondary ID [2] 0 0
M14-675
Universal Trial Number (UTN)
Trial acronym
U-Accomplish
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

Experimental: Upadacitinib 45 mg - Participants received 45 mg upadacitinib once daily (QD) for 8 weeks. Participants who did not achieve clinical response per Adapted Mayo score at Week 8 received upadacitinib 45 mg once daily for 8 additional weeks in the open-label extension period.

Placebo Comparator: Placebo - Participants received placebo matching to upadacitinib once daily for 8 weeks. Participants who did not achieve clinical response per Adapted Mayo score at Week 8 received upadacitinib 45 mg once daily for 8 weeks in the open-label extension period.


Treatment: Drugs: Placebo
Tablet for oral administration

Treatment: Drugs: Upadacitinib
Tablet for oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
Timepoint [1] 0 0
Week 8
Secondary outcome [1] 0 0
Percentage of Participants With Endoscopic Improvement at Week 8
Timepoint [1] 0 0
Week 8
Secondary outcome [2] 0 0
Percentage of Participants With Endoscopic Remission at Week 8
Timepoint [2] 0 0
Week 8
Secondary outcome [3] 0 0
Percentage of Participants Who Achieved Clinical Response Per Adapted Mayo Score at Week 8
Timepoint [3] 0 0
Week 8
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved Clinical Response Per Partial Adapted Mayo Score at Week 2
Timepoint [4] 0 0
Week 2
Secondary outcome [5] 0 0
Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8
Timepoint [5] 0 0
Week 8
Secondary outcome [6] 0 0
Percentage of Participants Who Reported No Bowel Urgency at Week 8
Timepoint [6] 0 0
Week 8
Secondary outcome [7] 0 0
Percentage of Participants Who Reported No Abdominal Pain at Week 8
Timepoint [7] 0 0
Week 8
Secondary outcome [8] 0 0
Percentage of Participants Who Achieved Histologic Improvement at Week 8
Timepoint [8] 0 0
Week 8
Secondary outcome [9] 0 0
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 8
Timepoint [9] 0 0
Baseline (Week 0) to Week 8
Secondary outcome [10] 0 0
Percentage of Participants Who Achieved Mucosal Healing at Week 8
Timepoint [10] 0 0
Week 8
Secondary outcome [11] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 8
Timepoint [11] 0 0
Baseline (Week 0) to Week 8

Eligibility
Key inclusion criteria
- Male or female participants = 16 and = 75 years of age at Baseline 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 authorities.

Note: Adolescent participants at the age of 16 or 17 years old must weigh = 40 kilograms
and meet the definition of Tanner Stage 5 at the Screening Visit.

- Diagnosis of Ulcerative Colitis (UC) 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 UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to
3.

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

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 as defined above.

- 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.

- If female, participant must meet the contraception recommendation criteria.
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 who received azathioprine or 6-mercaptopurine (6-MP) 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 prespecified abnormal hematologic
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/01/2021
Sample size
Target
Accrual to date
Final
522
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Macquarie University Hospital /ID# 211955 - Macquarie University
Recruitment hospital [2] 0 0
Duplicate_Mater Misericordiae /ID# 212687 - South Brisbane
Recruitment hospital [3] 0 0
Griffith University /ID# 211956 - Southport
Recruitment hospital [4] 0 0
St Vincent's Hospital Melbourne /ID# 205758 - Fitzroy
Recruitment hospital [5] 0 0
Monash Medical Centre /ID# 206486 - Melbourne
Recruitment hospital [6] 0 0
Fiona Stanley Hospital /ID# 211642 - Murdoch
Recruitment postcode(s) [1] 0 0
2109 - Macquarie University
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
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4222 - Southport
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3065 - Fitzroy
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3168 - Melbourne
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6150 - Murdoch
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Basel
Country [201] 0 0
Switzerland
State/province [201] 0 0
Bern
Country [202] 0 0
Switzerland
State/province [202] 0 0
Zurich
Country [203] 0 0
Taiwan
State/province [203] 0 0
Taichung
Country [204] 0 0
Taiwan
State/province [204] 0 0
Taipei
Country [205] 0 0
Taiwan
State/province [205] 0 0
Kaohsiung
Country [206] 0 0
Taiwan
State/province [206] 0 0
Taipei City
Country [207] 0 0
Turkey
State/province [207] 0 0
Kayseri
Country [208] 0 0
Turkey
State/province [208] 0 0
Ankara GAZI
Country [209] 0 0
Turkey
State/province [209] 0 0
Istanbul
Country [210] 0 0
Turkey
State/province [210] 0 0
Mersin
Country [211] 0 0
Ukraine
State/province [211] 0 0
Kharkivska Oblast
Country [212] 0 0
Ukraine
State/province [212] 0 0
Kyivska Oblast
Country [213] 0 0
Ukraine
State/province [213] 0 0
Kropyvnytskyi
Country [214] 0 0
Ukraine
State/province [214] 0 0
Kyiv
Country [215] 0 0
Ukraine
State/province [215] 0 0
Vinnytsia
Country [216] 0 0
United Kingdom
State/province [216] 0 0
Basingstoke
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Glasgow
Country [218] 0 0
United Kingdom
State/province [218] 0 0
Huddersfield
Country [219] 0 0
United Kingdom
State/province [219] 0 0
London
Country [220] 0 0
United Kingdom
State/province [220] 0 0
Whitechapel

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

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared
to placebo in inducing clinical remission (per Adapted Mayo score) in participants with
moderately to severely active ulcerative colitis (UC).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03653026
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03653026