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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02365649




Registration number
NCT02365649
Ethics application status
Date submitted
16/02/2015
Date registered
19/02/2015
Date last updated
27/12/2023

Titles & IDs
Public title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Upadacitinib (ABT-494) for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy
Secondary ID [1] 0 0
2014-003240-12
Secondary ID [2] 0 0
M13-740
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code

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

Active comparator: Induction Period ABT-494 Twice Daily Medium/High Dose - Induction Period ABT-494 Twice Daily Medium/High Dose orally dosed twice a day

Active comparator: Extension Phase ABT-494 High Dose - Extension Phase ABT-494 High Dose orally dosed twice a day

Placebo comparator: Induction Period Placebo - Induction Period Placebo orally dosed twice a day

Active comparator: Induction Period ABT-494 Low Dose - Induction Period ABT-494 Low Dose orally dosed twice a day

Active comparator: Induction Period ABT-494 Once Daily Medium/High Dose - Induction Period ABT-494 Once Daily Medium/High Dose orally dosed once a day

Active comparator: Extension Phase ABT-494 Low Dose - Extension Phase ABT-494 Low Dose orally dosed twice a day

Active comparator: Induction Period ABT-494 High Dose - Induction Period ABT-494 High Dose orally dosed twice a day

Active comparator: Induction Period ABT-494 Low/Medium Dose - Induction Period ABT-494 Low/Medium Dose orally dosed twice a day

Active comparator: Extension Phase ABT-494 Medium Dose - Extension Phase ABT-494 Medium Dose orally dosed twice a day


Treatment: Drugs: Placebo
Oral Dosing

Treatment: Drugs: ABT-494
Oral Dosing
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16
Timepoint [1] 0 0
Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Primary outcome [2] 0 0
Percentage of Participants Who Achieve Clinical Remission at Week 16
Timepoint [2] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) < 150 at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Participants With a Decrease in CDAI = 70 Points From Baseline at Week 16
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Percentage of Participants Who Achieve Clinical Remission at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants Who Achieve Remission at Week 16
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Percentage of Participants Who Achieve Response at Week 16
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Percentage of Participants With Endoscopic Response at Week 12/16
Timepoint [6] 0 0
Up to Week 16 (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Secondary outcome [7] 0 0
Percentage of Participants Who Achieve Clinical Response at Week 16
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
Percentage of Participants With an Average Daily Stool Frequency = 2.5 AND Average Daily Abdominal Pain = 2.0 at Baseline Who Achieve Clinical Remission at Week 16
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 at Week 16
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Remission at Week 12/16 and Clinical Remission at Week 16
Timepoint [10] 0 0
Up to Week 16. (At Baseline, subjects were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Secondary outcome [11] 0 0
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission at Week 16
Timepoint [11] 0 0
Week 16
Secondary outcome [12] 0 0
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 12/16
Timepoint [12] 0 0
Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Secondary outcome [13] 0 0
Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase
Timepoint [13] 0 0
Baseline, Week 4, Week 16
Secondary outcome [14] 0 0
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 16
Timepoint [14] 0 0
Baseline, Week 16
Secondary outcome [15] 0 0
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase
Timepoint [15] 0 0
Baseline, Week 8, Week 16
Secondary outcome [16] 0 0
Percentage of Participants With Isolated Ileal Crohn's Disease at Baseline Who Achieve Remission at Week 16
Timepoint [16] 0 0
Week 16
Secondary outcome [17] 0 0
Percentage of Participants With a Decrease in CDAI = 100 Points From Baseline at Week 16
Timepoint [17] 0 0
Week 16
Secondary outcome [18] 0 0
Percentage of Participants Who Achieve > 50% Reduction From Baseline in SES-CD or Endoscopic Remission at Week 12/16
Timepoint [18] 0 0
Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Secondary outcome [19] 0 0
Percentage of Participants Who Achieve Modified Clinical Remission at Week 16 Among Participants With an Average Daily Stool Frequency = 4.0 or Average Daily Abdominal Pain = 2.0 at Baseline
Timepoint [19] 0 0
Week 16
Secondary outcome [20] 0 0
Change From Baseline in Abdominal Pain Rating Scale at Week 12
Timepoint [20] 0 0
Baseline, Week 12
Secondary outcome [21] 0 0
Change From Baseline in Abdominal Pain Rating Scale at Week 16
Timepoint [21] 0 0
Baseline, Week 16
Secondary outcome [22] 0 0
Percentage of Participants Who Achieve Remission at Week 52
Timepoint [22] 0 0
Week 52
Secondary outcome [23] 0 0
Percentage of Participants Who Achieve Endoscopic Remission at Week 52
Timepoint [23] 0 0
Week 52
Secondary outcome [24] 0 0
Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency = 4.0 or Daily Abdominal Pain = 2.0 at Induction Baseline
Timepoint [24] 0 0
Week 52
Secondary outcome [25] 0 0
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Timepoint [25] 0 0
Week 20, Week 28, Week 36, Week 44, Week 52
Secondary outcome [26] 0 0
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Timepoint [26] 0 0
Week 20, Week 28, Week 36, Week 44, Week 52
Secondary outcome [27] 0 0
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency = 4.0 or Daily Abdominal Pain = 2.0 at Induction Baseline
Timepoint [27] 0 0
Week 20, Week 28, Week 36, Week 44, Week 52
Secondary outcome [28] 0 0
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency = 4.0 or Daily Abdominal Pain = 2.0 at Induction Baseline
Timepoint [28] 0 0
Week 20, Week 28, Week 36, Week 44, Week 52
Secondary outcome [29] 0 0
Percentage of Participants Who Achieve Response at Week 52
Timepoint [29] 0 0
Week 52
Secondary outcome [30] 0 0
Percentage of Participants With SES-CD = 2 at Week 52
Timepoint [30] 0 0
Week 52
Secondary outcome [31] 0 0
Percentage of Participants With SES-CD = 0 at Week 52
Timepoint [31] 0 0
Week 52
Secondary outcome [32] 0 0
Percentage of Participants Who Achieve Endoscopic Response at Week 52
Timepoint [32] 0 0
Week 52
Secondary outcome [33] 0 0
Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52
Timepoint [33] 0 0
Week 52
Secondary outcome [34] 0 0
Percentage of Participants Who Achieve Endoscopic Improvement at Week 52
Timepoint [34] 0 0
Week 52
Secondary outcome [35] 0 0
Percentage of Participants Who Achieve Endoscopic Healing at Week 52
Timepoint [35] 0 0
Week 52
Secondary outcome [36] 0 0
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Timepoint [36] 0 0
Week 20, Week 28, Week 36, Week 44, Week 52
Secondary outcome [37] 0 0
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Timepoint [37] 0 0
Week 20, Week 28, Week 36, Week 44, Week 52

Eligibility
Key inclusion criteria
1. Diagnosis of Crohn's disease (CD) for at least 90 days.
2. Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450.
3. Subject inadequately responded to or experienced intolerance to previous treatment with immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) and/or anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects with ulcerative colitis (UC), collagenous colitis or indeterminate colitis.
2. Subject who has had surgical bowel resections in the past 6 months or is planning resection.
3. Subjects with an ostomy or ileoanal pouch.
4. Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
5. Subject who has short bowel syndrome.
6. Subject with recurring infections or active Tuberculosis (TB).

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
17/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/08/2017
Sample size
Target
Accrual to date
Final
220
Recruitment in Australia
Recruitment state(s)

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

Ethics approval
Ethics application status

Summary
Brief summary
To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.
Trial website
https://clinicaltrials.gov/study/NCT02365649
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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/NCT02365649