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
2 other identifiers
interventional
220
0 countries
N/A
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2015
CompletedFirst Posted
Study publicly available on registry
February 19, 2015
CompletedStudy Start
First participant enrolled
March 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2017
CompletedResults Posted
Study results publicly available
August 14, 2023
CompletedDecember 27, 2023
December 1, 2023
1.7 years
February 16, 2015
June 5, 2023
December 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16
Endoscopic remission was determined using Simplified Endoscopic Score for Crohn's Disease (SES-CD). SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable.
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.)
Percentage of Participants Who Achieve Clinical Remission at Week 16
Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Week 16
Secondary Outcomes (54)
Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) < 150 at Week 16
Week 16
Percentage of Participants With a Decrease in CDAI ≥ 70 Points From Baseline at Week 16
Week 16
Percentage of Participants Who Achieve Clinical Remission at Week 12
Week 12
Percentage of Participants Who Achieve Remission at Week 16
Week 16
Percentage of Participants Who Achieve Response at Week 16
Week 16
- +49 more secondary outcomes
Study Arms (9)
Induction Period ABT-494 Twice Daily Medium/High Dose
ACTIVE COMPARATORInduction Period ABT-494 Twice Daily Medium/High Dose orally dosed twice a day
Extension Phase ABT-494 High Dose
ACTIVE COMPARATORExtension Phase ABT-494 High Dose orally dosed twice a day
Induction Period Placebo
PLACEBO COMPARATORInduction Period Placebo orally dosed twice a day
Induction Period ABT-494 Low Dose
ACTIVE COMPARATORInduction Period ABT-494 Low Dose orally dosed twice a day
Induction Period ABT-494 Once Daily Medium/High Dose
ACTIVE COMPARATORInduction Period ABT-494 Once Daily Medium/High Dose orally dosed once a day
Extension Phase ABT-494 Low Dose
ACTIVE COMPARATORExtension Phase ABT-494 Low Dose orally dosed twice a day
Induction Period ABT-494 High Dose
ACTIVE COMPARATORInduction Period ABT-494 High Dose orally dosed twice a day
Induction Period ABT-494 Low/Medium Dose
ACTIVE COMPARATORInduction Period ABT-494 Low/Medium Dose orally dosed twice a day
Extension Phase ABT-494 Medium Dose
ACTIVE COMPARATORExtension Phase ABT-494 Medium Dose orally dosed twice a day
Interventions
Oral Dosing
Eligibility Criteria
You may qualify if:
- Diagnosis of Crohn's disease (CD) for at least 90 days.
- Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450.
- 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).
You may not qualify if:
- Subjects with ulcerative colitis (UC), collagenous colitis or indeterminate colitis.
- Subject who has had surgical bowel resections in the past 6 months or is planning resection.
- Subjects with an ostomy or ileoanal pouch.
- Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
- Subject who has short bowel syndrome.
- Subject with recurring infections or active Tuberculosis (TB).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Related Publications (4)
Sandborn WJ, Lewis JD, Panes J, Loftus EV, D'Haens G, Yu Z, Huang B, Lacerda AP, Pangan AL, Feagan BG. Association Between Proposed Definitions of Clinical Remission/Response and Well-Being in Patients With Crohn's Disease. J Crohns Colitis. 2022 Mar 14;16(3):444-451. doi: 10.1093/ecco-jcc/jjab161.
PMID: 34546360DERIVEDAguilar D, Revilla L, Garrido-Trigo A, Panes J, Lozano JJ, Planell N, Esteller M, Lacerda AP, Guay H, Butler J, Davis JW, Salas A. Randomized Controlled Trial Substudy of Cell-specific Mechanisms of Janus Kinase 1 Inhibition With Upadacitinib in the Crohn's Disease Intestinal Mucosa: Analysis From the CELEST Study. Inflamm Bowel Dis. 2021 Nov 15;27(12):1999-2009. doi: 10.1093/ibd/izab116.
PMID: 34042156DERIVEDPeyrin-Biroulet L, Louis E, Loftus EV Jr, Lacerda A, Zhou Q, Sanchez Gonzalez Y, Ghosh S. Quality of Life and Work Productivity Improvements with Upadacitinib: Phase 2b Evidence from Patients with Moderate to Severe Crohn's Disease. Adv Ther. 2021 May;38(5):2339-2352. doi: 10.1007/s12325-021-01660-7. Epub 2021 Mar 23.
PMID: 33755884DERIVEDSandborn WJ, Feagan BG, Loftus EV Jr, Peyrin-Biroulet L, Van Assche G, D'Haens G, Schreiber S, Colombel JF, Lewis JD, Ghosh S, Armuzzi A, Scherl E, Herfarth H, Vitale L, Mohamed MF, Othman AA, Zhou Q, Huang B, Thakkar RB, Pangan AL, Lacerda AP, Panes J. Efficacy and Safety of Upadacitinib in a Randomized Trial of Patients With Crohn's Disease. Gastroenterology. 2020 Jun;158(8):2123-2138.e8. doi: 10.1053/j.gastro.2020.01.047. Epub 2020 Feb 8.
PMID: 32044319DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2015
First Posted
February 19, 2015
Study Start
March 17, 2015
Primary Completion
November 25, 2016
Study Completion
August 3, 2017
Last Updated
December 27, 2023
Results First Posted
August 14, 2023
Record last verified: 2023-12