A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Study Description

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Brief Summary:

This study comprises three sub-studies. The objective of sub-study 1 is to characterize the dose-response, efficacy, and safety of ABT-494 compared to placebo in inducing clinical remission in order to identify the induction dose of ABT-494 for further evaluation in sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of ABT-494 compared to placebo in inducing clinical remission in participants. The objective of sub-study 3 is to evaluate the efficacy and safety of ABT-494 compared to placebo in achieving clinical remission in participants who had a response following induction with ABT-494.

Condition or disease	Intervention/treatment	Phase
Ulcerative Colitis (UC)	Drug: Placebo; Drug: ABT-494	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1055 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Actual Study Start Date :	September 28, 2016
Estimated Primary Completion Date :	April 27, 2021
Estimated Study Completion Date :	July 30, 2021

Arms and Interventions

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Arm	Intervention/treatment
Experimental: ABT-494 Dose B; Administered orally, once daily.	Drug: ABT-494; Tablet; Other Name: Upadacitinib
Experimental: ABT-494 Dose A; Administered orally, once daily.	Drug: ABT-494; Tablet; Other Name: Upadacitinib
Experimental: ABT-494 Dose C; Administered orally, once daily.	Drug: ABT-494; Tablet; Other Name: Upadacitinib
Experimental: ABT-494 Dose D; Administered orally, once daily.	Drug: ABT-494; Tablet; Other Name: Upadacitinib
Placebo Comparator: Placebo; Administered orally, once daily.	Drug: Placebo; Tablet

Outcome Measures

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Primary Outcome Measures :

1. Substudy 1/Substudy 2: Proportion of participants who achieve clinical remission per adapted Mayo score [ Time Frame: At Week 8 ]
   Clinical remission is defined as stool frequency subscore (SFS) <= 1, rectal bleeding subscore (RBS) of 0, and endoscopic subscore <= 1.
2. Substudy 3: Proportion of participants who achieve clinical remission per adapted Mayo score [ Time Frame: At Week 44 ]
   Clinical remission is defined as stool frequency subscore (SFS) <= 1, rectal bleeding subscore (RBS) of 0, and endoscopic subscore <= 1.

Secondary Outcome Measures :

1. Substudy 3: Proportion of participants who discontinued corticosteroid use that achieved clinical remission per Adapted Mayo score at Week 44 [ Time Frame: At Week 44 ]
   Participants who discontinued corticosteroid use and achieved clinical remission per Adapted Mayo score, defined as Stool Frequency Subscore (SFS) <= 1, Rectal Bleeding Subscore (RBS) of 0, and endoscopic subscore <= 1.
2. Substudy 1/Substudy 2: Proportion of participants achieving clinical response per Adapted Mayo score at Week 8 [ Time Frame: At Week 8 ]
   Clinical response per Adapted Mayo is defined as a decrease from baseline in the Adapted Mayo score >= 2 points and >= 30% from baseline, PLUS a decrease in rectal bleeding subscore (RBS) >= 1 or an absolute RBS <= 1.
3. Substudy 3: Proportion of participants achieving clinical remission per Full Mayo score at Week 44 [ Time Frame: At Week 44 ]
   Clinical remission per Full Mayo score is defined as a Full Mayo score <= 2 with no subscore > 1
4. Substudy 1/Substudy 2: Proportion of participants achieving clinical remission per Full Mayo score at Week 8 [ Time Frame: At Week 8 ]
   Clinical remission is defined as a Full Mayo score <= 2 with no subscore > 1
5. Substudy 3: Proportion of participants with endoscopic improvement at Week 44 [ Time Frame: At Week 44 ]
   Endoscopic improvement is defined as an endoscopic subscore <= 1
6. Substudy 1/Substudy 2: Proportion of participants with endoscopic improvement at Week 8 [ Time Frame: At Week 8 ]
   Endoscopic improvement is defined as an endoscopic subscore <= 1

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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 corticosteroids, immunosuppressants, and/or biologic therapies.
• If female, participant must meet the criteria for Contraception Recommendations and Pregnancy Testing.
• 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.
• Male participants must agree to follow protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 90 days post last dose of study drug.

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, or mycophenolate mofetil 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 JAK inhibitor (e.g., tofacitinib, baricitinib, filgotinib).
• Screening laboratory and other analyses show any abnormal results.

Contacts and Locations

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Contacts

Contact: ABBVIE CALL CENTER	847.283.8955	abbvieclinicaltrials@abbvie.com

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Sponsors and Collaborators

AbbVie

Investigators

Study Director:	AbbVie Inc.	AbbVie

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	AbbVie
ClinicalTrials.gov Identifier:	NCT02819635 History of Changes
Other Study ID Numbers:	M14-234; 2016-000641-31 ( EudraCT Number )
First Posted:	June 30, 2016
Last Update Posted:	April 17, 2018
Last Verified:	April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No
Product Manufactured in and Exported from the U.S.:		No

Keywords provided by AbbVie:

ABT-494; Moderately to Severely Active UC

Additional relevant MeSH terms:

Colitis; Ulcer; Colitis, Ulcerative; Gastroenteritis; Gastrointestinal Diseases	Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Inflammatory Bowel Diseases