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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

NCT ID: NCT02365649

Last Updated: 2023-12-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-17

Study Completion Date

2017-08-03

Brief Summary

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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.

Detailed Description

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Conditions

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Crohn's Disease

Keywords

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Induction Period ABT-494 Twice Daily Medium/High Dose

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

Group Type ACTIVE_COMPARATOR

ABT-494

Intervention Type DRUG

Oral Dosing

Extension Phase ABT-494 High Dose

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

Group Type ACTIVE_COMPARATOR

ABT-494

Intervention Type DRUG

Oral Dosing

Induction Period Placebo

Induction Period Placebo orally dosed twice a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral Dosing

Induction Period ABT-494 Low Dose

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

Group Type ACTIVE_COMPARATOR

ABT-494

Intervention Type DRUG

Oral Dosing

Induction Period ABT-494 Once Daily Medium/High Dose

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

Group Type ACTIVE_COMPARATOR

ABT-494

Intervention Type DRUG

Oral Dosing

Extension Phase ABT-494 Low Dose

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

Group Type ACTIVE_COMPARATOR

ABT-494

Intervention Type DRUG

Oral Dosing

Induction Period ABT-494 High Dose

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

Group Type ACTIVE_COMPARATOR

ABT-494

Intervention Type DRUG

Oral Dosing

Induction Period ABT-494 Low/Medium Dose

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

Group Type ACTIVE_COMPARATOR

ABT-494

Intervention Type DRUG

Oral Dosing

Extension Phase ABT-494 Medium Dose

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

Group Type ACTIVE_COMPARATOR

ABT-494

Intervention Type DRUG

Oral Dosing

Interventions

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Placebo

Oral Dosing

Intervention Type DRUG

ABT-494

Oral Dosing

Intervention Type DRUG

Other Intervention Names

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Upadacitinib

Eligibility Criteria

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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).

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Countries

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Australia Belgium Canada Czechia Denmark France Germany Hungary Israel Italy Netherlands New Zealand Norway Poland Puerto Rico Romania Slovakia Spain Sweden United Kingdom United States

References

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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.

Reference Type DERIVED
PMID: 34546360 (View on PubMed)

Aguilar 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.

Reference Type DERIVED
PMID: 34042156 (View on PubMed)

Peyrin-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.

Reference Type DERIVED
PMID: 33755884 (View on PubMed)

Sandborn 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.

Reference Type DERIVED
PMID: 32044319 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2014-003240-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M13-740

Identifier Type: -

Identifier Source: org_study_id