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A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433

NCT03345823•AbbVie

View on ClinicalTrials.gov

Summary

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For Substudy 1:
•Participant who achieve clinical response in Study M14-431 or Study M14-433.
•Participant completes study procedures in the parent study. The final endoscopy for Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.
•For Substudy 2:
•Participant completes Substudy 1. The Week 52 endoscopy may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.
•Participant who achieved clinical response at the time described in the protocol and completes study procedures in the parent study/ substudy.

Exclusion Criteria

•For Substudies 1 and 2:
•Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
•Participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Studies M14-431 and M14-433 or Substudy 1 or 2 of Study M14-430 that in the investigator's judgment makes the participant unsuitable for this study.
•Participant at the final visit of M14-431 or M14-433 with any active or chronic recurring infections based on the investigator's assessment that makes the participant an unsuitable candidate for the study. Participants with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is resolved, based on the investigator's assessment.
•Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Studies M14-431, M14-433 or Substudy 1 of Study M14-430 (Week 52).

Locations (466)

East View Medical Research, LLC /ID# 171132

Mobile, Alabama, United States

CB Flock Research Corporation /ID# 166239

Mobile, Alabama, United States

Delsol Research Management, Ll /Id# 170164

Chandler, Arizona, United States

Duplicate_HonorHealth Research Institute - Shea /ID# 164725

Scottsdale, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC /ID# 164702

Sun City, Arizona, United States

Southern California Res. Ctr. /ID# 169653

Coronado, California, United States

Citrus Valley Gastroenterology /ID# 166230

Covina, California, United States

Hoag Memorial Hosp Presbyterian /ID# 222538

Irvine, California, United States

UC San Diego Health System /ID# 164763

La Jolla, California, United States

United Medical Doctors /ID# 207458

Los Alamitos, California, United States

Key Dates

Start Date

March 21, 2018

Primary Completion Date

September 1, 2027

Completion Date

September 1, 2027

Last Updated

August 5, 2025

Enrollment

747

ESTIMATED participants

Conditions

Crohn's Disease

Interventions

Upadacitinib

DRUG

Placebo for Upadacitinib

DRUG

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

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RECRUITINGPHASE3

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931

Crohn's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

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