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Study identifier: NCT03345823 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Active Not RecruitingU-ENDURE

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

Condition: Crohn's Disease  ·  Sponsor: AbbVie

PhasePhase 3
Planned participants747
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where466 locations · 49 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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).

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (466)

East View Medical Research, LLC /ID# 171132Mobile, Alabama, United States
CB Flock Research Corporation /ID# 166239Mobile, Alabama, United States
Delsol Research Management, Ll /Id# 170164Chandler, Arizona, United States
Duplicate_HonorHealth Research Institute - Shea /ID# 164725Scottsdale, Arizona, United States
Duplicate_Arizona Arthritis & Rheumatology Research, PLLC /ID# 164702Sun City, Arizona, United States
Southern California Res. Ctr. /ID# 169653Coronado, California, United States
Citrus Valley Gastroenterology /ID# 166230Covina, California, United States
Hoag Memorial Hosp Presbyterian /ID# 222538Irvine, California, United States
UC San Diego Health System /ID# 164763La Jolla, California, United States
United Medical Doctors /ID# 207458Los Alamitos, California, United States
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164640Los Angeles, California, United States
Facey Medical Foundation /ID# 203138Mission Hills, California, United States

+ 454 more locations — full list on the registry record.

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