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

NCT03345823 · tracked via the Priya Life Science Ireland tracker

Sponsor

AbbVie

Phase

Phase 3

Started

2018-03-21

Last updated

2026-04-09

Condition(s) studied

Crohn's Disease

Investigational drug(s) / intervention(s)

UpadacitinibPlacebo for Upadacitinib

Upadacitinib: Oral; Tablet

Placebo for Upadacitinib: Oral; Tablet

Study 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

Sex

ALL

Min age

18 Years

Max age

75 Years

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).

Primary outcome measure(s)

Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) — Week 52
Clinical remission per CDAI is defined as CDAI \<150.
Sub-Study 1: Percentage of Participants with Endoscopic Response — Week 52
Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline.
Number of Participants with Adverse Events — Through Week 240
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section.

Trial sites (466)

Facility	City	Region
East View Medical Research, LLC /ID# 171132	Mobile	Alabama
CB Flock Research Corporation /ID# 166239	Mobile	Alabama
Delsol Research Management, Ll /Id# 170164	Chandler	Arizona
Duplicate_HonorHealth Research Institute - Shea /ID# 164725	Scottsdale	Arizona
Duplicate_Arizona Arthritis & Rheumatology Research, PLLC /ID# 164702	Sun City	Arizona
Southern California Res. Ctr. /ID# 169653	Coronado	California
Citrus Valley Gastroenterology /ID# 166230	Covina	California
Hoag Memorial Hosp Presbyterian /ID# 222538	Irvine	California
UC San Diego Health System /ID# 164763	La Jolla	California
United Medical Doctors /ID# 207458	Los Alamitos	California
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164640	Los Angeles	California
Facey Medical Foundation /ID# 203138	Mission Hills	California
United Medical Doctors - Murrieta /ID# 164602	Murrieta	California
Medical Assoc Research Grp /ID# 169704	San Diego	California
UCSF Medical Center - Mount Zion /ID# 202372	San Francisco	California
Univ of California San Francis /ID# 164653	San Francisco	California
Care Access Research /ID# 167765	San Pablo	California
Peak Gastroenterology Associates, PC /ID# 170166	Colorado Springs	Colorado
Delta Waves, Inc. /ID# 164656	Colorado Springs	Colorado
Western States Clinical Res /ID# 164625	Wheat Ridge	Colorado
Gastroenterology Center of Connecticut /ID# 164614	Hamden	Connecticut
Advanced Research - Coral Springs /ID# 218019	Coral Springs	Florida
Encore Borland-Groover Clinical Research /Id# 203500	Jacksonville	Florida
Ctr for Advanced Gastroenterol /ID# 165306	Maitland	Florida
Crystal Pharmacology Research /ID# 166118	Miami	Florida
Coral Research Clinic /ID# 164604	Miami	Florida
Advanced Research Institute, Inc /ID# 164601	New Port Richey	Florida
Endoscopic Research, Inc. /ID# 206139	Orlando	Florida
Omega Research Group /ID# 203482	Orlando	Florida
Duplicate_Clinical Research of West Florida, Inc /ID# 205828	Tampa	Florida
Duplicate_Clinical Research of West Florida, Inc /ID# 208119	Tampa	Florida
Clinical Research Trials of Florida, Inc. /ID# 203486	Tampa	Florida
Duplicate_AdventHealth Tampa /ID# 171181	Tampa	Florida
Gastroenterology Associates of Central Georgia, LLC /ID# 165492	Macon	Georgia
Gastroenterology Consultants, P.C /ID# 218218	Roswell	Georgia
Atlanta Gastroenterology Spec /ID# 164698	Suwanee	Georgia
Treasure Valley Medical Research /ID# 215030	Boise	Idaho
Duplicate_Rush University Medical Center /ID# 165470	Chicago	Illinois
Duplicate_University of Chicago Medicine /ID# 165509	Chicago	Illinois
DuPage Medical Group /ID# 205320	Downers Grove	Illinois

+ 426 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03345823 on ClinicalTrials.gov ↗ ← All trials in Ireland