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Janus Kinase Inhibitor

Upadacitinib Maintenance Therapy for Crohn's Disease

Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through week 240
Awards & highlights

Study Summary

This trial is testing a new Crohn's disease drug to see if it is effective and safe.

Who is the study for?
This trial is for adults with Crohn's Disease who showed improvement in previous studies (M14-431 or M14-433) and completed certain study procedures. Participants can still join if their final endoscopy was missed due to COVID-19.Check my eligibility
What is being tested?
The trial tests the long-term effectiveness and safety of Upadacitinib, a pill that targets specific proteins involved in inflammation, compared to a placebo in maintaining Crohn's Disease treatment effects.See study design
What are the potential side effects?
Upadacitinib may cause side effects like infections, headaches, high blood pressure, nausea, and potential liver issues. The severity of side effects varies from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through week 240
This trial's timeline: 3 weeks for screening, Varies for treatment, and through week 240 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Adverse Events
Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)
Sub-Study 1: Percentage of Participants with Endoscopic Response
Secondary outcome measures
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100)
+8 more

Side effects data

From 2023 Phase 3 trial • 613 Patients • NCT03086343
6%
URINARY TRACT INFECTION
5%
UPPER RESPIRATORY TRACT INFECTION
5%
NASOPHARYNGITIS
3%
HYPERTENSION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abatacept
Upadacitinib 15 mg

Trial Design

10Treatment groups
Experimental Treatment
Group I: Substudy 3: Cohort 6 Upadacitinib Dose AExperimental Treatment1 Intervention
This is the dose optimization group which includes participants from Substudy 2 who meet the criteria of stable remission will receive open-label upadacitinib dose A for up to 48 weeks.
Group II: Substudy 2: Cohort 5 Upadacitinib Dose BExperimental Treatment1 Intervention
This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose B for 240 weeks.
Group III: Substudy 2: Cohort 5 Upadacitinib Dose AExperimental Treatment1 Intervention
This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose A for 240 weeks.
Group IV: Substudy 2: Cohort 5 PlaceboExperimental Treatment1 Intervention
This is a long-term extension group which includes participants who complete Substudy 1 and will receive placebo for 240 weeks.
Group V: Substudy 2: Cohort 4 Upadacitinib Dose BExperimental Treatment1 Intervention
This is a long-term extension group which includes participants who achieved clinical response in the open-label extended treatment period of study M14-431 and will receive upadacitinib dose B for 240 weeks.
Group VI: Substudy 1: Cohort 3 Upadacitinib Dose BExperimental Treatment1 Intervention
This is a maintenance group which includes participants who achieved clinical response to upadacitinib from the extended treatment period of studies M14-431 and M14-433 and will receive upadacitinib Dose B for 52 Weeks.
Group VII: Substudy 1: Cohort 2 PlaceboExperimental Treatment1 Intervention
This is a maintenance group which includes participants who received double-blind placebo in studies M14-431 and M14-433 and achieved clinical response will continue to receive blinded placebo for 52 Weeks.
Group VIII: Substudy 1: Cohort 1 Upadacitinib Dose BExperimental Treatment1 Intervention
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose B for 52 weeks.
Group IX: Substudy 1: Cohort 1 Upadacitinib Dose AExperimental Treatment1 Intervention
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose A for 52 weeks.
Group X: Substudy 1: Cohort 1 PlaceboExperimental Treatment1 Intervention
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive placebo for 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo for Upadacitinib
2020
Completed Phase 3
~720
Upadacitinib
2014
Completed Phase 3
~9670

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
954 Previous Clinical Trials
500,358 Total Patients Enrolled
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
100,810 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,192 Total Patients Enrolled

Media Library

Upadacitinib (Janus Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03345823 — Phase 3
Crohn's Disease Research Study Groups: Substudy 1: Cohort 3 Upadacitinib Dose B, Substudy 2: Cohort 5 Placebo, Substudy 3: Cohort 6 Upadacitinib Dose A, Substudy 1: Cohort 2 Placebo, Substudy 1: Cohort 1 Placebo, Substudy 1: Cohort 1 Upadacitinib Dose A, Substudy 1: Cohort 1 Upadacitinib Dose B, Substudy 2: Cohort 4 Upadacitinib Dose B, Substudy 2: Cohort 5 Upadacitinib Dose B, Substudy 2: Cohort 5 Upadacitinib Dose A
Crohn's Disease Clinical Trial 2023: Upadacitinib Highlights & Side Effects. Trial Name: NCT03345823 — Phase 3
Upadacitinib (Janus Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03345823 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please list any other instances in which Upadacitinib has been studied?

"Upadacitinib was first studied in 2015 at Arthritis Clinical Research Tr /ID# 144874. So far, there have been 21 completed studies, with 21 more currently underway--a large number of these in Dallas, Texas."

Answered by AI

Is this research project currently looking for new participants?

"This particular clinical trial is no longer recruiting patients. The listing was first posted on March 21st, 2018 and was edited as recently as April 8th, 2022. There are presently 256 trials actively looking for participants with crohn disease and 21 studies for Upadacitinib actively searching for participants."

Answered by AI

What are the scientists conducting this research hoping to discover?

"The primary objective of this trial, as measured by the Crohn's disease Activity Index (CDAI), is Sub-Study 1: Percentage of Participants with Clinical Remission over a Through Week 240 time frame. Additionally, this study will assess other outcomes including Sub-Study 1: Percentage of Participants without Corticosteroid use for Crohn's Disease Among All Participants, which is defined as participants not taking corticosteroids at least 90 days prior to Week 52 and achieved clinical remission per CDAI. Clinical remission is defined as CDAI <150. Another outcome being assessed is Sub-Study 1: Percentage of Participants with"

Answered by AI

If a patient is 50 years old or younger, can they join this research project?

"Individuals that wish to apply for this clinical trial must be between 18-75 years old. There are currently 75 trials underway for patients that are below the age of 18 and 216 for those above 65."

Answered by AI

Does this clinical trial differ from others that have been conducted in the past?

"AbbVie's Upadacitinib has completed Phase 3 drug approval, having first been trialed in 2015. Since then, there have been 21 active studies in 54 countries and 953 cities."

Answered by AI

What are the most common illnesses that doctors use Upadacitinib to treat?

"Upadacitinib can be administered to patients that suffer from rheumatoid arthritis and have received methotrexate therapy."

Answered by AI

Has Upadacitinib been cleared by the FDA?

"Upadacitinib has received a Phase 3 rating, meaning that there is some efficacy data as well as multiple rounds of data supporting safety. Consequently, our team has given it a 3 in terms of safety."

Answered by AI

Who else is applying?

What state do they live in?
South Dakota
What site did they apply to?
Duplicate_Western States Clinical Res /ID# 164625
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
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
2018. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03345823.
All > Crohns Disease
~264 spots leftby Sep 2027
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