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Janus Kinase (JAK) Inhibitor

Upadacitinib for Ulcerative Colitis

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 288 weeks
Awards & highlights

Study Summary

This trial will study the safety and efficacy of Upadacitinib in UC patients who haven't responded to other treatments.

Who is the study for?
This trial is for adults with Ulcerative Colitis who didn't respond to previous treatments in a related study, or completed the maintenance phase. They must be generally healthy and women should use contraception. People can't join if they're allergic to Upadacitinib, have active tuberculosis, uncontrolled health conditions like diabetes or heart disease, certain cancers, or are pregnant.Check my eligibility
What is being tested?
The trial tests the long-term safety and effectiveness of a drug called Upadacitinib in people with Ulcerative Colitis. Some participants will receive this medication while others may get a placebo (a substance with no therapeutic effect) to compare outcomes.See study design
What are the potential side effects?
Upadacitinib could cause side effects such as infections due to weakened immune response, liver issues, blood clots, and possibly an increased risk of certain cancers. The exact side effects experienced can vary from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 288 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 288 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessing Treatment-Emergent Adverse Events

Trial Design

5Treatment groups
Experimental Treatment
Group I: Participants receiving Upadacitinib (ABT-494) Dose CExperimental Treatment1 Intervention
The participants in this arm will receive Upadacitinib (ABT-494) dose C.
Group II: Participants receiving Upadacitinib (ABT-494) Dose BExperimental Treatment1 Intervention
The participants in this arm will receive Upadacitinib (ABT-494) dose B.
Group III: Participants receiving Upadacitinib (ABT-494) Dose A or Dose BExperimental Treatment1 Intervention
The participants in this arm will receive Upadacitinib (ABT-494) dose A or dose B.
Group IV: Participants receiving Upadacitinib (ABT-494) Dose AExperimental Treatment1 Intervention
The participants in this arm will receive Upadacitinib (ABT-494) dose A.
Group V: Participants receiving PlaceboExperimental Treatment1 Intervention
The participants in this arm will receive placebo until study is unblinded.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
946 Previous Clinical Trials
495,522 Total Patients Enrolled
30 Trials studying Ulcerative Colitis
20,504 Patients Enrolled for Ulcerative Colitis
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
100,607 Total Patients Enrolled
14 Trials studying Ulcerative Colitis
12,605 Patients Enrolled for Ulcerative Colitis
ABBVIE INC.Study DirectorAbbVie
387 Previous Clinical Trials
140,203 Total Patients Enrolled
16 Trials studying Ulcerative Colitis
15,390 Patients Enrolled for Ulcerative Colitis

Media Library

Upadacitinib (ABT-494) (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03006068 — Phase 3
Ulcerative Colitis Research Study Groups: Participants receiving Upadacitinib (ABT-494) Dose A, Participants receiving Upadacitinib (ABT-494) Dose B, Participants receiving Upadacitinib (ABT-494) Dose C, Participants receiving Placebo, Participants receiving Upadacitinib (ABT-494) Dose A or Dose B
Ulcerative Colitis Clinical Trial 2023: Upadacitinib (ABT-494) Highlights & Side Effects. Trial Name: NCT03006068 — Phase 3
Upadacitinib (ABT-494) (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03006068 — Phase 3

Frequently Asked Questions

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

Is this trial still enrolling patients that are relatively young?

"According to the eligibility requirements posted for this clinical trial, potential participants must be between 16 and 75 years old. There are 77 other trials available for people under 18 and 378 for seniors."

Answered by AI

Is this research being conducted for the first time?

"Upadacitinib (ABT-494) has been trialed in 21 studies since 2015, with the first being a Phase 3 sponsored by AbbVie. These trials have taken place in 953 cities and 54 countries, involving 18248 total participants."

Answered by AI

What other scientific investigations have included Upadacitinib (ABT-494)?

"Upadacitinib (ABT-494) is being investigated in 21 active studies, 14 of which are in Phase 3. The majority of clinical trials for Upadacitinib (ABT-494) are based in Hong Kong and Ciudad De Mexico, but there are a total of 3924 locations running studies on the medication."

Answered by AI

Are there any safety concerns with Upadacitinib (ABT-494)?

"Upadacitinib (ABT-494) is a medication that has demonstrated some efficacy in clinical trials and has received a score of 3 for safety."

Answered by AI

How many different sites are participating in this research project?

"There are over 100 enrolment locations for this trial, including Ctr for Gastrointestinal Healt /ID# 153369 in Franklin, Virginia, Washington Gastroenterology Associates /ID# 163630 in Bellevue, Washington, and The Ottawa Hospital /ID# 151817 in Ottawa, Ontario."

Answered by AI

Could you explain the general purpose of Upadacitinib (ABT-494)?

"Upadacitinib (ABT-494) is an effective systemic therapy for patients suffering from rheumatoid arthritis and methotrexate."

Answered by AI

Could I join this clinical research project?

"This ongoing medical trial is looking for 950 ulcer patients that meet the age criteria of 16-75. In addition, these volunteers must have not responded to prior treatments, lost response to maintenance treatment, or successfully completed study M14-234 Substudy 3. Due to the COVID-19 pandemic, participants that have missed endoscopy appointments may still be eligible for the study if they meet additional criteria. Lastly, participants must be in good health as determined by the principal investigator and must use contraception if female."

Answered by AI

Are patients able to sign up for this clinical trial at this moment?

"Unfortunately, this particular study is not recruiting patients at this time. However, there are many other trials (440) that are still looking for participants."

Answered by AI

How many individuals are currently enrolled in this trial?

"As of now, this clinical trial is no longer recruiting patients. This study was originally posted on 2017-01-31 and was last edited on 2022-01-18. However, there are 419 other clinical trials for ulcers and 21 studies regarding Upadacitinib (ABT-494) that are still looking for willing participants."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
How old are they?
18 - 65
What site did they apply to?
Atlanta Gastroenterology Spec /ID# 150565
What portion of applicants met pre-screening criteria?
Did not meet criteria
~296 spots leftby Jul 2027