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Janus Kinase (JAK) Inhibitor

Upadacitinib for Ulcerative Colitis (U-ACHIEVE Trial)

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
Must not have
Participants have malignancy, high-grade dysplasia, un-removed low-grade dysplasia of the gastrointestinal tract diagnosed at the endoscopy performed at the final visit of Study M14-234
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 288 weeks
Awards & highlights
Pivotal Trial

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My last endoscopy showed cancer or serious cell changes in my digestive tract.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessing Treatment-Emergent Adverse Events

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
Upadacitinib (ABT-494)
2019
Completed Phase 1
~40
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,035 Previous Clinical Trials
522,094 Total Patients Enrolled
18 Trials studying Ulcerative Colitis
6,067 Patients Enrolled for Ulcerative Colitis
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
100,671 Total Patients Enrolled
6 Trials studying Ulcerative Colitis
2,500 Patients Enrolled for Ulcerative Colitis
ABBVIE INC.Study DirectorAbbVie
456 Previous Clinical Trials
162,743 Total Patients Enrolled
9 Trials studying Ulcerative Colitis
3,021 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
~236 spots leftby Jul 2027
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