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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 288 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 288 weeks
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
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Who is running the clinical trial?
AbbVieLead Sponsor
1,019 Previous Clinical Trials
518,976 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
441 Previous Clinical Trials
159,425 Total Patients Enrolled
9 Trials studying Ulcerative Colitis
3,021 Patients Enrolled for Ulcerative Colitis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am following the required birth control guidelines.If female, participant must meet the criteria for Contraception Recommendations.My last endoscopy showed cancer or serious cell changes in my digestive tract.I have only had nonmelanoma skin cancer or localized cervical cancer, both treated successfully.I am 16 or 17 years old and can join the trial if it's allowed in my area.I am pregnant or might become pregnant during the study or within 30 days after the last dose.I am 16 or 17 years old and can join the trial if it's allowed in my area.I do not have active or untreated latent tuberculosis.I am a woman who can have children and my pregnancy test was negative.
Research Study Groups:
This trial has the following groups:- Group 1: Participants receiving Upadacitinib (ABT-494) Dose A
- Group 2: Participants receiving Upadacitinib (ABT-494) Dose B
- Group 3: Participants receiving Upadacitinib (ABT-494) Dose C
- Group 4: Participants receiving Placebo
- Group 5: Participants receiving Upadacitinib (ABT-494) Dose A or Dose B
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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