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Compensation: Varies

Number of Visits: Unknown

Duration: Up to 288 weeks

950 Participants Needed

Upadacitinib for Ulcerative Colitis
(U-ACHIEVE Trial)

Recruiting at 832 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Inclusion Criteria

I am following the required birth control guidelines.

Participant has not achieved clinical response at the end of the induction period (Week 8) in Study M14-234 Substudy 1, has had loss of response during the maintenance period of Study M14-234 Substudy 3, or has successfully completed Study M14-234 Substudy 3. During the COVID-19 pandemic, for participants with missing endoscopy at Week 8, Week 16 or Week 52 due to the COVID-19 pandemic in Studies M14-234 Substudy 2, M14-234 Substudy 3 and M14-675, participants may be enrolled if certain criteria are met

Must be able and willing to give written informed consent and to comply with the requirements of this study protocol

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Exclusion Criteria

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.

For any reason participant is considered by the investigator to be an unsuitable candidate

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Upadacitinib (ABT-494) or placebo to evaluate long-term safety and efficacy

Up to 288 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Upadacitinib (ABT-494)

Trial OverviewThe 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.

Participant Groups

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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

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Upadacitinib for Ulcerative Colitis (U-ACHIEVE Trial)