Upadacitinib for Ulcerative Colitis

(U-ACHIEVE Trial)

Recruiting at 832 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Active infection, Tuberculosis, Malignancy, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 288 weeks

950 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Upadacitinib (ABT-494)

Trial Overview 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.

How Is the Trial Designed?

Group I: Participants receiving Upadacitinib (ABT-494) Dose C Experimental Treatment 1 Intervention

The participants in this arm will receive Upadacitinib (ABT-494) dose C.

Group II: Participants receiving Upadacitinib (ABT-494) Dose B Experimental Treatment 1 Intervention

The participants in this arm will receive Upadacitinib (ABT-494) dose B.

Group III: Participants receiving Upadacitinib (ABT-494) Dose A or Dose B Experimental Treatment 1 Intervention

The participants in this arm will receive Upadacitinib (ABT-494) dose A or dose B.

Group IV: Participants receiving Upadacitinib (ABT-494) Dose A Experimental Treatment 1 Intervention

The participants in this arm will receive Upadacitinib (ABT-494) dose A.

Group V: Participants receiving Placebo Experimental Treatment 1 Intervention

The participants in this arm will receive placebo until study is unblinded.

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

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois