Upadacitinib for Ulcerative Colitis

(U-ACTIVATE Trial)

Not currently recruiting at 975 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called Upadacitinib to determine its safety and effectiveness for people with ulcerative colitis (UC) who did not respond to previous treatments or experienced a loss of response. Participants will receive varying doses of Upadacitinib or a placebo to identify the best option. It suits those who participated in earlier related studies and still experience UC symptoms affecting their daily lives. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment for UC.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that upadacitinib has been tested for safety in people with ulcerative colitis (UC). Studies have found that its safety remains stable over long-term use, with no new or unexpected safety concerns compared to earlier research.

However, serious infections have been reported with upadacitinib. Some patients may face a higher risk of infections that could require hospitalization. Despite this, earlier studies found that upadacitinib was effective and generally safe for people with UC, with many experiencing remission within the first few months of treatment.

Overall, while upadacitinib appears promising, potential participants should consider these safety details and discuss them with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Upadacitinib for ulcerative colitis because it offers a new approach by targeting specific enzymes involved in inflammation, known as Janus kinases (JAKs). Unlike standard treatments such as mesalamine or corticosteroids, which broadly suppress inflammation, Upadacitinib specifically inhibits JAK1, potentially reducing side effects while maintaining effectiveness. This targeted action might offer quicker relief and improved quality of life for patients struggling with ulcerative colitis.

What evidence suggests that Upadacitinib could be an effective treatment for ulcerative colitis?

Research has shown that upadacitinib effectively treats ulcerative colitis (UC). Studies indicate that upadacitinib helps many patients achieve clinical remission, significantly improving or eliminating symptoms. One study found that nearly half of the patients felt better within 2 to 6 weeks, with this number rising to over 70% by 12 to 16 weeks. Long-term evidence suggests that upadacitinib remains effective and safe for up to three years in patients with moderate to severe UC. These findings support upadacitinib as a promising treatment for UC. Participants in this trial will receive different doses of upadacitinib or a placebo to further evaluate its effectiveness and safety. ^{5 6 7 8 9}

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

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40217680/

Real-World Effectiveness and Safety of Upadacitinib in ...

Clinical remission was achieved in 48.3%, 71.1%, and 64.6% of patients at weeks 2 to 6, 12 to 16, and 24 to 36, respectively. Response was ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2468125325000172

Long-term efficacy and safety of upadacitinib in patients ...

Our findings show a favourable risk–benefit profile of upadacitinib in patients with moderately to severely active ulcerative colitis through 3 years of ...

3.

academic.oup.com

academic.oup.com/ecco-jcc/article/19/Supplement_1/i1260/7968004

P0642 Assessment of the real-world effectiveness of ...

In a real-world global setting, UPA demonstrated significant efficacy in reducing disease activity, severity and UC-related symptoms over time.

4.

cghjournal.org

cghjournal.org/article/S1542-3565(25)00639-1/fulltext

Comparative effectiveness of tofacitinib versus upadacitinib ...

Upadacitinib showed higher early response rates, but long-term outcomes were comparable for both. Implications for patient care. Tofacitinib and ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39709985/

Upadacitinib induction is effective and safe in ulcerative ...

Upadacitinib resulted in high rates of clinical remission at 8 and 16 weeks in this large real-world cohort of ulcerative colitis patients.

6.

thelancet.com

thelancet.com/journals/langas/article/PIIS2468-1253(23)00271-6/fulltext

Further efficacy and safety data for maintenance ...

The additional safety data of upadacitinib in ulcerative colitis presented here is particularly significant considering the findings from ...

7.

academic.oup.com

academic.oup.com/ecco-jcc/article/17/Supplement_1/i644/7009925

P518 Safety of upadacitinib in ulcerative colitis: Long-term ...

The ongoing safety profile of UPA is consistent with previous analyses, with no new safety signals identified compared with previous UC analyses ...

8.

rinvoqhcp.com

rinvoqhcp.com/dermatology/safety

RINVOQ® (upadacitinib) Safety Data

SERIOUS INFECTIONS. Patients treated with RINVOQ are at increased risk for developing infections that may lead to hospitalization or death. · MORTALITY.

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02819635

NCT02819635 | A Study to Evaluate the Safety and ...

Efficacy and safety of upadacitinib maintenance therapy for moderately to severely active ulcerative colitis in patients responding to 8 week induction ...