Upadacitinib for Ulcerative Colitis

(RESCUE UC Trial)

Overseen By Neeraj Narula

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: McMaster University

Must not be taking: CYP3A4 inhibitors/inducers

Disqualifiers: Age > 65, Infections, Thrombosis, 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: 16 weeks

134 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to examine patients with acute severe UC who are refractory to intravenous corticosteroids and determine whether a strategy of using upadacitinib first followed by infliximab in upadacitinib non-responders is non-inferior to conventional management with infliximab only.

Are You a Good Fit for This Trial?

This trial is for hospitalized patients with a confirmed diagnosis of acute severe ulcerative colitis who haven't improved after at least three days on IV steroids. Participants must have had recent colonoscopy or sigmoidoscopy, be able to follow study procedures, and provide written consent.

Inclusion Criteria

Provided written informed consent

Subject is willing and able to adhere to study procedures

I am an adult under 65 with ulcerative colitis and not pregnant or breastfeeding.

Exclusion Criteria

I am older than 65.

I have active tuberculosis.

HBV/HCV positive

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Upadacitinib 45mg daily for at least five days, followed by infliximab in non-responders, or standard care with infliximab

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Upadacitinib

Trial Overview The study tests if using upadacitinib first, then infliximab for non-responders, is as effective as the standard treatment with infliximab alone in patients with steroid-refractory acute severe ulcerative colitis.

How Is the Trial Designed?

Group I: Infliximab (standard care) Active Control 1 Intervention

Participants will receive standard care, which is Infliximab.

Group II: Upadacitinib (treatment arm) Active Control 1 Intervention

Participants will receive Upadacitinib 45mg daily, once a day, for at least five days.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

AbbVie

Industry 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