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Janus Kinase (JAK) Inhibitor

Upadacitinib for Ulcerative Colitis

Phase 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Awards & highlights

Study Summary

This trial will assess the safety and effectiveness of Upadacitinib in treating pediatric UC. It will involve 2 periods, 8 wk induction, 44 wk double-blind maintenance, 260 wk open-label extension. 110 participants worldwide will take part.

Who is the study for?

This trial is for pediatric patients with moderate to severely active Ulcerative Colitis who haven't responded well to other treatments like corticosteroids, immunosuppressants, or biologics. They must have certain levels of disease activity and inflammation in the colon. Pregnant or breastfeeding individuals, or those planning pregnancy during the study period are excluded, as are those previously treated with JAK inhibitors.Check my eligibility

What is being tested?

The trial tests Upadacitinib's safety and effectiveness in children with UC over two periods: an initial 8-week phase where everyone knows they're getting the drug followed by a 44-week phase where participants don't know their dose. This leads into a long-term extension for monitoring. The treatment involves daily oral tablets or solution.See study design

What are the potential side effects?

While not explicitly listed here, common side effects of Upadacitinib may include infections due to immune system suppression, increased cholesterol levels, liver enzyme elevations indicating potential liver injury, gastrointestinal perforations (holes), and allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Achieving AMS Clinical Remission Among Week 8 Responders per AMS (Period 1)

Percentage of Participants Achieving Adapted Mayo score (AMS) Clinical Remission (Period 1)

Secondary outcome measures

Percentage of Participants Achieving AMS Clinical Remission Among Week 8 Remitters per AMS (Period 1)

Percentage of Participants Achieving AMS Clinical Response (Period 1)

Percentage of Participants Achieving AMS Clinical Response Among Week 8 Responders per AMS (Period 1)

+6 more

Side effects data

From 2023 Phase 3 trial • 613 Patients • NCT03086343

URINARY TRACT INFECTION

UPPER RESPIRATORY TRACT INFECTION

NASOPHARYNGITIS

HYPERTENSION

100%

80%

60%

40%

20%

Study treatment Arm

Abatacept

Upadacitinib 15 mg

Trial Design

5Treatment groups

Experimental Treatment

Group I: Period 2- Open Label Long Term Extension Phase Arm BExperimental Treatment1 Intervention

Clinical non-responders in US after Period 1 induction phase or clinical responders with loss of response during maintenance phase will receive upadacitinib Dose B daily for up to 260 weeks in OLE Period 2.

Group II: Period 2- Open Label Long Term Extension Phase Arm AExperimental Treatment1 Intervention

Clinical non-responders outside of US after Period 1 induction phase will receive upadacitinib Dose A daily for 8 week extended induction phase in open label long term extension (OLE) Period 2. Clinical responders from extended induction phase in OLE will receive upadacitinib Dose B daily for up to 252 weeks in OLE period 2.

Group III: Period 2- Long Term Extension Phase Arm CExperimental Treatment1 Intervention

Clinical responders who complete Period 1 through Week 52 will receive upadacitinib Dose C daily for up to 260 weeks in OLE Period 2.

Group IV: Period 1- Open Label Induction PhaseExperimental Treatment1 Intervention

All participants in open label induction phase of Period 1 will receive upadacitinib Dose A for 8 weeks based on body weight.

Group V: Period 1- Double Blind Maintenance PhaseExperimental Treatment1 Intervention

Clinical responders at the end of open label induction phase of Period 1 will be randomly assigned to receive either upadacitinib Dose B or Dose C for 44 weeks based on body weight.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Upadacitinib

2014

Completed Phase 3

~9670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

502,280 Total Patients Enrolled

30 Trials studying Ulcerative Colitis

21,344 Patients Enrolled for Ulcerative Colitis

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

146,999 Total Patients Enrolled

16 Trials studying Ulcerative Colitis

16,230 Patients Enrolled for Ulcerative Colitis

Media Library

Upadacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05782907 — Phase 3

Ulcerative Colitis Research Study Groups: Period 1- Open Label Induction Phase, Period 1- Double Blind Maintenance Phase, Period 2- Open Label Long Term Extension Phase Arm A, Period 2- Open Label Long Term Extension Phase Arm B, Period 2- Long Term Extension Phase Arm C

Ulcerative Colitis Clinical Trial 2023: Upadacitinib Highlights & Side Effects. Trial Name: NCT05782907 — Phase 3

Upadacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05782907 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accept participants of advanced age?

"This trial is seeking to enroll patients aged between 2 and 17 years old. Accordingly, 75 studies have been designed for those younger than 18, and 361 are being run for individuals 65 or older."

Answered by AI

Has the FDA sanctioned Period 1- Open Label Induction Phase?

"The safety of Period 1- Open Label Induction Phase has been rated 3 out of a possible 3, as the trial is in its third phase and there is substantial evidence to support both efficacy and security."

Answered by AI

In what geographic locations is this trial currently being conducted?

"This trial is taking place across 63 different medical centres, located in cities such as Charlotte, Cleveland and the Autonomous City of Buenos Aires. To reduce participant burden, it might be beneficial to select a site closest to you for enrollment."

Answered by AI

Are there any vacancies open to participants in this trial?

"At the current time, clinicaltrials.gov states that this trial is not seeking subjects for participation. The post was initially published on May 11th 2023 and last updated March 13th 2023. Despite its inactivity, there are 424 other active studies recruiting patients now."

Answered by AI

Who is eligible to partake in this experiment?

"The requirements to be accepted into this clinical trial are a diagnosis of ulcerative colitis and an age between 2-17. This research is scheduled to have 110 participants in total."

Answered by AI

What are the key aims of this medical experiment?

"The prime aim of this clinical trial, to be evaluated around Week 52, is the Percentage of Participants Achieving Adapted Mayo score (AMS) Clinical Remission (Period 1). Secondary objectives comprise: Percentage of Patients Attaining PMS Clinical Remission Among Week 8 Responders according to AMS (Period 1), indicated as a Mayo score that ranks illness activity for ulcerative colitis with scores ranging from 0-9 and PMS clinical remission defined as a PMS ≤ 2 and no individual subscore >1; Percentage of Participants Obtaining Partial Mayo Score (PMS) Clinical Remission (Period 1),"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.

2023. "Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05782907.

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