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Janus Kinase (JAK) Inhibitor

Upadacitinib for Crohn's Disease

Phase 2
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If female, participant must be postmenopausal, surgically sterile or using a birth control method.
If female, participant must be postmenopausal, surgically sterile or on using a birth control method.
Must not have
Female participant with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 96
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the long-term effects of a medication called Upadacitinib. Researchers will evaluate how well the drug works, how safe it is, and how well people tolerate it.

Who is the study for?
This trial is for individuals with Crohn's Disease who have completed the M13-740 study up to Week 52. Women must be postmenopausal, surgically sterile, or using birth control. Those unsuitable as per the investigator, pregnant women, or those planning pregnancy during the study are excluded.
What is being tested?
The trial is testing Upadacitinib (ABT-494) for long-term effectiveness and safety in treating Crohn's Disease. It involves repeated doses of this medication over an extended period to monitor its sustained impact on patients.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with Upadacitinib may include infections, headaches, nausea, and potential liver issues. Long-term use will help understand the full range of possible side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman who is either postmenopausal, surgically sterile, or using birth control.
Select...
I am a woman who is postmenopausal, surgically sterile, or using birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant nor planning to become pregnant during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 96
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 96 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Achieving Clinical Remission
Percentage of Participants Achieving Clinical Response
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Remission
+16 more

Side effects data

From 2024 Phase 3 trial • 642 Patients • NCT03104374
6%
UPPER RESPIRATORY TRACT INFECTION
5%
BRONCHITIS
5%
NASOPHARYNGITIS
4%
URINARY TRACT INFECTION
4%
INFLUENZA
4%
PSORIATIC ARTHROPATHY
2%
BLOOD CREATINE PHOSPHOKINASE INCREASED
2%
SINUSITIS
2%
DIARRHOEA
2%
NAUSEA
2%
HYPERTENSION
1%
NEPHROLITHIASIS
1%
HERPES ZOSTER
1%
ALANINE AMINOTRANSFERASE INCREASED
100%
80%
60%
40%
20%
0%
Study treatment Arm
Upadacitinib 15 mg: Week 1-24
Upadacitinib 30 mg: Week 1-56
Upadacitinib 30 mg: Week 1-24
Placebo: Week 1-24
Upadacitinib 15 mg: Week 1-56

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Upadacitinib (ABT-494) Dose BExperimental Treatment1 Intervention
Open label dose B QD
Group II: Upadacitinib (ABT-494) Dose AExperimental Treatment1 Intervention
Open label dose A once daily (QD)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABT-494
2017
Completed Phase 3
~1210

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,035 Previous Clinical Trials
522,937 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
456 Previous Clinical Trials
163,586 Total Patients Enrolled
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
101,514 Total Patients Enrolled

Media Library

Upadacitinib (ABT-494) (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02782663 — Phase 2
Crohn's Disease Research Study Groups: Upadacitinib (ABT-494) Dose A, Upadacitinib (ABT-494) Dose B
Crohn's Disease Clinical Trial 2023: Upadacitinib (ABT-494) Highlights & Side Effects. Trial Name: NCT02782663 — Phase 2
Upadacitinib (ABT-494) (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02782663 — Phase 2
~8 spots leftby Sep 2025
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