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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 2017 Phase 2 trial • 220 Patients • NCT02365649
12%
CROHN'S DISEASE
8%
VIRAL UPPER RESPIRATORY TRACT INFECTION
8%
ARTHRALGIA
7%
ABDOMINAL PAIN
7%
URINARY TRACT INFECTION
7%
BLOOD CREATINE PHOSPHOKINASE INCREASED
5%
INFLUENZA LIKE ILLNESS
5%
OROPHARYNGEAL PAIN
5%
ABDOMINAL PAIN UPPER
5%
UPPER RESPIRATORY TRACT INFECTION
5%
C-REACTIVE PROTEIN INCREASED
5%
COUGH
3%
SMALL INTESTINAL OBSTRUCTION
3%
FATIGUE
2%
CONSTIPATION
2%
PNEUMONIA ASPIRATION
2%
INTESTINAL STENOSIS
2%
SEPSIS
2%
ANAL ABSCESS
2%
VOMITING
2%
GASTROINTESTINAL OBSTRUCTION
2%
ABDOMINAL ABSCESS
2%
INTERVERTEBRAL DISC PROTRUSION
2%
OSTEOARTHRITIS
2%
INFLUENZA
2%
INTESTINAL OBSTRUCTION
2%
CELLULITIS
2%
DEPRESSION
2%
NAUSEA
2%
PYREXIA
2%
SINUSITIS
2%
ACNE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Double-Blind Induction Phase: Placebo BID
Double Blind Extension Phase: 3 mg BID
Open Label Extension Subjects Received OL 24 mg BID
Double-Blind Induction Phase: Upadacitinib 3 mg BID
Double-Blind Induction Phase: Upadacitinib 6 mg BID
Double Blind Induction Phase: 12 mg BID
Double Blind Induction Phase: 24 mg BID
Double Blind Induction Phase: 24 mg QD
Double Blind Extension Phase: 6 mg BID
Double Blind Extension 12 mg BID
Open Label Extension Subjects Never Received OL 24 mg BID
Double Blind Extension 24 mg QD

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
2012
Completed Phase 2
~570

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,023 Previous Clinical Trials
520,182 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
444 Previous Clinical Trials
160,668 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
~9 spots leftby Sep 2025
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