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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 96
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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%
INTESTINAL STENOSIS
2%
VOMITING
2%
ABDOMINAL ABSCESS
2%
GASTROINTESTINAL OBSTRUCTION
2%
CONSTIPATION
2%
ANAL ABSCESS
2%
PNEUMONIA ASPIRATION
2%
SEPSIS
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

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
954 Previous Clinical Trials
500,998 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,832 Total Patients Enrolled
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
101,450 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

Frequently Asked Questions

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

What are the potential risks associated with ABT-494?

"While Phase 2 trials don't yet have data supporting efficacy, ABT-494's safety was deemed to be supported by prior clinical studies and given a score of 2."

Answered by AI

Who meets the screening criteria for participation in this research project?

"This study is open to 210 individuals aged 18-75 that have ileocolitis. Additionally, potential participants must meet the following qualifications: If female, participant must be postmenopausal, surgically sterile or on using a birth control method., Participant must have completed Study M13-740 through Week 52."

Answered by AI

What are the conditions that ABT-494 is commonly used to address?

"ABT-494 is frequently used to treat patients that may require systemic therapy. Additionally, it can be given as treatment for rheumatoid arthritis, methotrexate, and other conditions where conventional therapies have been ineffective."

Answered by AI

Are there any available positions for participants in this research project?

"Although this specific trial is not looking for more participants at the moment, that doesn't mean there aren't other opportunities to get involved in medical research. According to clinicaltrials.gov, as of September 8th 2020, there are a total of 279 trials actively recruiting patients."

Answered by AI

At how many different hospitals is this clinical trial taking place?

"This trial currently has 42 patients, with locations such as Vancouver, Gainesville, and Cincinnati."

Answered by AI

What other research has been conducted using ABT-494?

"Currently, there are a total of 21 active studies investigating ABT-494. Of these, 14 are in Phase 3. Most trials for ABT-494 are based in Singapore and Central Singapore; however, there are 3924 locations worldwide conducting clinical trials for this medication."

Answered by AI

Will this study be enrolling any participants over the age of 55?

"The age range that is eligible for this study begins at 18 years old and ends at 75 years old."

Answered by AI

How many people are being enrolled in this trial?

"Recruitment for this trial closed on September 8th, 2022. The trial was posted on May 18th, 2016 and received its last update on the date of closure. For those looking for other opportunities, there are currently 258 ileocolitis studies and 21 ABT-494 trials actively recruiting patients."

Answered by AI

What is the difference between this clinical trial and others like it?

"Since 2015, ABT-494 has undergone extensive research with the first study being sponsored by AbbVie. In total, there have been 21 different trials conducted in 953 cities located across 54 countries."

Answered by AI
~15 spots leftby Sep 2025