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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 96

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

VIRAL UPPER RESPIRATORY TRACT INFECTION

ARTHRALGIA

ABDOMINAL PAIN

URINARY TRACT INFECTION

BLOOD CREATINE PHOSPHOKINASE INCREASED

INFLUENZA LIKE ILLNESS

OROPHARYNGEAL PAIN

ABDOMINAL PAIN UPPER

UPPER RESPIRATORY TRACT INFECTION

C-REACTIVE PROTEIN INCREASED

COUGH

SMALL INTESTINAL OBSTRUCTION

FATIGUE

GASTROINTESTINAL OBSTRUCTION

ABDOMINAL ABSCESS

VOMITING

INTESTINAL STENOSIS

PNEUMONIA ASPIRATION

ANAL ABSCESS

CONSTIPATION

SEPSIS

INTERVERTEBRAL DISC PROTRUSION

OSTEOARTHRITIS

INFLUENZA

INTESTINAL OBSTRUCTION

CELLULITIS

DEPRESSION

NAUSEA

PYREXIA

SINUSITIS

ACNE

100%

80%

60%

40%

20%

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

962 Previous Clinical Trials

503,064 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

400 Previous Clinical Trials

147,638 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

Recent research and studies

Clinical Gastroenterology and HepatologyJournal

Upadacitinib Was Efficacious and Well-tolerated over 30 Months in Patients with Crohn’s Disease in the CELEST Extension Study

D’Haens, Geert, Julian Panés, Edouard Louis, Ana Lacerda, Qian Zhou, John Liu, and Edward V. Loftus Jr.. 2022. “Upadacitinib Was Efficacious and Well-tolerated over 30 Months in Patients with Crohn’s Disease in the CELEST Extension Study”. Clinical Gastroenterology and Hepatology. Elsevier BV. doi:10.1016/j.cgh.2021.12.030.

Clinical Gastroenterology and HepatologyJournal

Upadacitinib Was Efficacious and Well-tolerated over 30 Months in Patients with Crohn’s Disease in the CELEST Extension Study

clinicaltrials.govStudy

A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease

2016. "A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02782663.

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