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Completed

NCT Number: NCT02782663

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

This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).

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Key information

Conditions

Crohn's Disease (CD) Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duplicate_CHU de Liege /ID# 149912, Liège, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant must have completed Study M13-740 through Week 52.
  • If female, participant must be postmenopausal, surgically sterile or on using a birth control method.

Exclusion criteria

  • For any reason participant is considered by the investigator to be an unsuitable candidate
  • Female participant with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study.
  • Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.

Treatment and study plan

ABT-494

Drug

Tablet: Oral

Other names: Upadacitinib, RINVOQ

Primary outcomes

  1. Percentage of Participants Achieving Remission

    Time frame: Up to Month 96

    It is defined as the percentage of participants achieving clinical remission and endoscopic remission.

  2. Percentage of Participants in Remission at Week 0 Who Maintain Remission

    Time frame: Up to Month 96

    Remission is defined as participants achieving clinical remission and endoscopic remission.

  3. Percentage of Participants Achieving Response

    Time frame: Up to Month 96

    It is defined as the percentage of participants achieving clinical response and endoscopic response.

  4. Percentage of Participants Achieving Clinical Remission

    Time frame: Up to Month 96

    Clinical remission is defined based on the patient reported outcomes: average daily stool frequency and average daily abdominal pain.

  5. Percentage of Participants Achieving Modified Clinical Remission

    Time frame: Up to Month 96

    Clinical remission is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.

  6. Percentage of Participants Achieving Enhanced Clinical Response

    Time frame: Up to Month 96

    Enhanced clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.

  7. Percentage of Participants Achieving Clinical Response

    Time frame: Up to Month 96

    Clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.

  8. Percentage of Participants Achieving Endoscopic Remission

    Time frame: Up to Month 96

    Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.

  9. Percentage of Participants in Endoscopic Remission at Week 0 Who Maintain Endoscopic Remission

    Time frame: Up to Month 96

    Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.

  10. Percentage of Participants Achieving Endoscopic Improvement

    Time frame: Up to Month 96

    Endoscopic improvement is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease or endoscopic remission.

  11. Percentage of Participants Achieving Endoscopic Response

    Time frame: Up to Month 96

    Endoscopic response is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease.

  12. Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Remission

    Time frame: Up to Month 96

    It is defined as CDAI less than 150.

  13. Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Response

    Time frame: Up to Month 96

    CDAI response is defined as a reduction in CDAI by >= 70 from baseline of Study M13-740.

  14. Percentage of Participants Achieving Enhanced CDAI Response

    Time frame: Up to Month 96

    Enhanced CDAI response is defined as reduction in CDAI by >= 100 from baseline of Study M13-740.

  15. Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission

    Time frame: Up to Month 96

    IBDQ remission is defined as IBDQ >= 170.

  16. Percentage of Participants Achieving IBDQ Response

    Time frame: Up to Month 96

    IBDQ response is defined as an increase in IBDQ score >= 16 point from Baseline of Study M13-740.

  17. Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free

    Time frame: Up to Month 96

    Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free

  18. Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free for At Least 90 Days and Achieve Remission

    Time frame: Up to Month 96

    Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free for at least 90 days over time and achieve Remission

  19. Percentage of Participants Achieving Remission and Normal C-Reactive Protein

    Time frame: Up to Month 96

    Percentage of participants achieving Remission and normal C-reactive protein. Remission is defined as Clinical Remission AND Endoscopic Remission.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
May 25, 2016
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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