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NCT Number: NCT03345823

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Crohn's Disease 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 3

Primary location

Cemic /Id# 169183, Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

For Substudy 1:

  • Participant who achieve clinical response in Study M14-431 or Study M14-433.
  • Participant completes study procedures in the parent study. The final endoscopy for Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.

For Substudy 2:

  • Participant completes Substudy 1. The Week 52 endoscopy may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.
  • Participant who achieved clinical response at the time described in the protocol and completes study procedures in the parent study/ substudy.

Exclusion criteria

For Substudies 1 and 2:

  • Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
  • Participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Studies M14-431 and M14-433 or Substudy 1 or 2 of Study M14-430 that in the investigator's judgment makes the participant unsuitable for this study.
  • Participant at the final visit of M14-431 or M14-433 with any active or chronic recurring infections based on the investigator's assessment that makes the participant an unsuitable candidate for the study. Participants with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is resolved, based on the investigator's assessment.
  • Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Studies M14-431, M14-433 or Substudy 1 of Study M14-430 (Week 52).

Treatment and study plan

Upadacitinib

Drug

Oral; Tablet

Other names: ABT-494, RINVOQ

Placebo for upadacitinib

Drug

Oral; Tablet

Primary outcomes

  1. Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)

    Time frame: Week 52

    Clinical remission per CDAI is defined as CDAI <150.

  2. Sub-Study 1: Percentage of Participants with Endoscopic Response

    Time frame: Week 52

    Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline.

  3. Number of Participants with Adverse Events

    Time frame: Through Week 240

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section.

Secondary outcomes

  1. Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs)

    Time frame: Week 52

    Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

  2. Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100)

    Time frame: Week 52

    Decrease of at least 100 points in CDAI from Baseline.

  3. Sub-Study 1: Percentage of Participants with Endoscopic Remission

    Time frame: Week 52

    Endoscopic remission is defined per Simplified Endoscopic Score for Crohn's Disease (SES-CD).

  4. Sub-Study 1: Percentage of Participants without Corticosteroid use for Crohn's Disease Among All Participants

    Time frame: Week 52

    This is assessed in participants not taking corticosteroids at least 90 days prior to Week 52 and achieved clinical remission per CDAI. Clinical remission is defined as CDAI <150.

  5. Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission

    Time frame: Week 52

    Clinical remission per CDAI is defined as CDAI <150. Endoscopic remission is defined per SES-CD.

  6. Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI

    Time frame: Through Week 52

    Clinical remission per CDAI is defined as CDAI <150 (as measured by the percentage of participants with clinical remission at Week 52 among those with clinical remission at Week 0).

  7. Sub-Study 1: Percentage of Participants who Discontinue Corticosteroid Use for Crohn's Disease at Least 90 Days Prior to Week 52 and Achieve Clinical Remission, in Participants Taking Corticosteroids at Baseline.

    Time frame: Week 52

    This is assessed in participants taking corticosteroids at Baseline. Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

  8. Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)

    Time frame: Baseline (Week 0) to Week 52

    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.

  9. Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

    Time frame: Baseline (Week 0) to Week 52

    The FACIT-F questionnaire was developed to assess fatigue.

  10. Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD)

    Time frame: Up to Week 52

    This is assessed by reviewing participant's hospitalization data.

  11. Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline

    Time frame: Week 52

    EIMs are defined as manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433

Acronym: U-ENDURE

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Nov 17, 2017
Registry last updated
Apr 9, 2026

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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