The trial is taking place at:
A

AZ Sint-Lucas | Center for Clinical Studies

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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

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AbbVie

Status and phase

Active, not recruiting
Phase 3

Conditions

Crohn's Disease

Treatments

Drug: Upadacitinib
Drug: Placebo for Upadacitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03345823
2017-001225-41 (EudraCT Number)
M14-430

Details and patient eligibility

About

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.

Enrollment

747 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 clincal response at the time descibed in the protocol and completes study procedures in the parent study/ substudy.

For Substudy 3:

Participant is an ongoing participant in Substudy 2 for at least 12 months.

Participant is in stable remission for at least 6 months defined as:

  • CDAI < 150
  • CRP < 5 mg/L and FCP < 250 mg/kg AND
  • Participant has not been on locally acting (rectal or suppository) or systemic corticosteroids for CD => 90 days prior to the entry of Substudy 3.

Exclusion criteria

For Substudies 1,2 and 3:

  • 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 or 2 of Study M14-430 (Week 52).

For Substudy 3 only:

  • Total SES-CD >4 and/or subscore >1 in any segment in the Substudy 2 annual ileo-colonoscopy, if performed within 6 months prior to Week 0 of Substudy 3.
  • Received any new medication or increase of the dose of current concomitant medication for the treatment of CD in the past 3 months.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

747 participants in 10 patient groups

Substudy 1: Cohort 1 Upadacitinib Dose A
Experimental group
Description:
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose A for 52 weeks.
Treatment:
Drug: Upadacitinib
Substudy 1: Cohort 1 Upadacitinib Dose B
Experimental group
Description:
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose B for 52 weeks.
Treatment:
Drug: Upadacitinib
Substudy 1: Cohort 1 Placebo
Experimental group
Description:
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive placebo for 52 weeks.
Treatment:
Drug: Placebo for Upadacitinib
Substudy 1: Cohort 2 Placebo
Experimental group
Description:
This is a maintenance group which includes participants who received double-blind placebo in studies M14-431 and M14-433 and achieved clinical response will continue to receive blinded placebo for 52 Weeks.
Treatment:
Drug: Placebo for Upadacitinib
Substudy 1: Cohort 3 Upadacitinib Dose B
Experimental group
Description:
This is a maintenance group which includes participants who achieved clinical response to upadacitinib from the extended treatment period of studies M14-431 and M14-433 and will receive upadacitinib Dose B for 52 Weeks.
Treatment:
Drug: Upadacitinib
Substudy 2: Cohort 4 Upadacitinib Dose B
Experimental group
Description:
This is a long-term extension group which includes participants who achieved clinical response in the open-label extended treatment period of study M14-431 and will receive upadacitinib dose B for 240 weeks.
Treatment:
Drug: Upadacitinib
Substudy 2: Cohort 5 Upadacitinib Dose A
Experimental group
Description:
This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose A for 240 weeks.
Treatment:
Drug: Upadacitinib
Substudy 2: Cohort 5 Upadacitinib Dose B
Experimental group
Description:
This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose B for 240 weeks.
Treatment:
Drug: Upadacitinib
Substudy 2: Cohort 5 Placebo
Experimental group
Description:
This is a long-term extension group which includes participants who complete Substudy 1 and will receive placebo for 240 weeks.
Treatment:
Drug: Placebo for Upadacitinib
Substudy 3: Cohort 6 Upadacitinib Dose A
Experimental group
Description:
This is the dose optimization group which includes participants from Substudy 2 who meet the criteria of stable remission will receive open-label upadacitinib dose A for up to 48 weeks.
Treatment:
Drug: Upadacitinib

Trial contacts and locations

467

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Data sourced from clinicaltrials.gov

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