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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 May 2023
• Main ID: NCT03345823
• Date of registration: 15/11/2017
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: 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
• Scientific 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
• Date of first enrolment: March 21, 2018
• Target sample size: 747
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03345823
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

American Samoa, Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: ABBVIE INC.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

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:

1. CDAI < 150

2. CRP < 5 mg/L and FCP < 250 mg/kg AND

3. 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Upadacitinib

Drug: Placebo for Upadacitinib

Primary Outcome(s)

Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) [Time Frame: Week 52]

Number of Participants with Adverse Events [Time Frame: Through Week 240]

Sub-Study 1: Percentage of Participants with Endoscopic Response [Time Frame: Week 52]

Secondary Outcome(s)

Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100) [Time Frame: Week 52]

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]

Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs) [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD) [Time Frame: Up to Week 52]

Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) [Time Frame: Baseline (Week 0) to Week 52]

Sub-Study 1: Percentage of Participants with Endoscopic Remission [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI [Time Frame: Through Week 52]

Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants without Corticosteroid use for Crohn's Disease Among All Participants [Time Frame: Week 52]

Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [Time Frame: Baseline (Week 0) to Week 52]

Secondary ID(s)

2017-001225-41

M14-430

Source(s) of Monetary Support

Please refer to primary and secondary sponsors