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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03345823




Registration number
NCT03345823
Ethics application status
Date submitted
15/11/2017
Date registered
17/11/2017
Date last updated
18/05/2023

Titles & IDs
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
Secondary ID [1] 0 0
2017-001225-41
Secondary ID [2] 0 0
M14-430
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Placebo for Upadacitinib

Experimental: Substudy 1: Cohort 1 Upadacitinib Dose A - 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.

Experimental: Substudy 1: Cohort 1 Upadacitinib Dose B - 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.

Experimental: Substudy 1: Cohort 1 Placebo - 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.

Experimental: Substudy 1: Cohort 2 Placebo - 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.

Experimental: Substudy 1: Cohort 3 Upadacitinib Dose B - 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.

Experimental: Substudy 2: Cohort 4 Upadacitinib Dose B - 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.

Experimental: Substudy 2: Cohort 5 Upadacitinib Dose A - This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose A for 240 weeks.

Experimental: Substudy 2: Cohort 5 Upadacitinib Dose B - This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose B for 240 weeks.

Experimental: Substudy 2: Cohort 5 Placebo - This is a long-term extension group which includes participants who complete Substudy 1 and will receive placebo for 240 weeks.

Experimental: Substudy 3: Cohort 6 Upadacitinib Dose A - 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: Drugs: Upadacitinib
Oral; Tablet

Treatment: Drugs: Placebo for Upadacitinib
Oral; Tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)
Timepoint [1] 0 0
Week 52
Primary outcome [2] 0 0
Sub-Study 1: Percentage of Participants with Endoscopic Response
Timepoint [2] 0 0
Week 52
Primary outcome [3] 0 0
Number of Participants with Adverse Events
Timepoint [3] 0 0
Through Week 240
Secondary outcome [1] 0 0
Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs)
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100)
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Sub-Study 1: Percentage of Participants with Endoscopic Remission
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Sub-Study 1: Percentage of Participants without Corticosteroid use for Crohn's Disease Among All Participants
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI
Timepoint [6] 0 0
Through Week 52
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Week 52
Secondary outcome [8] 0 0
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
Timepoint [8] 0 0
Baseline (Week 0) to Week 52
Secondary outcome [9] 0 0
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Timepoint [9] 0 0
Baseline (Week 0) to Week 52
Secondary outcome [10] 0 0
Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD)
Timepoint [10] 0 0
Up to Week 52
Secondary outcome [11] 0 0
Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline
Timepoint [11] 0 0
Week 52

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/09/2027
Actual
Sample size
Target
747
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital /ID# 171506 - Concord
Recruitment hospital [2] 0 0
Coral Sea Clinical Research institute /ID# 212989 - North Mackay
Recruitment hospital [3] 0 0
Mater Misericordiae Limited /ID# 204910 - South Brisbane
Recruitment hospital [4] 0 0
Royal Adelaide Hospital /ID# 171508 - Adelaide
Recruitment hospital [5] 0 0
Box Hill Hospital /ID# 203735 - Box Hill
Recruitment hospital [6] 0 0
Fiona Stanley Hospital /ID# 171507 - Murdoch
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4740 - North Mackay
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
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United States of America
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Alabama
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Israel
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Rehovot
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Bologna
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Catania
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Kanagawa
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Kyoto
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Mie
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Osaka
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Saitama
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Shiga
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Shizuoka
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Tokyo
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Toyama
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Wakayama
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Korea, Republic of
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03345823
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries