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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03345823
Ethics application status
Date submitted
15/11/2017
Date registered
17/11/2017

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
2023-504951-29
Secondary ID [2] 0 0
M14-430
Universal Trial Number (UTN)
Trial acronym
U-ENDURE
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.


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 clinical response at the time described in the protocol and completes study procedures in the parent study/ substudy.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

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
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5000 - Adelaide
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3128 - Box Hill
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
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Country [191] 0 0
Netherlands
State/province [191] 0 0
Gelderland
Country [192] 0 0
Netherlands
State/province [192] 0 0
Limburg
Country [193] 0 0
Netherlands
State/province [193] 0 0
Amsterdam
Country [194] 0 0
Netherlands
State/province [194] 0 0
Enschede
Country [195] 0 0
Poland
State/province [195] 0 0
Dolnoslaskie
Country [196] 0 0
Poland
State/province [196] 0 0
Malopolskie
Country [197] 0 0
Poland
State/province [197] 0 0
Mazowieckie
Country [198] 0 0
Portugal
State/province [198] 0 0
Braga
Country [199] 0 0
Portugal
State/province [199] 0 0
Porto
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Portugal
State/province [200] 0 0
Setubal
Country [201] 0 0
Portugal
State/province [201] 0 0
Viana Do Castelo
Country [202] 0 0
Puerto Rico
State/province [202] 0 0
San Juan
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Romania
State/province [203] 0 0
Bucuresti
Country [204] 0 0
Romania
State/province [204] 0 0
Cluj
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Romania
State/province [205] 0 0
Timi?oara
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State/province [206] 0 0
Kaliningradskaya Oblast
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Russian Federation
State/province [207] 0 0
Novosibirskaya Oblast
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Russian Federation
State/province [208] 0 0
Permskiy Kray
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Russian Federation
State/province [209] 0 0
Stavropol Skiy Kray
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Russian Federation
State/province [210] 0 0
Tatarstan, Respublika
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Russian Federation
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Moscow
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Russian Federation
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Murmansk
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Russian Federation
State/province [213] 0 0
Petrozavodsk
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Russian Federation
State/province [214] 0 0
Pushkin
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Russian Federation
State/province [215] 0 0
Saint Petersburg
Country [216] 0 0
Russian Federation
State/province [216] 0 0
St. Petersburg
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Serbia
State/province [217] 0 0
Beograd
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Serbia
State/province [218] 0 0
Sumadijski Okrug
Country [219] 0 0
Serbia
State/province [219] 0 0
Vojvodina
Country [220] 0 0
Singapore
State/province [220] 0 0
Singapore
Country [221] 0 0
Slovakia
State/province [221] 0 0
Nitriansky Kraj
Country [222] 0 0
Slovakia
State/province [222] 0 0
Banska Bystrica
Country [223] 0 0
Slovenia
State/province [223] 0 0
Ljubljana
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South Africa
State/province [224] 0 0
Free State
Country [225] 0 0
South Africa
State/province [225] 0 0
Gauteng
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South Africa
State/province [226] 0 0
Western Cape
Country [227] 0 0
Spain
State/province [227] 0 0
Cantabria
Country [228] 0 0
Spain
State/province [228] 0 0
Illes Balears
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Spain
State/province [229] 0 0
Las Palmas
Country [230] 0 0
Spain
State/province [230] 0 0
Navarra
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Spain
State/province [231] 0 0
A Coruna
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Spain
State/province [232] 0 0
Barcelona
Country [233] 0 0
Spain
State/province [233] 0 0
Girona
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Spain
State/province [234] 0 0
Huelva
Country [235] 0 0
Spain
State/province [235] 0 0
Madrid
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Spain
State/province [236] 0 0
Salamanca
Country [237] 0 0
Spain
State/province [237] 0 0
Sevilla
Country [238] 0 0
Spain
State/province [238] 0 0
Valencia
Country [239] 0 0
Sweden
State/province [239] 0 0
Hallands Lan
Country [240] 0 0
Sweden
State/province [240] 0 0
Stockholms Lan
Country [241] 0 0
Sweden
State/province [241] 0 0
Vastra Gotalands Lan
Country [242] 0 0
Switzerland
State/province [242] 0 0
Zuerich
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Switzerland
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Bern
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Taiwan
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Taipei
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Taiwan
State/province [245] 0 0
Taichung
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Taiwan
State/province [246] 0 0
Taoyuan City
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Turkey
State/province [247] 0 0
Ankara
Country [248] 0 0
Turkey
State/province [248] 0 0
Istanbul
Country [249] 0 0
Turkey
State/province [249] 0 0
Kayseri
Country [250] 0 0
Turkey
State/province [250] 0 0
Battalgazi/malatya
Country [251] 0 0
Turkey
State/province [251] 0 0
Hatay
Country [252] 0 0
Turkey
State/province [252] 0 0
Mersin
Country [253] 0 0
Ukraine
State/province [253] 0 0
Vinnytska Oblast
Country [254] 0 0
Ukraine
State/province [254] 0 0
Kharkiv
Country [255] 0 0
Ukraine
State/province [255] 0 0
Kyiv
Country [256] 0 0
Ukraine
State/province [256] 0 0
Lviv
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United Kingdom
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Cheshire West And Chester
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United Kingdom
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London, City Of
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United Kingdom
State/province [259] 0 0
Warrington
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United Kingdom
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Bath
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United Kingdom
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Belfast
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United Kingdom
State/province [262] 0 0
Birmingham
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United Kingdom
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Dudley
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United Kingdom
State/province [264] 0 0
Harrow
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United Kingdom
State/province [265] 0 0
London
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
State/province [267] 0 0
Stockport
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United Kingdom
State/province [268] 0 0
Taunton
Country [269] 0 0
United Kingdom
State/province [269] 0 0
Tooting
Country [270] 0 0
United Kingdom
State/province [270] 0 0
Wolverhampton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ ourmember/abbvie/
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03345823