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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03345823
Ethics application status
Date submitted
15/11/2017
Date registered
17/11/2017
Date last updated
21/05/2020

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: Group A - Arm A - This is a maintenance group with 52 weeks which includes participants who achieved clinical response to upadacitinib dose A in studies M14-431 and M14-433 and will receive dose B.

Experimental: Group A - Arm B - This is a maintenance group with 52 weeks which includes participants who achieved clinical response to upadacitinib dose A in studies M14-431 and M14-433 and will receive dose C.

Experimental: Group A- Arm C - This is a maintenance group with 52 weeks which includes participants who achieved clinical response to upadacitinib dose A in studies M14-431 and M14-433 and will receive placebo.

Experimental: Group B - Arm A - This is a long-term extension group with 240 weeks which includes participants who complete group A and will receive dose B.

Experimental: Group B - Arm B - This is a long-term extension group with 240 weeks which includes participants who complete group A and will receive dose C.

Experimental: Group B - Arm C - This is a long-term extension group with 240 weeks which includes participants who complete group A.


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) - Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.
Timepoint [1] 0 0
Week 52
Primary outcome [2] 0 0
Sub-Study 1: Percentage of Participants with Endoscopic Response - Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline.
Timepoint [2] 0 0
Week 52
Primary outcome [3] 0 0
Sub-Study 2: Number of Participants with Adverse Events - An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 subject 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.
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) - Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100) - Decrease of at least 100 points in CDAI from Baseline.
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Sub-Study 1: Percentage of Participants who Discontinue Corticosteroid Use at Least 90 Days Prior to Week 52 and Achieve Clinical Remission, in Participants Taking Corticosteroids at Baseline. - 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.
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission - Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score. Endoscopic remission is defined per SES-CD.
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) - CDAI remission is defined as CDAI < 150.
Timepoint [5] 0 0
Through Week 52
Secondary outcome [6] 0 0
Sub-Study 1: Percentage of Participants with Endoscopic Remission - Endoscopic remission is defined per Simplified Endoscopic Score for Crohn's Disease (SES-CD).
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) - The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Timepoint [7] 0 0
Baseline (Week 0) to Week 52
Secondary outcome [8] 0 0
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) - The FACIT-F questionnaire was developed to assess fatigue.
Timepoint [8] 0 0
Baseline (Week 0) to Week 52
Secondary outcome [9] 0 0
Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD) - This is assessed by reviewing participant's hospitalization data.
Timepoint [9] 0 0
Week 52
Secondary outcome [10] 0 0
Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline - 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.
Timepoint [10] 0 0
Week 52

Eligibility
Key inclusion criteria
For Substudy 1:

- Participant who receive double-blind treatment in Study M14-431 or Study M14-433 and
achieve clinical response.

- 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 receive open-label upadacitinib Dose B in Study M14-431 and achieve
clinical response.

- Participant completes study procedures in the parent study/substudy.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For Sub-studies 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 of Study M14-430
that in the investigator's judgment makes the subject unsuitable for this study.

- Participant with any active or chronic recurring infections based on the
investigator's assessment that makes the subject an unsuitable candidate for the
study. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT
dosed until the infection treatment has been completed and the infection is cured,
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
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation & Gen Hos /ID# 171506 - Concord
Recruitment hospital [2] 0 0
Coral Sea Clinical Research /ID# 212989 - North Mackay
Recruitment hospital [3] 0 0
Mater Misericordiae /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 - Melbourne
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 - Melbourne
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
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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/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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03345823