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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04524611




Registration number
NCT04524611
Ethics application status
Date submitted
20/08/2020
Date registered
24/08/2020
Date last updated
27/04/2021

Titles & IDs
Public title
Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)
Scientific title
A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy
Secondary ID [1] 0 0
2020-002674-26
Secondary ID [2] 0 0
M20-259
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease (CD) 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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Risankizumab
Treatment: Drugs - Risankizumab
Treatment: Drugs - Ustekinumab
Treatment: Drugs - Ustekinumab

Experimental: Risankizumab Dose A Followed by Dose B - Participants will receive intravenous risankizumab dose A at Week 0, 4 ,8 followed by subcutaneous risankizumab dose B every 8 weeks through Week 48.

Experimental: Risankizumab Dose A Followed by Dose C - Participants will receive intravenous risankizumab dose A at Week 0, 4 ,8 followed by subcutaneous risankizumab dose C every 8 weeks through Week 48.

Active Comparator: Ustekinumab - Participants will receive weight-based intravenous ustekinumab at Week 0 followed by subcutaneous ustekinumab every 8 weeks through Week 48.


Treatment: Drugs: Risankizumab
Intravenous (IV) Infusion

Treatment: Drugs: Risankizumab
Subcutaneous (SC) Injection

Treatment: Drugs: Ustekinumab
Intravenous (IV) infusion

Treatment: Drugs: Ustekinumab
Subcutaneous (SC) injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Clinical Remission at Week 24 - Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
Timepoint [1] 0 0
Week 24
Primary outcome [2] 0 0
Percentage of Participants Achieving Clinical Remission at Week 48 - Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
Timepoint [2] 0 0
Week 48
Secondary outcome [1] 0 0
Percentage of Participants Achieving Endoscopic Response at Week 48 - Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Percentage of Participants Achieving Endoscopic Remission - Endoscopic remission is defined as decrease in SES-CD<=4 and at lease a 2-point reduction versus Baseline and no sub-score greater than 1 in any individual variable.
Timepoint [2] 0 0
Week 48
Secondary outcome [3] 0 0
Percentage of Participants Achieving Clinical Remission (Patient Reported Outcome [PRO]-2) - Clinical remission [PRO-2] is defined as average daily stool frequency (SF) <= 2.8 and not worse than Baseline AND average daily abdominal pain (AP) score <= 1 and not worse than Baseline.
Timepoint [3] 0 0
Week 48
Secondary outcome [4] 0 0
Percentage of Participants Achieving Endoscopic Response at Week 24 - Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Percentage of Participants Achieving Steroid-Free Remission - Steroid-free remission is defined as discontinuation of corticosteroid use for 90 days and achieving clinical remission at Week 48 in participants taking steroids at Baseline.
Timepoint [5] 0 0
Week 48

Eligibility
Key inclusion criteria
- Confirmed diagnosis of Crohn's disease (CD) for at least 3 months prior to Baseline.

- Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.

- Confirmed diagnosis of moderate to severe Crohn's Disease as assessed by stool
frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD
(SES-CD).

- Demonstrated intolerance or inadequate response to one or more anti-tumor necrosis
factor (TNF) therapies.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current diagnosis of ulcerative colitis or indeterminate colitis.

- Receipt of CD approved biologic agents prior to Baseline (as detailed in protocol), or
any investigational biologic or other agent or procedure prior to Baseline (as
detailed in protocol).

- Prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab).

- Currently know complications of CD (strictures, short bowel, etc).

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 assessing the outcomes
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
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NSW,QLD,SA,VIC
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Wollongong Hospital /ID# 224688 - Wollongong
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Mater Misericordiae /ID# 223642 - South Brisbane
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Griffith University /ID# 223641 - Southport
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Lyell McEwin Hospital /ID# 223643 - Elizabeth Vale
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Monash Health /ID# 224599 - Clayton
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
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4101 - South Brisbane
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4222 - Southport
Recruitment postcode(s) [4] 0 0
5112 - Elizabeth Vale
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3168 - Clayton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any
part of the gut. This study will evaluate how well risankizumab works compared to
ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI).

Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease
(CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD.
Participants are randomly assigned to one of the three treatment groups. Each group receives
a different treatment. There is a 1 in 2 chance that participants will be assigned to
ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in
approximately 307 sites worldwide.

Participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at
Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48.
Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at
Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48.

There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, blood tests,
checking for side effects and completing questionnaires.
Trial website
https://clinicaltrials.gov/show/NCT04524611
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
ABBVIE CALL CENTER
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Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04524611