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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04524611
Registration number
NCT04524611
Ethics application status
Date submitted
20/08/2020
Date registered
24/08/2020
Date last updated
18/06/2024
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)
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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
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Secondary ID [1]
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2020-002674-26
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Secondary ID [2]
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M20-259
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Universal Trial Number (UTN)
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Trial acronym
SEQUENCE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease (CD)
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
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0
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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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 (SC) risankizumab dose B every 8 weeks through Week 48. Participants who complete the Week 48 visit will continue SC risankizumab for up to an additional 220 weeks.
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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving Clinical Remission at Week 24
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Assessment method [1]
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Clinical remission is defined as Crohn's disease activity index (CDAI)\<150.
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Timepoint [1]
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Week 24
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Primary outcome [2]
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Percentage of Participants Achieving Endoscopic Remission
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Assessment method [2]
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Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \<= 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer.
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Timepoint [2]
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Week 48
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Primary outcome [3]
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Number of Participants Reporting Adverse Events
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Assessment method [3]
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. 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 participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
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Timepoint [3]
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Up to 220 Weeks
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Secondary outcome [1]
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Percentage of Participants Achieving Clinical Remission at Week 48
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Assessment method [1]
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Clinical remission is defined as Crohn's disease activity index (CDAI)\<150.
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Timepoint [1]
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Week 48
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Secondary outcome [2]
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Percentage of Participants Achieving Endoscopic Response at Week 48
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Assessment method [2]
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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).
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Timepoint [2]
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Week 48
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Secondary outcome [3]
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Percentage of Participants Achieving Endoscopic Response at Week 24
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Assessment method [3]
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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).
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Timepoint [3]
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Week 24
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Secondary outcome [4]
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Percentage of Participants Achieving Steroid-Free Endoscopic Remission
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Assessment method [4]
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Steroid-free endoscopic remission is defined as participants with endoscopic remission and not receiving steroids at Week 48.
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Timepoint [4]
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Week 48
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Secondary outcome [5]
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Percentage of Participants Achieving Steroid-Free Clinical Remission
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Assessment method [5]
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Steroid-free clinical remission is defined as participants with clinical remission and not receiving steroids at Week 48.
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Timepoint [5]
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Week 48
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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.
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Minimum age
18
Years
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/09/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
15/02/2028
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Actual
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Sample size
Target
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Accrual to date
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Final
527
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Wollongong Hospital /ID# 224688 - Wollongong
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Mater Misericordiae Limited /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 Medical Centre /ID# 224599 - Clayton
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2500 - Wollongong
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4101 - South Brisbane
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4222 - Southport
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5112 - Elizabeth Vale
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3168 - Clayton
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Haifa
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Country [119]
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Italy
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State/province [119]
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Genova
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Country [120]
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Italy
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State/province [120]
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Milano
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Country [121]
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Italy
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State/province [121]
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Roma
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Country [122]
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Italy
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State/province [122]
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Verona
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Country [123]
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Italy
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State/province [123]
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Bologna
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Country [124]
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Italy
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State/province [124]
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0
Cagliari
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Country [125]
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Italy
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State/province [125]
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Milan
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Country [126]
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Italy
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State/province [126]
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0
Palermo
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Country [127]
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Korea, Republic of
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State/province [127]
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Daejeon Gwang Yeogsi
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Country [128]
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Korea, Republic of
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State/province [128]
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Gyeongsangnamdo
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Country [129]
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Korea, Republic of
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State/province [129]
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Seoul Teugbyeolsi
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Country [130]
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Korea, Republic of
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State/province [130]
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Seoul
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Country [131]
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0
Mexico
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State/province [131]
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Baja California
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Country [132]
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Mexico
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State/province [132]
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Jalisco
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Country [133]
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Mexico
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State/province [133]
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0
Nuevo Leon
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Country [134]
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Mexico
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State/province [134]
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Yucatan
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Country [135]
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Mexico
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State/province [135]
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0
Veracruz
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Country [136]
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Netherlands
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State/province [136]
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Gelderland
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Country [137]
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Netherlands
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State/province [137]
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0
Noord-Holland
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Country [138]
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Netherlands
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State/province [138]
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Tilburg
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Country [139]
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Netherlands
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State/province [139]
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Utrecht
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Country [140]
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Poland
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State/province [140]
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Kujawsko-pomorskie
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Country [141]
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Poland
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State/province [141]
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Malopolskie
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Country [142]
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Poland
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State/province [142]
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Mazowieckie
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Country [143]
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Romania
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State/province [143]
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Bucuresti
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Country [144]
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Romania
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State/province [144]
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Bucharest
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Country [145]
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Romania
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Targu Mures
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Country [146]
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Romania
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State/province [146]
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Timi?oara
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Country [147]
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Russian Federation
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State/province [147]
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Kaliningradskaya Oblast
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Country [148]
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Russian Federation
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State/province [148]
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Moscow
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Country [149]
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Russian Federation
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State/province [149]
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St. Petersburg
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Country [150]
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Slovakia
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State/province [150]
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Nitriansky Kraj
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Country [151]
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Slovakia
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State/province [151]
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Presovsky Kraj
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Country [152]
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Slovakia
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State/province [152]
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Banska Bystrica
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Country [153]
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Slovakia
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State/province [153]
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Nove Zamky
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Country [154]
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South Africa
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State/province [154]
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Gauteng
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Country [155]
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South Africa
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State/province [155]
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Western Cape
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Country [156]
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Spain
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State/province [156]
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A Coruna
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Country [157]
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Spain
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State/province [157]
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Asturias
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Country [158]
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Spain
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State/province [158]
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Barcelona
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Country [159]
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Spain
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State/province [159]
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Madrid
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Country [160]
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Spain
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State/province [160]
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Alicante
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Country [161]
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Spain
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State/province [161]
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Sevilla
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Country [162]
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Spain
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State/province [162]
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Valencia
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Country [163]
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Sweden
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State/province [163]
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Stockholms Lan
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Country [164]
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Sweden
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State/province [164]
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Falun
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Country [165]
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Sweden
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State/province [165]
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Stockholm
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Country [166]
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Switzerland
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State/province [166]
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Basel-Stadt
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Country [167]
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Switzerland
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State/province [167]
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Zuerich
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Country [168]
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Switzerland
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State/province [168]
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Bern
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Country [169]
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Turkey
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State/province [169]
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Ankara
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Country [170]
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Turkey
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Istanbul
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Country [171]
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Turkey
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State/province [171]
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Mersin
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Country [172]
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Ukraine
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State/province [172]
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Kyiv
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Country [173]
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Ukraine
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Lviv
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Country [174]
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Ukraine
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State/province [174]
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Zaporizhzhia
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Country [175]
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United Kingdom
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State/province [175]
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Cambridgeshire
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Country [176]
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United Kingdom
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State/province [176]
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Devon
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Country [177]
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United Kingdom
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State/province [177]
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Hampshire
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Country [178]
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United Kingdom
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State/province [178]
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Hertfordshire
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Country [179]
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United Kingdom
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State/province [179]
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London, City Of
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Country [180]
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United Kingdom
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State/province [180]
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Nottinghamshire
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Country [181]
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United Kingdom
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Oxfordshire
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Country [182]
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United Kingdom
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State/province [182]
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Scotland
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Country [183]
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United Kingdom
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State/province [183]
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Belfast
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Country [184]
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United Kingdom
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State/province [184]
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Edinburgh
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Country [185]
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United Kingdom
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State/province [185]
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Huddersfield
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Country [186]
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United Kingdom
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State/province [186]
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London
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Country [187]
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United Kingdom
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Newcastle upon Tyne
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Country [188]
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United Kingdom
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State/province [188]
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Salford
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Country [189]
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United Kingdom
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Stirling
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Country [190]
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United Kingdom
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Tooting
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Ethics approval
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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.
In Part 1, 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. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks.
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.
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Trial website
https://clinicaltrials.gov/study/NCT04524611
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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AbbVie
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT04524611
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