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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03105102
Registration number
NCT03105102
Ethics application status
Date submitted
4/04/2017
Date registered
7/04/2017
Titles & IDs
Public title
A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease
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Secondary ID [1]
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2016-003191-50
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Secondary ID [2]
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M16-000
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Universal Trial Number (UTN)
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Trial acronym
FORTIFY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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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
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0
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Crohn's disease
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo for Risankizumab SC
Treatment: Drugs - Risankizumab IV
Treatment: Drugs - Placebo for Risankizumab IV
Treatment: Drugs - Risankizumab SC
Treatment: Drugs - Risankizumab On-Body Injector (OBI)
Placebo comparator: Double-blind Placebo for Risankizumab (Sub-Study 1) - Participants randomized to receive double-blind placebo for risankizumab for 52 weeks.
Experimental: Double-blind Risankizumab Dose 1 (Sub-Study 1) - Participants randomized to receive double-blind risankizumab dose 1 for 52 weeks.
Experimental: Double-blind Risankizumab Dose 2 (Sub-Study 1) - Participants randomized to receive double-blind risankizumab dose 2 for 52 weeks.
Experimental: Maintenance Risankizumab Dose 1 (Sub-Study 2) - Participants will receive double-blind subcutaneous (SC)risankizumab dose 1 and intravenous placebo at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.
Experimental: Maintenance Risankizumab Dose 2 (Sub-Study 2) - Participants will receive double-blind subcutaneous placebo and intravenous risankizumab dose 3 at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.
Experimental: Open-label Risankizumab (Sub-Study 3) - Participants who completed Sub-study 1 or Sub-study 2 or other AbbVie risankizumab Crohn's disease study or M16-006 or M15-991 without endoscopy will receive open-label risankizumab dose 1 or dose 2 depending on their preceding study beginning at Week 56.
Experimental: Risankizumab On-Body Injector and Open Label (Sub-Study 4) - Participants in Sub-study 3 who meet eligible criteria for Sub-study 4 will receive risankizumab dose 1 or dose 2 via on-body injectors on Weeks 0,8 and 16. Beginning Week 24, participants will receive risankizumab dose 1 or dose 2 via pre-filled syringes Q8W.
Experimental: CTE: Open Label Continuous Treatment Extension - Participants who tolerate and derive benefit from receiving risankizumab and complete Sub-study 3 or Sub-study 4 will receive risankizumab dose 1 or dose 2 Q8W.
Treatment: Drugs: Placebo for Risankizumab SC
Placebo for Risankizumab SC Subcutaneous (SC) Injection
Treatment: Drugs: Risankizumab IV
Risankizumab IV Intravenous (IV) infusion
Treatment: Drugs: Placebo for Risankizumab IV
Placebo for Risankizumab IV Intravenous (IV) infusion
Treatment: Drugs: Risankizumab SC
Risankizumab SC Subcutaneous (SC) injection
Treatment: Drugs: Risankizumab On-Body Injector (OBI)
Subcutaneous (SC) injection; on-body injector (OBI)
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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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Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
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Assessment method [1]
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The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of \< 150.
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Timepoint [1]
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Week 52
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Primary outcome [2]
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Sub-Study 1: Percentage of Participants With Endoscopic Response
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Assessment method [2]
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Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).
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Timepoint [2]
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Week 52
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Primary outcome [3]
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Sub-Study 3: Number of Participants With 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 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. Treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
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Timepoint [3]
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Up to Week 220
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Primary outcome [4]
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Sub-Study 4: Percentage of Participants With an Observer Rating of Successful Participant Self Administration
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Assessment method [4]
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Participant who successfully completed the sequence of critical steps in the instructions for use (IFU) without errors to administer study drug via the OBI at Week 0 and 16.
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Timepoint [4]
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Up to Week 16
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Primary outcome [5]
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Sub-Study 4: Percentage of Participants who had no Potential Hazards
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Assessment method [5]
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Measured by an observer on the possible use-related hazards checklist for self-administration with OBI at Week 0 and Week 16.
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Timepoint [5]
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Up to Week 16
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Primary outcome [6]
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Sub-Study 4: Percentage of Participants Rating of Acceptability Using Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, 16
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Assessment method [6]
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SIAQ evaluations consist of the PRE module, which is self-completed immediately before the first OBI self-injection at baseline, and the POST module, which is self-completed 20 to 40 min following injections at Weeks 0, 8, 16. These modules are completed by participants while alone in a quiet environment.
Participants rate each item of the SIAQ. The ratings are later transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Domain scores are calculated only if at least half of the domain items are completed. Item and domain scores from the PRE module are compared with the corresponding item and domain scores from the POST modules.
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Timepoint [6]
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Up to Week 16
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Primary outcome [7]
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Sub-Study 4: Percentage of Participants in CDAI Clinical Remission at Week 0, 16
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Assessment method [7]
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Clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score.
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Timepoint [7]
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Up to Week 16
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Secondary outcome [1]
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Sub-Study 1: Percentage of Participants With Clinical Remission
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Assessment method [1]
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Clinical remission per average daily stool frequency (SF) and average daily AP score.
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Timepoint [1]
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Week 52
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Secondary outcome [2]
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Sub-Study 1: Percentage of Participants With CDAI Clinical Remission Among Participants With CDAI Clinical Remission in Week 0
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Assessment method [2]
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The CDAI is used to evaluate disease activity in patients with Crohn's disease
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Timepoint [2]
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Week 52
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Secondary outcome [3]
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Sub-Study 1: Percentage of Participants With Ulcer-Free Endoscopy
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Assessment method [3]
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Endoscopic healing was assessed using SES-CD.
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Timepoint [3]
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Week 52
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Secondary outcome [4]
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Sub-Study 1: Percentage of Participants With Endoscopic Remission
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Assessment method [4]
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Endoscopic Remission is defined as SES-CD \<= 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer
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Timepoint [4]
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Week 52
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Secondary outcome [5]
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Sub-Study 1: Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
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Assessment method [5]
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The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
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Timepoint [5]
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Week 52
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Secondary outcome [6]
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Sub-Study 1: Percentage of Participants Who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission in Participants Taking Steroids at Baseline
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Assessment method [6]
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Participants who discontinued corticosteroid use and achieved clinical remission per average daily SF and average daily AP score.
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Timepoint [6]
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Week 52
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Secondary outcome [7]
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Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
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Assessment method [7]
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The CDAI is used to evaluate disease activity in patients with Crohn's disease.
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Timepoint [7]
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Week 52
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Secondary outcome [8]
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Sub-Study 1: Percentage of Participants With Stool Frequency (SF) Remission
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Assessment method [8]
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SF Remission is defined by an average daily SF \<= 2.8 and not worse than baseline.
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Timepoint [8]
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Week 52
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Secondary outcome [9]
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Sub-Study 1: Percentage of Participants With Abdominal Pain (AP) Remission
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Assessment method [9]
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AP Remission is defined by an average daily AP \<= 1 and not worse than baseline.
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Timepoint [9]
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Week 52
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Secondary outcome [10]
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Sub-Study 1: Percentage of Participants With CDAI Clinical Remission and Endoscopic Response
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Assessment method [10]
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The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of \< 150. Endoscopic response defined as decrease from baseline of \> 50% of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).
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Timepoint [10]
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Week 52
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Secondary outcome [11]
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Sub-Study 1: Percentage of Participants With Deep Remission
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Assessment method [11]
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Deep remission defined as participants with both clinical remission (per average daily SF and average daily AP score) and endoscopic remission (assessed using SES-CD).
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Timepoint [11]
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Week 52
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Secondary outcome [12]
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Sub-Study 1: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52
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Assessment method [12]
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Participants with an event that results in admission to the hospital.
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Timepoint [12]
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Up to Week 52
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Eligibility
Key inclusion criteria
* Participants who have entered and completed Study M16-006 or Study M15-991 or other AbbVie risankizumab Crohn's disease study.
* Participants have completed the study M16-006 or M15-991 and have achieved clinical response.
* Sub-Study 4:
* Participants receiving maintenance treatment in Sub-study 3 and willing to comply with the requirements of Sub-study 4, including self-administration of sub-cutaneous injections using the on-body injector (OBI).
* Participant has received at least 16 weeks of stable dosing with risankizumab in Sub-study 3 (i.e., no rescue within 16 weeks and participant has surpassed the 72-week mark).
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Minimum age
16
Years
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Maximum age
80
Years
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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
* Participants should not be enrolled in Study M16-000 with high grade colonic dysplasia or colon cancer identified during Study M15-991, Study M16-006 or another AbbVie risankizumab Crohn's disease study if the final endoscopy was performed prior to enter Study M16-000 OR is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
* Participant who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of Chinese hamster ovary (CHO), OR had an adverse event (AE) during Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study that in the Investigator's judgment makes the participant unsuitable for this study.
* Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study.
* Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or another AbbVie risankizumab Crohn's disease study.
* Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
* Any active or chronic recurring infections based on the Investigator's assessment makes the participant an unsuitable candidate for the study.
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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 receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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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
9/04/2018
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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
14/05/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
1336
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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Mater Misericordiae Limited /ID# 167220 - South Brisbane
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Recruitment hospital [2]
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Griffith University /ID# 212635 - Southport
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Recruitment hospital [3]
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Lyell McEwin Hospital /ID# 212215 - Elizabeth Vale
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Recruitment hospital [4]
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Emeritus Research /ID# 213512 - Camberwell
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Recruitment postcode(s) [1]
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4101 - South Brisbane
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Recruitment postcode(s) [2]
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4222 - Southport
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Recruitment postcode(s) [3]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [4]
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3124 - Camberwell
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Recruitment outside Australia
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Chile
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Talcahuano
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China
Query!
State/province [74]
0
0
Sichuan
Query!
Country [75]
0
0
China
Query!
State/province [75]
0
0
Zhejiang
Query!
Country [76]
0
0
China
Query!
State/province [76]
0
0
Changsha
Query!
Country [77]
0
0
China
Query!
State/province [77]
0
0
Tianjin
Query!
Country [78]
0
0
Colombia
Query!
State/province [78]
0
0
Antioquia
Query!
Country [79]
0
0
Colombia
Query!
State/province [79]
0
0
Cundinamarca
Query!
Country [80]
0
0
Colombia
Query!
State/province [80]
0
0
Medellin
Query!
Country [81]
0
0
Colombia
Query!
State/province [81]
0
0
Medellín
Query!
Country [82]
0
0
Croatia
Query!
State/province [82]
0
0
Grad Zagreb
Query!
Country [83]
0
0
Croatia
Query!
State/province [83]
0
0
Splitsko-dalmatinska Zupanija
Query!
Country [84]
0
0
Croatia
Query!
State/province [84]
0
0
Osijek
Query!
Country [85]
0
0
Croatia
Query!
State/province [85]
0
0
Zadar
Query!
Country [86]
0
0
Czechia
Query!
State/province [86]
0
0
Praha 4
Query!
Country [87]
0
0
Czechia
Query!
State/province [87]
0
0
Praha 9
Query!
Country [88]
0
0
Czechia
Query!
State/province [88]
0
0
Hradec Kralove
Query!
Country [89]
0
0
Czechia
Query!
State/province [89]
0
0
Pardubice
Query!
Country [90]
0
0
Czechia
Query!
State/province [90]
0
0
Praha
Query!
Country [91]
0
0
Denmark
Query!
State/province [91]
0
0
Hovedstaden
Query!
Country [92]
0
0
Denmark
Query!
State/province [92]
0
0
Midtjylland
Query!
Country [93]
0
0
Denmark
Query!
State/province [93]
0
0
Sjælland
Query!
Country [94]
0
0
Denmark
Query!
State/province [94]
0
0
Syddanmark
Query!
Country [95]
0
0
Egypt
Query!
State/province [95]
0
0
Al Sharqia
Query!
Country [96]
0
0
Egypt
Query!
State/province [96]
0
0
Alexandria
Query!
Country [97]
0
0
Egypt
Query!
State/province [97]
0
0
Cairo
Query!
Country [98]
0
0
Estonia
Query!
State/province [98]
0
0
Harjumaa
Query!
Country [99]
0
0
Estonia
Query!
State/province [99]
0
0
Tallinn
Query!
Country [100]
0
0
France
Query!
State/province [100]
0
0
Alpes-Maritimes
Query!
Country [101]
0
0
France
Query!
State/province [101]
0
0
Gironde
Query!
Country [102]
0
0
France
Query!
State/province [102]
0
0
Herault
Query!
Country [103]
0
0
France
Query!
State/province [103]
0
0
Ile-de-France
Query!
Country [104]
0
0
France
Query!
State/province [104]
0
0
Isere
Query!
Country [105]
0
0
France
Query!
State/province [105]
0
0
Meurthe-et-Moselle
Query!
Country [106]
0
0
France
Query!
State/province [106]
0
0
Nord
Query!
Country [107]
0
0
France
Query!
State/province [107]
0
0
Rhone
Query!
Country [108]
0
0
France
Query!
State/province [108]
0
0
Somme
Query!
Country [109]
0
0
France
Query!
State/province [109]
0
0
Rennes
Query!
Country [110]
0
0
France
Query!
State/province [110]
0
0
St-Priest-en-Jarez
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Baden-Wuerttemberg
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Bayern
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Hessen
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Nordrhein-Westfalen
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
Saarland
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Sachsen
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Schleswig-Holstein
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Thueringen
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Berlin-Zehlendorf
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Berlin
Query!
Country [121]
0
0
Germany
Query!
State/province [121]
0
0
Braunschweig
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Dachau
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Hannover
Query!
Country [124]
0
0
Germany
Query!
State/province [124]
0
0
Lueneburg
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Magdeburg
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
Minden
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
Regensburg
Query!
Country [128]
0
0
Greece
Query!
State/province [128]
0
0
Attiki
Query!
Country [129]
0
0
Greece
Query!
State/province [129]
0
0
Kriti
Query!
Country [130]
0
0
Greece
Query!
State/province [130]
0
0
Athens
Query!
Country [131]
0
0
Greece
Query!
State/province [131]
0
0
Ioannina
Query!
Country [132]
0
0
Greece
Query!
State/province [132]
0
0
Nikaia
Query!
Country [133]
0
0
Greece
Query!
State/province [133]
0
0
Thessaloniki
Query!
Country [134]
0
0
Hong Kong
Query!
State/province [134]
0
0
Hong Kong
Query!
Country [135]
0
0
Ireland
Query!
State/province [135]
0
0
Dublin
Query!
Country [136]
0
0
Ireland
Query!
State/province [136]
0
0
Galway
Query!
Country [137]
0
0
Israel
Query!
State/province [137]
0
0
HaDarom
Query!
Country [138]
0
0
Israel
Query!
State/province [138]
0
0
Tel-Aviv
Query!
Country [139]
0
0
Israel
Query!
State/province [139]
0
0
Yerushalayim
Query!
Country [140]
0
0
Israel
Query!
State/province [140]
0
0
Haifa
Query!
Country [141]
0
0
Italy
Query!
State/province [141]
0
0
Ancona
Query!
Country [142]
0
0
Italy
Query!
State/province [142]
0
0
Calabria
Query!
Country [143]
0
0
Italy
Query!
State/province [143]
0
0
Genova
Query!
Country [144]
0
0
Italy
Query!
State/province [144]
0
0
Milano
Query!
Country [145]
0
0
Italy
Query!
State/province [145]
0
0
Roma
Query!
Country [146]
0
0
Italy
Query!
State/province [146]
0
0
Toscana
Query!
Country [147]
0
0
Italy
Query!
State/province [147]
0
0
Verona
Query!
Country [148]
0
0
Italy
Query!
State/province [148]
0
0
Bologna
Query!
Country [149]
0
0
Italy
Query!
State/province [149]
0
0
Catania
Query!
Country [150]
0
0
Italy
Query!
State/province [150]
0
0
Milan
Query!
Country [151]
0
0
Italy
Query!
State/province [151]
0
0
Modena
Query!
Country [152]
0
0
Italy
Query!
State/province [152]
0
0
Palermo
Query!
Country [153]
0
0
Italy
Query!
State/province [153]
0
0
Pavia
Query!
Country [154]
0
0
Japan
Query!
State/province [154]
0
0
Aichi
Query!
Country [155]
0
0
Japan
Query!
State/province [155]
0
0
Chiba
Query!
Country [156]
0
0
Japan
Query!
State/province [156]
0
0
Fukuoka
Query!
Country [157]
0
0
Japan
Query!
State/province [157]
0
0
Hiroshima
Query!
Country [158]
0
0
Japan
Query!
State/province [158]
0
0
Hokkaido
Query!
Country [159]
0
0
Japan
Query!
State/province [159]
0
0
Hyogo
Query!
Country [160]
0
0
Japan
Query!
State/province [160]
0
0
Ibaraki
Query!
Country [161]
0
0
Japan
Query!
State/province [161]
0
0
Ishikawa
Query!
Country [162]
0
0
Japan
Query!
State/province [162]
0
0
Kanagawa
Query!
Country [163]
0
0
Japan
Query!
State/province [163]
0
0
Mie
Query!
Country [164]
0
0
Japan
Query!
State/province [164]
0
0
Miyagi
Query!
Country [165]
0
0
Japan
Query!
State/province [165]
0
0
Osaka
Query!
Country [166]
0
0
Japan
Query!
State/province [166]
0
0
Saitama
Query!
Country [167]
0
0
Japan
Query!
State/province [167]
0
0
Shiga
Query!
Country [168]
0
0
Japan
Query!
State/province [168]
0
0
Shizuoka
Query!
Country [169]
0
0
Japan
Query!
State/province [169]
0
0
Tokyo
Query!
Country [170]
0
0
Japan
Query!
State/province [170]
0
0
Wakayama
Query!
Country [171]
0
0
Japan
Query!
State/province [171]
0
0
Yamagata
Query!
Country [172]
0
0
Japan
Query!
State/province [172]
0
0
Yamanashi
Query!
Country [173]
0
0
Japan
Query!
State/province [173]
0
0
Mitaka
Query!
Country [174]
0
0
Korea, Republic of
Query!
State/province [174]
0
0
Daejeon Gwang Yeogsi
Query!
Country [175]
0
0
Korea, Republic of
Query!
State/province [175]
0
0
Gyeonggido
Query!
Country [176]
0
0
Korea, Republic of
Query!
State/province [176]
0
0
Gyeongsangnamdo
Query!
Country [177]
0
0
Korea, Republic of
Query!
State/province [177]
0
0
Seoul Teugbyeolsi
Query!
Country [178]
0
0
Korea, Republic of
Query!
State/province [178]
0
0
Busan
Query!
Country [179]
0
0
Korea, Republic of
Query!
State/province [179]
0
0
Daegu
Query!
Country [180]
0
0
Korea, Republic of
Query!
State/province [180]
0
0
Seoul
Query!
Country [181]
0
0
Latvia
Query!
State/province [181]
0
0
Riga
Query!
Country [182]
0
0
Lithuania
Query!
State/province [182]
0
0
Kaunas
Query!
Country [183]
0
0
Lithuania
Query!
State/province [183]
0
0
Vilnius
Query!
Country [184]
0
0
Malaysia
Query!
State/province [184]
0
0
Sabah
Query!
Country [185]
0
0
Malaysia
Query!
State/province [185]
0
0
Selangor
Query!
Country [186]
0
0
Malaysia
Query!
State/province [186]
0
0
Kelantan
Query!
Country [187]
0
0
Mexico
Query!
State/province [187]
0
0
Jalisco
Query!
Country [188]
0
0
Mexico
Query!
State/province [188]
0
0
Morelos
Query!
Country [189]
0
0
Mexico
Query!
State/province [189]
0
0
Yucatan
Query!
Country [190]
0
0
Mexico
Query!
State/province [190]
0
0
Del. Benito Juárez
Query!
Country [191]
0
0
Netherlands
Query!
State/province [191]
0
0
Noord-Holland
Query!
Country [192]
0
0
Netherlands
Query!
State/province [192]
0
0
Tilburg
Query!
Country [193]
0
0
New Zealand
Query!
State/province [193]
0
0
Auckland
Query!
Country [194]
0
0
New Zealand
Query!
State/province [194]
0
0
Canterbury
Query!
Country [195]
0
0
New Zealand
Query!
State/province [195]
0
0
Otago
Query!
Country [196]
0
0
New Zealand
Query!
State/province [196]
0
0
Wellington
Query!
Country [197]
0
0
Norway
Query!
State/province [197]
0
0
Akershus
Query!
Country [198]
0
0
Norway
Query!
State/province [198]
0
0
Levanger
Query!
Country [199]
0
0
Norway
Query!
State/province [199]
0
0
Ålesund
Query!
Country [200]
0
0
Poland
Query!
State/province [200]
0
0
Dolnoslaskie
Query!
Country [201]
0
0
Poland
Query!
State/province [201]
0
0
Kujawsko-pomorskie
Query!
Country [202]
0
0
Poland
Query!
State/province [202]
0
0
Lodzkie
Query!
Country [203]
0
0
Poland
Query!
State/province [203]
0
0
Lubelskie
Query!
Country [204]
0
0
Poland
Query!
State/province [204]
0
0
Mazowieckie
Query!
Country [205]
0
0
Poland
Query!
State/province [205]
0
0
Podkarpackie
Query!
Country [206]
0
0
Poland
Query!
State/province [206]
0
0
Pomorskie
Query!
Country [207]
0
0
Poland
Query!
State/province [207]
0
0
Slaskie
Query!
Country [208]
0
0
Poland
Query!
State/province [208]
0
0
Warminsko-mazurskie
Query!
Country [209]
0
0
Poland
Query!
State/province [209]
0
0
Wielkopolskie
Query!
Country [210]
0
0
Poland
Query!
State/province [210]
0
0
Wroclaw
Query!
Country [211]
0
0
Portugal
Query!
State/province [211]
0
0
Braga
Query!
Country [212]
0
0
Portugal
Query!
State/province [212]
0
0
Faro
Query!
Country [213]
0
0
Portugal
Query!
State/province [213]
0
0
Porto
Query!
Country [214]
0
0
Portugal
Query!
State/province [214]
0
0
Setubal
Query!
Country [215]
0
0
Portugal
Query!
State/province [215]
0
0
Lisboa
Query!
Country [216]
0
0
Portugal
Query!
State/province [216]
0
0
Lisbon
Query!
Country [217]
0
0
Portugal
Query!
State/province [217]
0
0
Loures
Query!
Country [218]
0
0
Portugal
Query!
State/province [218]
0
0
Viseu
Query!
Country [219]
0
0
Romania
Query!
State/province [219]
0
0
Bucharest
Query!
Country [220]
0
0
Romania
Query!
State/province [220]
0
0
Cluj
Query!
Country [221]
0
0
Romania
Query!
State/province [221]
0
0
Timisoara
Query!
Country [222]
0
0
Romania
Query!
State/province [222]
0
0
Timi?oara
Query!
Country [223]
0
0
Russian Federation
Query!
State/province [223]
0
0
Kemerovskaya Oblast
Query!
Country [224]
0
0
Russian Federation
Query!
State/province [224]
0
0
Permskiy Kray
Query!
Country [225]
0
0
Russian Federation
Query!
State/province [225]
0
0
Sankt-Peterburg
Query!
Country [226]
0
0
Russian Federation
Query!
State/province [226]
0
0
Stavropol Skiy Kray
Query!
Country [227]
0
0
Russian Federation
Query!
State/province [227]
0
0
Tverskaya Oblast
Query!
Country [228]
0
0
Russian Federation
Query!
State/province [228]
0
0
Tyumenskaya Oblast
Query!
Country [229]
0
0
Russian Federation
Query!
State/province [229]
0
0
Udmurtskaya Respublika
Query!
Country [230]
0
0
Russian Federation
Query!
State/province [230]
0
0
Moscow
Query!
Country [231]
0
0
Russian Federation
Query!
State/province [231]
0
0
Novosibirsk
Query!
Country [232]
0
0
Russian Federation
Query!
State/province [232]
0
0
St. Petersburg
Query!
Country [233]
0
0
Russian Federation
Query!
State/province [233]
0
0
Ulyanovsk
Query!
Country [234]
0
0
Serbia
Query!
State/province [234]
0
0
Beograd
Query!
Country [235]
0
0
Serbia
Query!
State/province [235]
0
0
Sumadijski Okrug
Query!
Country [236]
0
0
Serbia
Query!
State/province [236]
0
0
Belgrade
Query!
Country [237]
0
0
Serbia
Query!
State/province [237]
0
0
Leskovac
Query!
Country [238]
0
0
Serbia
Query!
State/province [238]
0
0
Novi Sad
Query!
Country [239]
0
0
Singapore
Query!
State/province [239]
0
0
Singapore
Query!
Country [240]
0
0
Slovakia
Query!
State/province [240]
0
0
Nitriansky Kraj
Query!
Country [241]
0
0
Slovakia
Query!
State/province [241]
0
0
Presovsky Kraj
Query!
Country [242]
0
0
Slovakia
Query!
State/province [242]
0
0
Banska Bystrica
Query!
Country [243]
0
0
South Africa
Query!
State/province [243]
0
0
Gauteng
Query!
Country [244]
0
0
South Africa
Query!
State/province [244]
0
0
Western Cape
Query!
Country [245]
0
0
Spain
Query!
State/province [245]
0
0
A Coruna
Query!
Country [246]
0
0
Spain
Query!
State/province [246]
0
0
Barcelona
Query!
Country [247]
0
0
Spain
Query!
State/province [247]
0
0
Madrid
Query!
Country [248]
0
0
Spain
Query!
State/province [248]
0
0
Vizcaya
Query!
Country [249]
0
0
Spain
Query!
State/province [249]
0
0
Salamanca
Query!
Country [250]
0
0
Spain
Query!
State/province [250]
0
0
Sevilla
Query!
Country [251]
0
0
Spain
Query!
State/province [251]
0
0
Valencia
Query!
Country [252]
0
0
Spain
Query!
State/province [252]
0
0
Zaragoza
Query!
Country [253]
0
0
Sweden
Query!
State/province [253]
0
0
Skane Lan
Query!
Country [254]
0
0
Sweden
Query!
State/province [254]
0
0
Stockholms Lan
Query!
Country [255]
0
0
Sweden
Query!
State/province [255]
0
0
Vastra Gotalands Lan
Query!
Country [256]
0
0
Sweden
Query!
State/province [256]
0
0
Stockholm
Query!
Country [257]
0
0
Switzerland
Query!
State/province [257]
0
0
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Funding & Sponsors
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Commercial sector/industry
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Name
AbbVie
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Summary
Brief summary
The study consists of 4 sub-studies, as follows: * Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991; * Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991; * Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab; * Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab. * OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.
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Trial website
https://clinicaltrials.gov/study/NCT03105102
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Trial related presentations / publications
Ferrante M, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M, Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Panes J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y, Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K, D'Haens G. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022 May 28;399(10340):2031-2046. doi: 10.1016/S0140-6736(22)00466-4.
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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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/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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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/NCT03105102