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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03105128




Registration number
NCT03105128
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 Moderately to Severely Active Crohn's Disease
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease
Secondary ID [1] 0 0
2016-003123-32
Secondary ID [2] 0 0
M16-006
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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - placebo for risankizumab
Treatment: Drugs - risankizumab IV
Treatment: Drugs - risankizumab SC

Experimental: Risankizumab Dose 1 (Period 1) - Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.

Experimental: Risankizumab Dose 2 (Period 1) - Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.

Placebo comparator: Placebo (Period 1) - Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

Experimental: Risankizumab Dose 1 (Period 2) - Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.

Experimental: Risankizumab Dose 2 (Period 2) - Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.

Experimental: Risankizumab Dose 3 (Period 2) - Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.


Treatment: Drugs: placebo for risankizumab
Placebo for risankizumab administered by intravenous infusion

Treatment: Drugs: risankizumab IV
Risankizumab administered by intravenous infusion

Treatment: Drugs: risankizumab SC
Risankizumab administered by subcutaneous (SC) injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
US Specific: Percentage of Participants With Endoscopic Response
Timepoint [2] 0 0
Week 12
Primary outcome [3] 0 0
Global Outside of US: Percentage of Participants With Clinical Remission
Timepoint [3] 0 0
Week 12
Primary outcome [4] 0 0
Global Outside of US: Percentage of Participants With Endoscopic Response
Timepoint [4] 0 0
Week 12
Secondary outcome [1] 0 0
US Specific: Percentage of Participants With Clinical Remission
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Timepoint [2] 0 0
Week 4
Secondary outcome [3] 0 0
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Timepoint [5] 0 0
Week 4
Secondary outcome [6] 0 0
US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
US Specific: Percentage of Participants With Stool Frequency (SF) Remission
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
US Specific: Percentage of Participants With Abdominal Pain (AP) Remission
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
US Specific: Percentage of Participants With Endoscopic Remission
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
US Specific: Percentage of Participants With Enhanced Clinical Response
Timepoint [10] 0 0
Week 4
Secondary outcome [11] 0 0
US Specific: Percentage of Participants With Ulcer-Free Endoscopy
Timepoint [11] 0 0
Week 12
Secondary outcome [12] 0 0
US Specific: Percentage of Participants With Enhanced Clinical Response
Timepoint [12] 0 0
Week 12
Secondary outcome [13] 0 0
US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at
Timepoint [13] 0 0
Week 12
Secondary outcome [14] 0 0
US Specific: Percentage of Participants With CD-Related Hospitalization
Timepoint [14] 0 0
Week 12
Secondary outcome [15] 0 0
US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Timepoint [15] 0 0
Week 12
Secondary outcome [16] 0 0
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Timepoint [16] 0 0
Week 12
Secondary outcome [17] 0 0
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Timepoint [17] 0 0
Week 4
Secondary outcome [18] 0 0
Global Outside of US: Percentage of Participants With Clinical Remission
Timepoint [18] 0 0
Week 4
Secondary outcome [19] 0 0
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Timepoint [19] 0 0
Week 12
Secondary outcome [20] 0 0
Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Timepoint [20] 0 0
Week 12
Secondary outcome [21] 0 0
Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
Timepoint [21] 0 0
Week 12
Secondary outcome [22] 0 0
Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response
Timepoint [22] 0 0
Week 12
Secondary outcome [23] 0 0
Global Outside of US: Percentage of Participants With Endoscopic Remission
Timepoint [23] 0 0
Week 12
Secondary outcome [24] 0 0
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Timepoint [24] 0 0
Week 4
Secondary outcome [25] 0 0
Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy
Timepoint [25] 0 0
Week 12
Secondary outcome [26] 0 0
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Timepoint [26] 0 0
Week 12
Secondary outcome [27] 0 0
Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline
Timepoint [27] 0 0
Week 12
Secondary outcome [28] 0 0
Global Outside of US: Percentage of Participants With CD-Related Hospitalization
Timepoint [28] 0 0
Week 12
Secondary outcome [29] 0 0
Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Timepoint [29] 0 0
Week 12
Secondary outcome [30] 0 0
Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment
Timepoint [30] 0 0
Week 12
Secondary outcome [31] 0 0
Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score
Timepoint [31] 0 0
Week 12

Eligibility
Key inclusion criteria
* Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, participants 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
* Diagnosis of CD for at least 3 months prior to Baseline.
* Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
* Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD.
* If female, participant must meet the contraception recommendations.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
* Participants with unstable doses of concomitant Crohn's disease therapy.
* Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within 35 days or 5 half-lives prior to Baseline, whichever is longer.
* Prior exposure to p19 inhibitors (e.g., risankizumab).
* Complications of Crohn's disease.
* Having an ostomy or ileoanal pouch.
* Known active Coronavirus Disease 2019 (COVID-19) infection.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/04/2021
Sample size
Target
Accrual to date
Final
931
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Duplicate_Mater Hospital /ID# 167990 - South Brisbane
Recruitment hospital [2] 0 0
Griffith University /ID# 212627 - Southport
Recruitment hospital [3] 0 0
Lyell McEwin Hospital /ID# 211363 - Elizabeth Vale
Recruitment hospital [4] 0 0
Emeritus Research /ID# 213511 - Camberwell
Recruitment hospital [5] 0 0
Footscray Hospital /ID# 211361 - Footscray
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
4222 - Southport
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
3124 - Camberwell
Recruitment postcode(s) [5] 0 0
3011 - Footscray
Recruitment outside Australia
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United States of America
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Arkansas
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Salford

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing, please refer to the link below.
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 (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03105128