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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03105128
Ethics application status
Date submitted
4/04/2017
Date registered
7/04/2017
Date last updated
1/07/2020

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 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.

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

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 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 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.


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
Percentage of Participants With Clinical Remission - Clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score.
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
Percentage of Participants With Endoscopic Response - Endoscopic response defined as decrease from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD).
Timepoint [2] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission - The CDAI is used to evaluate disease activity in patients with Crohn's disease.
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response - The CDAI is used to evaluate disease activity in patients with Crohn's disease.
Timepoint [2] 0 0
Up to Week 12
Secondary outcome [3] 0 0
Percentage of Participants With Clinical Remission - Clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score.
Timepoint [3] 0 0
Week 4
Secondary outcome [4] 0 0
Mean Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue - The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities.
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Mean Change From Baseline of Induction in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score - Response in IBDQ Bowel Symptom domain is defined as increase of IBDQ bowel symptom domain score >=8 from Baseline
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Percentage of Participants With Enhanced Clinical Response and Endoscopic Response - Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score. Endoscopic response defined as decrease from Baseline in SES-CD.
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Percentage of Participants With Endoscopic Remission - Endoscopic remission is defined as decrease in SES-CD as compared to baseline
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Percentage of Participants With Enhanced Clinical Response - Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score.
Timepoint [8] 0 0
Up to Week 12
Secondary outcome [9] 0 0
Percentage of Participants With Ulcer-Free Endoscopy - Endoscopic healing was assessed using SES-CD.
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline - Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Percentage of Participants With CD-Related Hospitalization - Participants with an event that results in admission to the hospital.
Timepoint [11] 0 0
Up to Week 12
Secondary outcome [12] 0 0
Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline - Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Timepoint [12] 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, subjects 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, subject must meet the contraception recommendations
Minimum age
16 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject with a current diagnosis of ulcerative colitis or indeterminate colitis

- Subjects 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 (strictures, stenosis, short bowel, etc)

- Having an ostomy or ileoanal pouch

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Mater Hospital /ID# 167990 - 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 - 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
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Oxford

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of risankizumab versus
placebo during induction therapy in participants with moderately to severely active Crohn's
disease (CD).
Trial website
https://clinicaltrials.gov/show/NCT03105128
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
Address 0 0
Country 0 0
Phone 0 0
847.283.8955
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03105128