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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03104413




Registration number
NCT03104413
Ethics application status
Date submitted
4/04/2017
Date registered
7/04/2017
Date last updated
14/06/2022

Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Secondary ID [1] 0 0
2016-003190-17
Secondary ID [2] 0 0
M15-991
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 IV
Treatment: Drugs - risankizumab SC
Treatment: Drugs - risankizumab IV

Experimental: Risankizumab Dose 1 (Induction Period 1) - Participants randomized to receive risankizumab dose 1 in Induction Period 1.

Experimental: Risankizumab Dose 2 (Induction Period 1) - Participants randomized to receive risankizumab dose 2 in Induction Period 1.

Placebo Comparator: Placebo (Induction Period 1) - Participants randomized to receive placebo for risankizumab in Induction Period 1.

Experimental: Risankizumab Dose 1 (Induction 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 (Induction 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 (Induction 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 IV
placebo for risankizumab administered as intravenous (IV) infusion.

Treatment: Drugs: risankizumab SC
risankizumab administered by subcutaneous (SC) injection

Treatment: Drugs: risankizumab IV
risankizumab administered as intravenous (IV) infusion.
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 Baseline Baseline
Timepoint [13] 0 0
Week 12
Secondary outcome [14] 0 0
US Specific: Percentage of Participants With CD-Related Hospitalization
Timepoint [14] 0 0
Up to 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 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.

- Confirmed diagnosis of 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 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 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 minimally 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
18/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/05/2021
Sample size
Target
Accrual to date
Final
618
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Mater Misericordiae Limited /ID# 167216 - South Brisbane
Recruitment hospital [2] 0 0
Griffith University /ID# 212631 - Southport
Recruitment hospital [3] 0 0
Lyell McEwin Hospital /ID# 211364 - Elizabeth Vale
Recruitment hospital [4] 0 0
Emeritus Research /ID# 213510 - Camberwell
Recruitment hospital [5] 0 0
Footscray Hospital /ID# 211362 - 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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???????
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus
placebo during induction therapy in participants with moderately to severely active CD.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03104413
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03104413