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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06063967




Registration number
NCT06063967
Ethics application status
Date submitted
26/09/2023
Date registered
3/10/2023
Date last updated
5/11/2024

Titles & IDs
Public title
A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.
Scientific title
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects With Moderately to Severely Active Crohn's Disease
Secondary ID [1] 0 0
2024-516023-13-00
Secondary ID [2] 0 0
M23-784
Universal Trial Number (UTN)
Trial acronym
Risa CD SubQ
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
Description of intervention(s) / exposure
Treatment: Drugs - Risankizumab SC
Treatment: Drugs - Placebo for risankizumab

Experimental: Period A: Risankizumab Dose A - Participants randomized to receive risankizumab Dose A administered by subcutaneous (SC) injection for up to 12 weeks during Period A.

Placebo comparator: Period A: Placebo - Participants randomized to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks during Period A.

Experimental: Period B: Risankizumab Dose B - Participants randomized to receive risankizumab Dose A in Period A that achieved adequate response to receive risankizumab Dose B administered by subcutaneous (SC) injection for up to 12 weeks.

Placebo comparator: Period B: Placebo - Participants randomized to receive placebo risankizumab in Period A that achieved adequate response to continue to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks in Period B.

Experimental: Period B: Risankizumab Dose C - Participants with inadequate response in Period A to receive Dose C administered by Subcutaneous (SC) injection for up to 12 weeks during Period B.

Experimental: Period C: Open-Label Risankizumab Dose D - Participants who complete the Period B Week 24 visit to receive open-label risankizumab Dose D administered by subcutaneous (SC) injection for up to 52 weeks during Period C.


Treatment: Drugs: Risankizumab SC
subcutaneous (SC) injection

Treatment: Drugs: Placebo for risankizumab
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 Crohn's Disease Activity Index (CDAI) Clinical Remission (CDAI < 150)
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
Percentage of Participants With Endoscopic Response
Timepoint [2] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants With Clinical Remission
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants With Endoscopic Remission
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage of Participants With Ulcer-Free Endoscopy
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants with a CR-100 Clinical Response
Timepoint [5] 0 0
Week 4

Eligibility
Key inclusion criteria
* Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline.
* Participant meets the following disease activity criteria:

1. Moderate to severe CD as assessed by CDAI
2. Endoscopic evidence of mucosal inflammation as documented by a SES-CD
* Participant has demonstrated intolerance, loss of response or inadequate response to conventional or advanced therapies for CD.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with a current diagnosis of ulcerative colitis or indeterminate colitis.
* Participants with unstable doses of concomitant Crohn's disease therapy.
* Participants with prior exposure to p19 inhibitors.
* Participants with complications of Crohn's disease.
* Participants 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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
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
15/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/02/2029
Actual
Sample size
Target
276
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Connecticut
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United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
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United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
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United States of America
State/province [8] 0 0
Indiana
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United States of America
State/province [9] 0 0
Kansas
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United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
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United States of America
State/province [12] 0 0
Massachusetts
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United States of America
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Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
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United States of America
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North Dakota
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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West Virginia
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United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Canada
State/province [25] 0 0
Alberta
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
China
State/province [27] 0 0
Chongqing
Country [28] 0 0
China
State/province [28] 0 0
Guangdong
Country [29] 0 0
China
State/province [29] 0 0
Guizhou
Country [30] 0 0
China
State/province [30] 0 0
Jiangsu
Country [31] 0 0
China
State/province [31] 0 0
Jiangxi
Country [32] 0 0
China
State/province [32] 0 0
Zhejiang
Country [33] 0 0
China
State/province [33] 0 0
Luo Yang
Country [34] 0 0
Israel
State/province [34] 0 0
Tel-Aviv
Country [35] 0 0
Israel
State/province [35] 0 0
Yerushalayim
Country [36] 0 0
Israel
State/province [36] 0 0
Haifa
Country [37] 0 0
Japan
State/province [37] 0 0
Aichi
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Japan
State/province [38] 0 0
Chiba
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Japan
State/province [39] 0 0
Hyogo
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Japan
State/province [40] 0 0
Shizuoka
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Korea, Republic of
State/province [41] 0 0
Daejeon Gwang Yeogsi
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Korea, Republic of
State/province [42] 0 0
Seoul Teugbyeolsi
Country [43] 0 0
Korea, Republic of
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Daegu
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Korea, Republic of
State/province [44] 0 0
Seoul
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Serbia
State/province [45] 0 0
Beograd
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Serbia
State/province [46] 0 0
Pomoravski Okrug
Country [47] 0 0
Serbia
State/province [47] 0 0
Novi Sad
Country [48] 0 0
Taiwan
State/province [48] 0 0
Taipei
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Taiwan
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New Taipei City
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Taiwan
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Taichung
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Taiwan
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Taoyuan City
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Mersin
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United Kingdom
State/province [55] 0 0
Bolton
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United Kingdom
State/province [56] 0 0
Birmingham
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Prescot
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Tooting

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

Ethics approval
Ethics application status

Summary
Brief summary
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants.

Risankizumab is an approved drug for adults with CD. This study comprises of a Period A, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. In Period C, eligible participants will receive open-label risankizumab SC Dose D. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally.

Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.
Trial website
https://clinicaltrials.gov/study/NCT06063967
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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
844-663-3742
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06063967