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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

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
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
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Arizona
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California
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Connecticut
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Minnesota
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New Jersey
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Tennessee
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Texas
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West Virginia
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Wisconsin
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Canada
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Alberta
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Canada
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Ontario
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China
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Chongqing
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China
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Guangdong
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China
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Guizhou
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China
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Jiangsu
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China
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Jiangxi
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China
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Zhejiang
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China
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Luo Yang
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Israel
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Tel-Aviv
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Israel
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Yerushalayim
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Israel
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Haifa
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Hyogo
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Japan
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Shizuoka
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Korea, Republic of
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Daejeon Gwang Yeogsi
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Serbia
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Beograd
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Serbia
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Pomoravski Okrug
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Serbia
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Novi Sad
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Taiwan
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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
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Bolton
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United Kingdom
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Birmingham
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United Kingdom
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Prescot
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United Kingdom
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Tooting

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
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
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 clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

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 visit https://vivli.org/ourmember/abbvie/
Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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?

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/NCT06063967