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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05995353




Registration number
NCT05995353
Ethics application status
Date submitted
10/08/2023
Date registered
16/08/2023

Titles & IDs
Public title
A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
Scientific title
A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Crohn's Disease
Secondary ID [1] 0 0
2022-502050-14-00
Secondary ID [2] 0 0
M16-194
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
Treatment: Drugs - Risankizumab

Experimental: PK Cohort 1: SS1 - Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.

Experimental: PK Cohort 1: SS2 Dose A - Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.

Experimental: PK Cohort 1: SS2 Dose B - Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.

Experimental: PK Cohort 1: SS3 Dose A - Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.

Experimental: PK Cohort 1: SS3 Dose B - Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.

Experimental: PK Cohort 2: SS1 - Cohort 2 will enroll participants aged 2 to less than 6 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.

Experimental: PK Cohort 2: SS2 Dose A - Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.

Experimental: PK Cohort 2: SS2 Dose B - Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.

Experimental: PK Cohort 2: SS3 Dose A - Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.

Experimental: PK Cohort 2: SS3 Dose B - Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.

Experimental: Expansion Cohort 3: SS1 - Cohort 3 will enroll participants aged 2 to less than 18 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.

Experimental: Expansion Cohort 3: SS2 Dose A - Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive either double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.

Experimental: Expansion Cohort 3: SS2 Dose B - Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive either double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.

Experimental: Expansion Cohort 3: SS3 Dose A - Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.

Experimental: Expansion Cohort 3: SS3 Dose B - Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.


Treatment: Drugs: Risankizumab
Intravenous (IV) Infusion

Treatment: Drugs: Risankizumab
Subcutaneous (SC) Injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
Timepoint [1] 0 0
At 64 weeks
Primary outcome [2] 0 0
Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD)
Timepoint [2] 0 0
At 64 weeks
Primary outcome [3] 0 0
Cohorts 1 & 2: Maximum Observed Serum Concentration (Cmax) of Risankizumab
Timepoint [3] 0 0
Up to approximately Week 64
Primary outcome [4] 0 0
Cohorts 1 & 2: Time to Cmax (Tmax) of Risankizumab
Timepoint [4] 0 0
Up to approximately 64 weeks
Primary outcome [5] 0 0
Cohorts 1 & 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Risankizumab
Timepoint [5] 0 0
Up to approximately 64 weeks
Secondary outcome [1] 0 0
Cohort 3 (Substudy 1): Percentage of Participants Achieving PCDAI Clinical Remission
Timepoint [1] 0 0
At 12 weeks
Secondary outcome [2] 0 0
Cohort 3 (Substudy 1): Percentage of Participants Achieving Endoscopic Response per SES-CD
Timepoint [2] 0 0
At 12 weeks
Secondary outcome [3] 0 0
Cohort 3 (Substudy 1): Percentage of Participants Achieving Endoscopic Remission per SES-CD
Timepoint [3] 0 0
At 12 weeks
Secondary outcome [4] 0 0
Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Remission per SES-CD
Timepoint [4] 0 0
At 64 weeks
Secondary outcome [5] 0 0
Cohort 3 (Substudy 2): Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per PCDAI
Timepoint [5] 0 0
At 64 weeks
Secondary outcome [6] 0 0
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving PCDAI Clinical Remission
Timepoint [6] 0 0
At 64 weeks
Secondary outcome [7] 0 0
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per SES-CD
Timepoint [7] 0 0
At 64 weeks
Secondary outcome [8] 0 0
Cohorts 1 & 2 (Substudy 1): Percentage of Participants Achieving PCDAI Clinical Remission
Timepoint [8] 0 0
At 12 weeks
Secondary outcome [9] 0 0
Cohorts 1 & 2 (Substudy 1): Percentage of Participants Achieving Endoscopic Response per SES-CD
Timepoint [9] 0 0
At 12 weeks
Secondary outcome [10] 0 0
Cohorts 1 & 2 (Substudy 1): Percentage of Participants Achieving Endoscopic Remission per SES-CD
Timepoint [10] 0 0
At 12 weeks
Secondary outcome [11] 0 0
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving Endoscopic Remission per SES-CD
Timepoint [11] 0 0
At 64 weeks
Secondary outcome [12] 0 0
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per PCDAI
Timepoint [12] 0 0
At 64 weeks

Eligibility
Key inclusion criteria
* Pediatric individuals, 2 to < 18 years old
* Must have moderately to severely active CD, as defined by the PCDAI score > 30 assessed at Baseline
* Must have endoscopic evidence of mucosal inflammation as documented by the SES-CD of = 6 for ileocolonic or colonic disease (or SES-CD of = 4 for isolated ileal disease)
* Demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates (This drug class is not sufficient for eligibility for subjects in France, Italy, Netherlands, Spain, and Sweden), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), IMMs, and/or biologic therapies
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of hereditary fructose intolerance (a rare genetic condition) or an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class
* Any of the following medical disorders:

1. Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD.
2. A diagnosis of CD prior to 2 years of age.
3. A diagnosis or suspected diagnosis of a primary immunodeficiency.
4. Currently known complications of CD such as:

* Active abscess (abdominal or perianal);
* Symptomatic bowel strictures;
* > 2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum;
* Fulminant colitis;
* Toxic megacolon;
* Or any other manifestation that might require surgery while enrolled in the study.
5. Ostomy or ileoanal pouch.
6. Diagnosis of short gut or short bowel syndrome.
7. Surgical bowel resection within the past 3 months prior to Baseline (excluding gastrointestinal surgeries which are not bowel resections such as appendectomy or ostomy closure), or a history of >3 bowel resections.

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 administering 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
11/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/04/2029
Actual
Sample size
Target
110
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
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
Belgium
State/province [11] 0 0
Antwerpen
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles-Capitale
Country [13] 0 0
Belgium
State/province [13] 0 0
Vlaams-Brabant
Country [14] 0 0
Belgium
State/province [14] 0 0
Bruxelles
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Plovdiv
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Sofiya
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Varna
Country [18] 0 0
Czechia
State/province [18] 0 0
Prague
Country [19] 0 0
Czechia
State/province [19] 0 0
Praha
Country [20] 0 0
France
State/province [20] 0 0
Centre-Val De Loire
Country [21] 0 0
France
State/province [21] 0 0
Nouvelle-Aquitaine
Country [22] 0 0
France
State/province [22] 0 0
Rhone
Country [23] 0 0
France
State/province [23] 0 0
Toulouse
Country [24] 0 0
Germany
State/province [24] 0 0
Nordrhein-Westfalen
Country [25] 0 0
Germany
State/province [25] 0 0
Saarland
Country [26] 0 0
Israel
State/province [26] 0 0
HaMerkaz
Country [27] 0 0
Israel
State/province [27] 0 0
Yerushalayim
Country [28] 0 0
Italy
State/province [28] 0 0
L Aquila
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Seoul Teugbyeolsi
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Daegu
Country [31] 0 0
Netherlands
State/province [31] 0 0
Noord-Holland
Country [32] 0 0
Poland
State/province [32] 0 0
Kujawsko-pomorskie
Country [33] 0 0
Poland
State/province [33] 0 0
Mazowieckie
Country [34] 0 0
Puerto Rico
State/province [34] 0 0
Dorado
Country [35] 0 0
Puerto Rico
State/province [35] 0 0
San Juan
Country [36] 0 0
Spain
State/province [36] 0 0
A Coruna
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Spain
State/province [38] 0 0
Malaga
Country [39] 0 0
Sweden
State/province [39] 0 0
Stockholms Lan
Country [40] 0 0
Switzerland
State/province [40] 0 0
Zuerich
Country [41] 0 0
Switzerland
State/province [41] 0 0
Bern
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taipei
Country [43] 0 0
Taiwan
State/province [43] 0 0
Changhua City, Changhua County
Country [44] 0 0
Turkey
State/province [44] 0 0
Adana
Country [45] 0 0
Turkey
State/province [45] 0 0
Ankara
Country [46] 0 0
United Kingdom
State/province [46] 0 0
England
Country [47] 0 0
United Kingdom
State/province [47] 0 0
London, City Of

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/NCT05995353