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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06332534




Registration number
NCT06332534
Ethics application status
Date submitted
19/03/2024
Date registered
27/03/2024

Titles & IDs
Public title
Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
Scientific title
A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib With Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects With Moderately to Severely Active Crohn's Disease and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy
Secondary ID [1] 0 0
M14-671
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 - Upadacitinib

Experimental: Period 1: Open Label Induction Phase (Dose A) - All participants in the open label induction phase of Period 1 will receive upadacitinib Dose A for 12 weeks based on body weight.

Experimental: Period 1: Double-Blind Maintenance Phase (Dose B) - Clinical responders per PCDAI at the end of open label induction phase of Period 1 will be randomly assigned to receive Dose B or C for 52 weeks (oral solution dose will be based on body weight)

Experimental: Period 1: Double-Blind Maintenance Phase (Dose C) - Clinical responders per PCDAI at the end of open label induction phase of Period 1 will be randomly assigned to receive either upadacitinib Dose C or B for 52 weeks (oral solution dose will be based on body weight)

Experimental: Period 2: Open Label Long-Term Extension Phase Cohort 1 - Participants receiving double-blind maintenance therapy with upadacitinib Dose B or upadacitinib Dose C daily in Period 1 who complete the Week 64 visit will receive upadacitinib Dose B daily for up to 156 weeks.

Experimental: Period 2: Open Label Long-Term Extension Phase Cohort 2 - Participants who were receiving rescue therapy with open-label upadacitinib Dose C during maintenance phase in Period 1 and completed the Week 64 visit will continue to receive upadacitinib Dose C daily for up to 156 weeks.

Experimental: Period 2: Open Label Long-Term Extension Phase Cohort 3 - Participants who did not achieve clinical response per PCDAI at Week 12 of Period 1 will receive an extended treatment with open-label upadacitinib Dose C daily for an additional 12 weeks. If they are responders after 12 weeks extended treatment, they will continue, otherwise they may be discontinued at the discretion of the investigator


Treatment: Drugs: Upadacitinib
Oral Solution/ Extended-Release Tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants who achieved clinical response per the Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12, with clinical remission per the PCDAI at Week 64
Timepoint [1] 0 0
At Week 64
Primary outcome [2] 0 0
Achievement of endoscopic response at Week 64 in participants who achieved clinical response per PCDAI at Week 12.
Timepoint [2] 0 0
At Week 64
Primary outcome [3] 0 0
Number of Participants with Adverse Events
Timepoint [3] 0 0
Through Week 156
Secondary outcome [1] 0 0
Achievement of clinical remission per PCDAI
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Achievement of endoscopic response
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Achievement of endoscopic remission
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Achievement of clinical response per PCDAI
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Achievement of clinical response per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12
Timepoint [5] 0 0
Week 64
Secondary outcome [6] 0 0
Achievement of endoscopic remission at Week 64 in participants who achieved clinical response per PCDAI at Week 12
Timepoint [6] 0 0
Week 64
Secondary outcome [7] 0 0
Achievement of corticosteroid (CS)-free clinical remission per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12
Timepoint [7] 0 0
Week 64

Eligibility
Key inclusion criteria
* Weight at Screening and Baseline must be = 10 kg
* Moderate to severe CD defined as PCDAI > 30 and endoscopic evidence of mucosal inflammation as documented by a centrally read SES-CD of >/ 6 (or SES-CD of >/4 for isolated ileal disease) excluding the presence of narrowing component.
* Documented diagnosis of CD prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of CD, in the assessment of the investigator, must be available
* Demonstrated an inadequate response, loss of response, or intolerance to corticosteroids, IMMs, and/or biologic therapy or in whom use of those therapies is medically contraindicated. For participants in the US, participants must have demonstrated an inadequate response, loss or response, or intolerance to one or more anti-TNFs (tumor necrosis factor).
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of:

* A diagnosis of CD prior to 2 years of age.
* Currently known complications of CD such as:
* Active abscess (abdominal or perianal);
* Symptomatic bowel strictures;
* More than 2 missing segments of the following 5 intestinal segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum;
* Ostomy or ileoanal pouch;
* Surgical bowel resection within the past 3 months prior to Baseline, or a history of more than 3 bowel resections.
* Japan participants only: positive result of beta-D-glucan or two consecutive indeterminate results of beta-D-glucan during the Screening period (screening for Pneumocystis jiroveci infection)
* History of any of the following:

* Current diagnosis of UC, indeterminate colitis, or monogenic IBD;
* Fulminant colitis or toxic megacolon;
* Gastrointestinal perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment including history of volvulus and/or intussusception (telescoping of bowels);
* Current diagnosis of any primary immune deficiency
* Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; subjects with a history of gastric banding/segmentation are not excluded.

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
26/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2034
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Children's Hospital at Westmead /ID# 262350 - Westmead
Recruitment hospital [2] 0 0
Queensland Children's Hospital /ID# 262351 - South Brisbane
Recruitment hospital [3] 0 0
Monash Health - Monash Medical Centre /ID# 262878 - Clayton
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Plovdiv
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Sofiya
Country [8] 0 0
France
State/province [8] 0 0
Rhone
Country [9] 0 0
France
State/province [9] 0 0
Caen
Country [10] 0 0
Greece
State/province [10] 0 0
Kriti
Country [11] 0 0
Japan
State/province [11] 0 0
Chiba
Country [12] 0 0
Japan
State/province [12] 0 0
Fukuoka
Country [13] 0 0
Japan
State/province [13] 0 0
Miyagi
Country [14] 0 0
Japan
State/province [14] 0 0
Osaka
Country [15] 0 0
Japan
State/province [15] 0 0
Saga
Country [16] 0 0
Japan
State/province [16] 0 0
Saitama
Country [17] 0 0
Japan
State/province [17] 0 0
Tokyo
Country [18] 0 0
Japan
State/province [18] 0 0
Toyama
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul Teugbyeolsi
Country [20] 0 0
New Zealand
State/province [20] 0 0
Canterbury
Country [21] 0 0
New Zealand
State/province [21] 0 0
Auckland
Country [22] 0 0
Poland
State/province [22] 0 0
Kujawsko-pomorskie
Country [23] 0 0
Poland
State/province [23] 0 0
Mazowieckie
Country [24] 0 0
Puerto Rico
State/province [24] 0 0
Bayamon
Country [25] 0 0
Puerto Rico
State/province [25] 0 0
Dorado
Country [26] 0 0
Spain
State/province [26] 0 0
A Coruna
Country [27] 0 0
Spain
State/province [27] 0 0
Barcelona
Country [28] 0 0
Spain
State/province [28] 0 0
Malaga
Country [29] 0 0
Spain
State/province [29] 0 0
Sevilla
Country [30] 0 0
Spain
State/province [30] 0 0
Zaragoza
Country [31] 0 0
Taiwan
State/province [31] 0 0
Taipei
Country [32] 0 0
Taiwan
State/province [32] 0 0
Taoyuan City
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Cambridgeshire
Country [34] 0 0
United Kingdom
State/province [34] 0 0
England
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Greater London
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Norfolk
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Edinburgh

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/NCT06332534