Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05782907
Registration number
NCT05782907
Ethics application status
Date submitted
13/03/2023
Date registered
24/03/2023
Titles & IDs
Public title
Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.
Query!
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 Ulcerative Colitis and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy
Query!
Secondary ID [1]
0
0
2022-501788-41-00
Query!
Secondary ID [2]
0
0
M14-658
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Inflammatory bowel disease
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Upadacitinib
Experimental: Period 1- Open Label Induction Phase - All participants in open label induction phase of Period 1 will receive upadacitinib Dose A for 8 weeks based on body weight.
Experimental: Period 1- Double Blind Maintenance Phase - Clinical responders at the end of open label induction phase of Period 1 will be randomly assigned to receive either upadacitinib Dose B or Dose C for 44 weeks based on body weight.
Experimental: Period 2- Open Label Long Term Extension Phase Arm A - Clinical non-responders outside of US after Period 1 induction phase will receive upadacitinib Dose A daily for 8 week extended induction phase in open label long term extension (OLE) Period 2. Clinical responders from extended induction phase in OLE will receive upadacitinib Dose B daily for up to 252 weeks in OLE period 2.
Experimental: Period 2- Open Label Long Term Extension Phase Arm B - Clinical non-responders in US after Period 1 induction phase or clinical responders with loss of response during maintenance phase will receive upadacitinib Dose B daily for up to 260 weeks in OLE Period 2.
Experimental: Period 2- Long Term Extension Phase Arm C - Clinical responders who complete Period 1 through Week 52 will receive upadacitinib Dose C daily for up to 260 weeks in OLE Period 2.
Treatment: Drugs: Upadacitinib
Oral Solution/ Tablets
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants Achieving Adapted Mayo score (AMS) Clinical Remission (Period 1)
Query!
Assessment method [1]
0
0
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The AMS is a composite of the following subscores: stool frequency subscore (SFS), rectal bleeding subscore (RBS) and endoscopy subscore (MES). AMS ranges from 0 to 9 where higher scores represent more severe disease. Clinical remission is defined as an AMS \< or = 2, with SFS \< or = 1 and not higher than baseline, RBS of 0, and MES \< or = 1.
Query!
Timepoint [1]
0
0
Week 8
Query!
Primary outcome [2]
0
0
Percentage of Participants Achieving AMS Clinical Remission Among Week 8 Responders per AMS (Period 1)
Query!
Assessment method [2]
0
0
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. AMS ranges from 0 to 9 where higher scores represent more severe disease. Clinical remission is defined as an AMS = 2, with SFS = 1 and not higher than Baseline, RBS of 0, and MES = 1.
Query!
Timepoint [2]
0
0
Week 52
Query!
Secondary outcome [1]
0
0
Percentage of Participants Achieving Endoscopic Improvement (Period 1)
Query!
Assessment method [1]
0
0
Endoscopic Improvement is defined as MES \< or = 1.
Query!
Timepoint [1]
0
0
Week 8
Query!
Secondary outcome [2]
0
0
Percentage of Participants Achieving Partial Mayo Score (PMS) Clinical Remission (Period 1)
Query!
Assessment method [2]
0
0
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The PMS is a composite of the following subscores: SFS, RBS and physician's global assessment (PGA). The PMS ranges from 0 to 9 with higher scores representing more severe disease. PMS clinical remission is defined as a PMS \< or = 2 and no individual subscore \> 1.
Query!
Timepoint [2]
0
0
Week 8
Query!
Secondary outcome [3]
0
0
Percentage of Participants Achieving AMS Clinical Response (Period 1)
Query!
Assessment method [3]
0
0
The adapted mayo score (AMS) is a composite of the following subscores: SFS, RBS and MES. AMS clinical response is defined as decrease in AMS by \> or = 2 points and \> or = 30% from baseline with a decrease in RBS of \> or = 1 or an absolute RBS of 0 or 1.
Query!
Timepoint [3]
0
0
Week 8
Query!
Secondary outcome [4]
0
0
Percentage of Participants Achieving Endoscopic Improvement Among Week 8 Responders per AMS (Period 1)
Query!
Assessment method [4]
0
0
Endoscopic Improvement is defined as MES of \< or = 1. The AMS is a composite of the following subscores: SFS, RBS and MES.
Query!
Timepoint [4]
0
0
Week 52
Query!
Secondary outcome [5]
0
0
Percentage of Participants Achieving PMS Clinical Remission Among Week 8 Responders per AMS (Period 1)
Query!
Assessment method [5]
0
0
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The PMS ranges from 0 to 9 with higher scores representing more severe disease. PMS clinical remission is defined as a PMS \< or = 2 and no individual subscore \> 1. The AMS is a composite of the following subscores: SFS, RBS and MES.
Query!
Timepoint [5]
0
0
Week 52
Query!
Secondary outcome [6]
0
0
Percentage of Participants Achieving AMS Clinical Response Among Week 8 Responders per AMS (Period 1)
Query!
Assessment method [6]
0
0
The AMS is a composite of the following subscores: SFS, RBS and MES. AMS clinical response is defined as decrease in AMS by \> or = 2 points and \> or = 30% from baseline with a decrease in RBS of \> or = 1 or an absolute RBS of 0 or 1.
Query!
Timepoint [6]
0
0
Week 52
Query!
Secondary outcome [7]
0
0
Percentage of Participants Achieving PMS Clinical Response Among Week 8 Clinical Responders per AMS (Period 1)
Query!
Assessment method [7]
0
0
The AMS is a composite of the following subscores: SFS, RBS and endoscopy MES. PMS clinical response is defined as decrease in PMS by \> or = 2 points and \> or = 30% from baseline with a decrease in RBS \> or = 1 or an absolute RBS of 0 or 1.
Query!
Timepoint [7]
0
0
Week 52
Query!
Secondary outcome [8]
0
0
Percentage of Participants Achieving Corticosteroid-Free AMS Clinical Remission Among Week 8 Responders per AMS (Period 1)
Query!
Assessment method [8]
0
0
Corticosteroid-free AMS clinical remission is defined as being in AMS clinical remission and free of corticosteroids for \>= 90 days immediately preceeding the timepoint of endpoint assessment. The AMS is a composite of the following subscores: SFS, RBS and MES.
Query!
Timepoint [8]
0
0
Week 52
Query!
Secondary outcome [9]
0
0
Percentage of Participants Achieving AMS Clinical Remission Among Week 8 Remitters per AMS (Period 1)
Query!
Assessment method [9]
0
0
The AMS is a composite of the following subscores: SFS, RBS and MES. Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical remission is defined as an AMS \< or = 2, with SFS \< or = 1 and not higher than baseline, RBS of 0, and MES \< or = 1.
Query!
Timepoint [9]
0
0
Week 52
Query!
Eligibility
Key inclusion criteria
* Active UC with an AMS of 5 to 9 points and endoscopic subscore of 2 to 3.
* Demonstrate an inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy.
Query!
Minimum age
2
Years
Query!
Query!
Maximum age
17
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Partcipants with previous exposure to JAK inhibitors (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
* Females who are pregnant, breastfeeding, or considering becoming pregnant during the study and for approximately 30 days after the last dose of study drug.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
6/11/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/10/2033
Query!
Actual
Query!
Sample size
Target
110
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NT,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Children's Hospital at Westmead /ID# 255556 - Westmead
Query!
Recruitment hospital [2]
0
0
Queensland Children's Hospital /ID# 261032 - South Brisbane
Query!
Recruitment hospital [3]
0
0
Monash Medical Centre /ID# 254726 - Clayton
Query!
Recruitment hospital [4]
0
0
Perth Children'S Hospital /ID# 254727 - Perth
Query!
Recruitment postcode(s) [1]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [2]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [3]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [4]
0
0
6009 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Delaware
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Massachusetts
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New York
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
North Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Ohio
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Virginia
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Vlaams-Brabant
Query!
Country [14]
0
0
Bulgaria
Query!
State/province [14]
0
0
Plovdiv
Query!
Country [15]
0
0
Bulgaria
Query!
State/province [15]
0
0
Sofiya
Query!
Country [16]
0
0
Bulgaria
Query!
State/province [16]
0
0
Varna
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Alberta
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Nouvelle-Aquitaine
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Rhone
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Paris
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Toulouse
Query!
Country [22]
0
0
Greece
Query!
State/province [22]
0
0
Attiki
Query!
Country [23]
0
0
Greece
Query!
State/province [23]
0
0
Kriti
Query!
Country [24]
0
0
Hungary
Query!
State/province [24]
0
0
Hajdu-Bihar
Query!
Country [25]
0
0
Hungary
Query!
State/province [25]
0
0
Budapest
Query!
Country [26]
0
0
Israel
Query!
State/province [26]
0
0
HaMerkaz
Query!
Country [27]
0
0
Israel
Query!
State/province [27]
0
0
Yerushalayim
Query!
Country [28]
0
0
Italy
Query!
State/province [28]
0
0
Firenze
Query!
Country [29]
0
0
Italy
Query!
State/province [29]
0
0
Roma
Query!
Country [30]
0
0
Italy
Query!
State/province [30]
0
0
Bologna
Query!
Country [31]
0
0
Japan
Query!
State/province [31]
0
0
Chiba
Query!
Country [32]
0
0
Japan
Query!
State/province [32]
0
0
Fukuoka
Query!
Country [33]
0
0
Japan
Query!
State/province [33]
0
0
Hokkaido
Query!
Country [34]
0
0
Japan
Query!
State/province [34]
0
0
Miyagi
Query!
Country [35]
0
0
Japan
Query!
State/province [35]
0
0
Osaka
Query!
Country [36]
0
0
Japan
Query!
State/province [36]
0
0
Saitama
Query!
Country [37]
0
0
Japan
Query!
State/province [37]
0
0
Tokyo
Query!
Country [38]
0
0
Korea, Republic of
Query!
State/province [38]
0
0
Seoul Teugbyeolsi
Query!
Country [39]
0
0
Korea, Republic of
Query!
State/province [39]
0
0
Daegu
Query!
Country [40]
0
0
Netherlands
Query!
State/province [40]
0
0
Noord-Holland
Query!
Country [41]
0
0
Netherlands
Query!
State/province [41]
0
0
Groningen
Query!
Country [42]
0
0
New Zealand
Query!
State/province [42]
0
0
Auckland
Query!
Country [43]
0
0
New Zealand
Query!
State/province [43]
0
0
Canterbury
Query!
Country [44]
0
0
Poland
Query!
State/province [44]
0
0
Kujawsko-pomorskie
Query!
Country [45]
0
0
Poland
Query!
State/province [45]
0
0
Mazowieckie
Query!
Country [46]
0
0
Spain
Query!
State/province [46]
0
0
A Coruna
Query!
Country [47]
0
0
Spain
Query!
State/province [47]
0
0
Barcelona
Query!
Country [48]
0
0
Spain
Query!
State/province [48]
0
0
Malaga
Query!
Country [49]
0
0
Taiwan
Query!
State/province [49]
0
0
Taipei
Query!
Country [50]
0
0
Taiwan
Query!
State/province [50]
0
0
Taoyuan City
Query!
Country [51]
0
0
United Kingdom
Query!
State/province [51]
0
0
England
Query!
Country [52]
0
0
United Kingdom
Query!
State/province [52]
0
0
Hampshire
Query!
Country [53]
0
0
United Kingdom
Query!
State/province [53]
0
0
London, City Of
Query!
Country [54]
0
0
United Kingdom
Query!
State/province [54]
0
0
Birmingham
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AbbVie
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective Upadacitinib is in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active UC and is being developed for moderate- to severely active UC in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: an 8-week open-label induction phase which means that the study doctor and patients know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 44-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 260 week open-label extension (OLE) of Period 1. Approximately 110 pediatric participants with moderate to severely active UC will be enrolled at up to 100 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will be followed up for 30 days after each phase (i.e. after induction, maintenance, OLE) and only if a participant doesn't continue into the next phase. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05782907
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
ABBVIE INC.
Query!
Address
0
0
AbbVie
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
ABBVIE CALL CENTER
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
844-663-3742
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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)
Query!
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Query!
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/
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
Query!
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/NCT05782907