Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06332534
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-03-19
Brief Title:
Crohns Disease Efficacy Safety and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohns Disease
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official 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 Crohns Disease and Inadequate Response Intolerance or Medical Contraindications to Corticosteroids Immunosuppressants andor Biologic Therapy
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Crohns 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 oral Upadacitinib is in treating moderately to severely active Crohns Disease in pediatric participants aged 2 to 18 years old who have had inadequate response loss of response intolerance or medical contraindications to corticosteroids immunosuppressants andor biologic therapy
Upadacitinib RINVOQ is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants This study is conducted in 2 periods Period 1 is comprised of two phases a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A or the adult equivalent based on body weight followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be givenUPA Dose B or Dose C Period 2 is a 156-week open-label extension of Period 1 Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 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 have a safety follow up for 30 days after discontinuation from any time point within the study
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures Participants will attend regular weekly monthly 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
Upadacitinib RINVOQ is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants This study is conducted in 2 periods Period 1 is comprised of two phases a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A or the adult equivalent based on body weight followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be givenUPA Dose B or Dose C Period 2 is a 156-week open-label extension of Period 1 Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 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 have a safety follow up for 30 days after discontinuation from any time point within the study
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures Participants will attend regular weekly monthly 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None