Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548542
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohns Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2a Multicenter Randomized Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohns Disease
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Target CD
Brief Summary:
Crohns disease CD is a long-lasting disease that causes severe inflammation redness swelling in the digestive tract most frequently affecting the bowels It can cause many different symptoms including belly pain diarrhea tiredness and weight loss Treatments are available but do not work the same for all patients or may stop working over time This study will evaluate the effectiveness and adverse events of targeted therapies TaTs for adult participants with moderate to severe CD
The medicines assessed in this study are risankizumab ABBV-382 and lutikizumab When participants join the study they will be randomized into available study treatment groups Adult participants with CD will be enrolled Around 500 participants will be enrolled in the study at approximately 300 sites worldwide
Risankizumab and ABBV-382 are given as an injection under the skin or as an infusion into the vein Lutikizumab is given as an injection under the skin Each group includes a 12-week induction period a 12-week maintenance period and an optional long-term extension period where medication will be given after the maintenance period
There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study 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 endoscopies checking for side effects and completing questionnaires and a daily diary
The medicines assessed in this study are risankizumab ABBV-382 and lutikizumab When participants join the study they will be randomized into available study treatment groups Adult participants with CD will be enrolled Around 500 participants will be enrolled in the study at approximately 300 sites worldwide
Risankizumab and ABBV-382 are given as an injection under the skin or as an infusion into the vein Lutikizumab is given as an injection under the skin Each group includes a 12-week induction period a 12-week maintenance period and an optional long-term extension period where medication will be given after the maintenance period
There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study 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 endoscopies checking for side effects and completing questionnaires and a daily diary
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None