Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346288
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-03-22
Brief Title:
A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 4 Open-Label Milk-Only Lactation Study to Assess Concentration of Risankizumab in Breast Milk of Lactating Women With Inflammatory Bowel Disease Who Are Receiving Risankizumab Therapeutically
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Inflammatory bowel disease IBD is a chronic inflammatory disease that requires lifelong treatment This study will asses the concentrations of risankizumab in the breast milk of lactating women with IBD
Risankizumab is an approved drug for adults with plaque psoriasis psoriatic arthritis and Crohns Disease This is an open-label milk-only study lactation study to evaluate the presence of risankizumab in the milk of lactating women Approximately 10 adult lactating women with IBD will be enrolled from approximately 3 sites in Israel and or the United States
Participants will receive risakizumab maintenance therapy every 8 weeks postpartum prior to start of participation in this study The study duration is approximately 7 months
Participants will attend regular visits during the study at a hospital or clinic The participants will also be completing questionnaires and will have medical assessments checking for side effects
Risankizumab is an approved drug for adults with plaque psoriasis psoriatic arthritis and Crohns Disease This is an open-label milk-only study lactation study to evaluate the presence of risankizumab in the milk of lactating women Approximately 10 adult lactating women with IBD will be enrolled from approximately 3 sites in Israel and or the United States
Participants will receive risakizumab maintenance therapy every 8 weeks postpartum prior to start of participation in this study The study duration is approximately 7 months
Participants will attend regular visits during the study at a hospital or clinic The participants will also be completing questionnaires and will have medical assessments checking for side effects
Detailed Description:
The study will only include lactating women who are receiving treatment with risankizumab for IBD in accordance with their treating physician although this study is non-interventional regarding treatment with risankizumab it is considered interventional due to the collection of breast milk from the lactating mothers
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?:
False
Is an FDA AA801 Violation?:
None