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NCT06346288 · ClinicalTrials.gov registry record · Phase 4
A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease
A Phase 4 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT06346288: Completed Phase 4 study, sponsored by AbbVie.
NCT06346288 is a Phase 4 study that has completed, run by AbbVie. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06346288, a Phase 4 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study 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 Crohn's 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.
Primary Outcome
Breastmilk samples will be collected to evaluate the presence of risankizumab in the milk of lactating women
Interventions
- DRUG Risankizumab
- PROCEDURE Breast Milk Sampling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-04-24 |
| Est. Completion | 2026-02-05 |
| Phase | Phase 4 |
What the finished NCT06346288 record still lists
NCT06346288 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Risankizumab is the first listed.
NCT06346288 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06346288 about?
NCT06346288 is a clinical study titled "A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease". 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 Cr...
What is the current status of trial NCT06346288?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2024-04-24. Estimated completion is 2026-02-05.
What interventions are being tested in trial NCT06346288?
The interventions under investigation include: Risankizumab (DRUG), Breast Milk Sampling (PROCEDURE).
Who is sponsoring clinical trial NCT06346288?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06346288's enrollment target sits among peer trials
10 1940th of 2000 higher than 33 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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