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New study checks if IBD drug skyrizi seeps into breast milk

NCT ID NCT06346288

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how much of the drug risankizumab (Skyrizi) passes into the breast milk of women with inflammatory bowel disease (IBD). Ten breastfeeding mothers who were already taking the drug provided milk samples over several weeks. The goal is to understand potential exposure to nursing infants and help guide safe breastfeeding recommendations.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
risankizumab (Skyrizi)
What this could lead to
If successful, this study could provide data to help doctors and mothers make informed decisions about breastfeeding while on risankizumab.
What could go wrong
This is a small, observational study with only 10 participants. It measures drug levels in milk but does not directly test infant safety or long-term outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

10 people

The number who actually took part.

Started

Apr 2024

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant must have received at least 2 doses of 360 mg risankizumab maintenance therapy every 8 weeks postpartum prior to start of participation in this study. * Participant is at least 5 weeks postpartum by Day 1. * Lactation is well established. The mother must be exclusively breastfeeding her infant (or not providing more than 1 supplemental bottle of formula/day) when enrolled in the study. * Diagnosis of crohn's disease (or ulcerative colitis upon approval of ulcerative colitis in the participants location) as established by the principal investigator Exclusion Criteria: * Participants who have major surgery planned during the conduct of the study (e.g., hip replacement, aneurysm removal, stomach ligation) * Participants with the following chronic or active infections: \-- Active HBV or HCV infection, defined as: * HBV: HBs Ag positive (+) test or detected sensitivity on the HBV DNA PCR qualitative test for participants who are HBc Ab positive (+) (and for HBs Ab positive \[+\] participants where mandated by local requirements). * HCV: HCV RNA detectable in any subject with HCV Ab. * Are infected with HIV, defined as confirmed positive anti-HIV Ab test. Note: In case a screened participant has a confirmed positive HIV Ab test,. * Active tuberculosis * Active systemic infection/clinically important infection during the last 2 weeks prior to the Baseline Visit as assessed by the investigator * Participants who have any of the following medical diseases or conditions: * Recent (within past 6 months) cerebrovascular accident or myocardial infarction; * History of an organ transplant which requires continued immunosuppression; * Active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Shaare Zedek Medical Center /ID# 262738

    Jerusalem, Jerusalem, 91031, Israel

  • UTHealth Women's Research Program - Memorial City /ID# 263939

    Houston, Texas, 77024, United States

  • University of North Carolina at Chapel Hill /ID# 263316

    Chapel Hill, North Carolina, 27514, United States

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