AuthorisedTherapeutic use (Phase IV)Interventional

A Study to Evaluate Mirikizumab Concentrations in Breast Milk Following Administration of Mirikizumab by Subcutaneous Injection in Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication

This study is for mothers who are breastfeeding and taking a medicine called Omvoh (mirikizumab) for conditions like ulcerative colitis (a bowel problem) or Crohn's disease. Researchers want to find out how much of the Omvoh medicine passes into breast milk. This is important information to understand if babies might be exposed to the medicine through breastfeeding and in what amounts. By understanding this, doctors can give better advice to breastfeeding mothers who need to take Omvoh. The study also looks at the babies' weight and any health problems they might have, as reported by parents or healthcare staff.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Eli Lilly & Co.

Enrolment target

Start

27 Apr 2026

severely active ulcerative colitis (US) and CD (Crohn’s disease)

What is this study about?

This study is called a 'post-market' study (or Phase IV), which means the medicine, Omvoh (mirikizumab), is already approved and being used by people. The focus of this particular study is for mothers who are breastfeeding and using Omvoh to treat conditions like ulcerative colitis or Crohn's disease. These are long-lasting conditions that cause inflammation in the gut.

The main goal is to measure how much Omvoh medicine gets into breast milk. This helps doctors and scientists understand if babies are exposed to the medicine through breastfeeding. Knowing this information is very important for mothers who need to take Omvoh and also want to breastfeed their babies. It helps healthcare professionals provide the best and safest advice.

Researchers will also be monitoring the babies involved in the study. They will regularly check their weight and record any health issues or problems that are noticed by their parents or by healthcare staff. This helps to build a complete picture of the medicine's presence in breast milk and any potential effects on the baby.

Key takeaways

This study investigates Omvoh levels in breast milk.
It's for breastfeeding mothers with ulcerative colitis or Crohn's.
Participation involves collecting breast milk samples.
Researchers will monitor babies' weight and health.
The findings will help guide future guidance for breastfeeding mothers.
It is a 'real-world' study for an approved medicine.

Who may be eligible?

This study is looking for women who are at least 18 years old and are currently breastfeeding.

You must also be taking the medicine Omvoh (mirikizumab) as part of your regular treatment for either ulcerative colitis or Crohn's disease. Your doctor will be able to tell you if you meet all the specific requirements for joining the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Are you currently breastfeeding?
Are you taking Omvoh (mirikizumab) for ulcerative colitis or Crohn's disease?
Do you want to help future breastfeeding mothers make informed decisions?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to take your Omvoh medicine as prescribed by your doctor. The main part of your participation will involve collecting samples of your breast milk at specific times, including before your Omvoh dose on Day 0 and on other set days during the study. You will be given clear instructions on how and when to collect these samples.

Researchers will also collect information about your Omvoh doses. For your baby, their weight will be checked regularly during the study. You, or your baby's doctor, will also be asked to report any health problems or side effects your baby might experience while you are taking Omvoh and participating in the study. The total duration of your participation will depend on the study schedule, but it involves regular engagement over a period to collect these samples and observations.

Potential risks and benefits

The potential benefit of joining this study is contributing valuable information that will help many other breastfeeding mothers who need to take Omvoh for their health conditions. This information can help doctors give better and safer advice about breastfeeding while on this medication. Potential risks are generally low, as you would already be taking Omvoh; however, the act of collecting breast milk samples could be an inconvenience. Any health issues noticed in your baby will be carefully monitored. You have the right to withdraw from the study at any time without it affecting your medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Denmark
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Unverified
Germany
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Unverified
Italy
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Unverified
Poland

Common questions

What is the main goal of this study?

The main goal is to measure how much of the Omvoh medicine gets into breast milk when a mother is breastfeeding.

What medicines are involved?

The study focuses on the medicine Omvoh (mirikizumab), which is used to treat ulcerative colitis and Crohn's disease.

Who can take part in this study?

Women who are 18 or older, breastfeeding, and already taking Omvoh for ulcerative colitis or Crohn's disease.

What will I need to do if I join?

You'll need to collect breast milk samples at certain times and allow researchers to monitor your baby's weight and any health issues.

Will this study help me directly?

While it might not directly change your current treatment, your participation will provide important information to help other breastfeeding mothers in the future.