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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522362-78-00

Enrollment

Registered

2026-04-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

Concentration of mirikizumab in breast milk predose on Day 0, as well as each day that breast milk collection is indicated in the SoA (Section 1.3).

Detailed description

AUC(0-τ), Cavg, Ctrough, Cmax, and tmax, Infant weight and caregiver- or HCP-reported adverse events.

Interventions

DRUGOmvoh 100 mg + 200 mg solution for injection in pre-filled syringe

DRUGOmvoh 100 mg + 200 mg solution for injection in pre-filled pen

DRUGOmvoh 100 mg solution for injection in pre-filled syringe

DRUGOmvoh 100 mg solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Concentration of mirikizumab in breast milk predose on Day 0, as well as each day that breast milk collection is indicated in the SoA (Section 1.3).	—

Secondary

Measure	Time frame
AUC(0-τ), Cavg, Ctrough, Cmax, and tmax, Infant weight and caregiver- or HCP-reported adverse events.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 29, 2026