AbbVie’s SKYRIZI Lactation Study Completion Adds Quiet Support to Its IBD Growth Story

Abbvie (ABBV) announced an update on their ongoing clinical study.

AbbVie (ABBV) has updated a Phase 4 lactation study titled “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.” The main goal is to measure how much of the drug enters breast milk in women with inflammatory bowel disease, which can help guide real-world use in nursing mothers.

The study tracks risankizumab, sold as SKYRIZI, an injectable biologic already approved for plaque psoriasis, psoriatic arthritis, and Crohn’s disease. Women stay on their usual maintenance dosing and the research team only collects breast milk samples and safety data, aiming to clarify safety and exposure levels for infants.

This is an interventional Phase 4 study with a single group and no randomization or placebo. It is open-label, meaning both doctors and participants know the treatment being used, and the main purpose is to answer a specific safety and exposure question rather than to test if the drug works.

The trial involves around 10 lactating women with inflammatory bowel disease at sites in Israel and the U.S. The design is simple: women already on SKYRIZI keep their treatment, attend scheduled clinic visits for milk sampling and basic checks, and complete questionnaires over about seven months.

The study began enrolling in 2024 after first submission on March 22, 2024, and is now listed as completed, reflecting that patient visits and sampling are finished. The record was last updated on February 25, 2026, signaling that AbbVie has refreshed the public information, often a precursor to upcoming data disclosure.

While primary and final completion dates are not listed, completion status means the main data set is likely locked or close to analysis. For investors, this timing suggests that a safety readout on breastfeeding exposure could emerge in the near term and may be used in future label or guideline discussions.

Marketwise, this update supports AbbVie’s long-term strategy to deepen SKYRIZI’s moat in inflammatory bowel disease. Clear data showing low transfer into breast milk could ease physician and patient concerns, supporting broader use in women of childbearing age and reinforcing recurring revenue in Crohn’s disease.

Competitors such as Johnson & Johnson, Pfizer, and others with biologics in IBD have limited lactation data, so any positive findings may give AbbVie a subtle but real marketing edge. Even though the study is small, it aligns with a safety-first narrative that tends to be well received by regulators, payers, and long-term investors.

Investor sentiment may not shift on this study alone, but it adds to a pattern of life-cycle work around SKYRIZI that supports AbbVie’s diversification beyond Humira. For income and growth investors, this kind of post-approval research helps de-risk the IBD franchise and can modestly support valuation multiples over time.

The study is completed with a recent update on the ClinicalTrials portal, and detailed results and interpretations will be available there as AbbVie discloses more information.

To learn more about ABBV’s potential, visit the Abbvie drug pipeline page.