Lebrikizumab Pregnancy Study Opens for Atopic Dermatitis

MotherToBaby has launched a new observational pregnancy study evaluating lebrikizumab-lbkz (Ebglyss; Eli Lilly and Company) in women with moderate to severe atopic dermatitis (AD). The study, announced August 13, 2026, is enrolling pregnant participants across the United States and Canada.¹

Christina D. Chambers, PhD, MPH, professor of pediatrics at UC San Diego School of Medicine, is leading the research, which aims to address limited human pregnancy data for lebrikizumab.¹

Lebrikizumab, an interleukin (IL)-13 inhibitor, received FDA approval in September 2024 for the treatment of moderate-to-severe AD in adults and pediatric patients 12 years and older who weigh at least 40 kg and whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.²

For clinicians treating patients who are pregnant or may become pregnant, however, evidence regarding lebrikizumab exposure remains limited.

How the Pregnancy Study Will Evaluate Lebrikizumab

The MotherToBaby Ebglyss Pregnancy Study will follow participants throughout pregnancy and after delivery to assess pregnancy and infant outcomes associated with lebrikizumab exposure.¹

Researchers will compare women who received at least 1 dose of lebrikizumab in the months before or during pregnancy with women with AD who received other systemic treatments or phototherapy and women with AD who received no systemic treatment during pregnancy. The comparison groups are intended to help investigators better understand outcomes potentially associated with medication exposure as well as the underlying disease.¹

The study is observational, meaning participants will not be asked to take a study medication or alter treatment recommended by their health care providers. Instead, researchers will collect health information through interviews and medical record review with participants' permission.

Enrollment is expected to continue through 2033.¹

What Current Prescribing Information Says About Pregnancy

Current lebrikizumab-lbkz prescribing information states that available data from case reports involving use in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.³

The prescribing information also notes that human IgG antibodies are known to cross the placental barrier and that lebrikizumab may therefore be transmitted from the mother to the developing fetus.³

These limitations underscore a broader challenge when introducing newer therapies into clinical practice: pregnancy-specific evidence may remain limited even after a treatment becomes available to the general patient population.

Who Is Eligible to Participate?

MotherToBaby is seeking pregnant individuals across the United States and Canada who have used lebrikizumab during pregnancy, as well as pregnant individuals diagnosed with AD who may qualify for the study's comparison groups. Participation is voluntary, and information collected through the study is kept confidential.¹

"Every participant who shares their experience helps expand the evidence available to support informed eczema treatment decisions during pregnancy," Chambers said. "Our goal is to provide reliable, science-based information that benefits patients, healthcare providers, and future families."¹

Every participant who shares their experience helps expand the evidence available to support informed eczema treatment decisions during pregnancy, — Christina D. Chambers, PhD, MPH

For dermatology clinicians managing patients with moderate-to-severe AD during pregnancy, the registry provides an opportunity to contribute to the evidence base surrounding treatment decisions in a population for whom prospective clinical data remain limited. Findings from the study may ultimately provide additional evidence to inform risk-benefit discussions surrounding AD treatment during pregnancy.

References

1. New MotherToBaby study targets pregnancy data gap for newer eczema treatment. Press release. MotherToBaby. August 13, 2026. Accessed August 18, 2026. https://mothertobaby.org/ongoing-study/ebglyss-lebrikizumab-lbkz/
2. FDA approves Lilly's EBGLYSS (lebrikizumab-lbkz) for adults and children 12 years and older with moderate-to-severe atopic dermatitis. Press release. Eli Lilly and Company. September 13, 2024. Accessed August 18, 2026. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglyssr-lebrikizumab-lbkz-one-maintenance
3. EBGLYSS (lebrikizumab-lbkz) injection, for subcutaneous use. Prescribing information. Eli Lilly and Company; 2024. Accessed August 18, 2026. https://www.molinamarketplace.com/marketplace/il/en-us/Providers/-/media/4317266790194BCBA0560D4069DE4329.ashx