Plain-English translation of NCT06659029 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
PRIMULA Preg is a pregnancy registry designed to track the safety of , a medication used to treat moderate to severe lupus, in pregnant people and their babies. Researchers will compare pregnancy outcomes between people who use this medication during pregnancy and those who use other lupus treatments instead. The study will help doctors understand whether the medication is safe to use while pregnant.
There is limited information about how this medication affects pregnant people and developing babies. This registry will help fill that gap by collecting real-world pregnancy outcomes, which will help the FDA and healthcare providers make informed decisions about whether this treatment is appropriate for pregnant patients with lupus.
You likely qualify if…
You likely don't qualify if…
This is an observational study, meaning you don't need to do anything extra beyond your normal medical care. Researchers will collect information from your medical records before, during, and after your pregnancy. You will not need to attend additional appointments or undergo extra tests — your doctor will continue managing your care as usual, and the registry will simply gather the data your healthcare team already documents.
AI-generated summary from trial data · Jun 25, 2026 · Not medical advice
United States
Sponsor
AstraZeneca
Collaborators
PPD Development, LP
Enrollment target
~442 participants
Started
July 2025
Primary completion
April 2031
Sex
Female only
Last updated on clinicaltrials.gov in June 2026.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
AstraZeneca Clinical Study Information Center
AstraZeneca
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.