Phase 4 Lupus Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For the mother:

• The mother is 18 years of age or older
• The mother has given signed consent to take part in the study
• The mother has been diagnosed with moderate or severe lupus (SLE)
• The mother is currently being treated with a medicine called anifrolumab
• The mother has been receiving anifrolumab long enough for the medicine to reach a stable level in the body by the first study visit (around 85 days after giving birth, after at least 3 intravenous doses or 12 under-the-skin doses)
• The mother has been breastfeeding or pumping breast milk for at least 4 weeks by the first study visit
• The mother is willing to breastfeed or pump regularly throughout the study, and to pump exclusively for a 24-hour period on the first study day
• The mother plans to continue feeding her baby breast milk for the full length of the study and is not in the process of stopping breastfeeding
• The mother is either exclusively feeding her baby breast milk, or giving no more than one bottle of formula per day, at the time of joining and throughout the study
• The mother agrees to use only lanolin nipple cream during the milk collection period

For the baby:

• The baby was born at 32 weeks of pregnancy or later
• The baby's birth weight was above the 10th percentile for their age (not among the lowest 10% of birth weights)
• The baby's weight at the time of joining the study is above the 10th percentile for their age

Who may not be able to join:

For the mother:

• The mother has taken another experimental treatment, or an approved biologic or similar medicine, within the past 30 days or within 5 half-lives of that medicine, whichever is the longer period
• The mother has been diagnosed with lupus affecting the kidneys (lupus nephritis) in the past 12 months
• The mother has a history of breast implants, breast enlargement, or breast reduction surgery that significantly affects breastfeeding or the ability to collect milk from one or both breasts
• The mother has had a cancer diagnosis in the past 10 years
• The mother has had a breast removal (mastectomy)
• The mother shows signs of a breast infection (mastitis) or any other significant active infection at the first study visit

For the baby:

• The baby has any notable health condition — including heart, lung, or liver problems, unstable blood sugar, or an active infection — that the study doctor believes could make it difficult to carry out the study safely or could put the baby at risk by participating (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.