Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT

Overview

The goal of this observational study is to learn about exposure to tralokinumab during pregnancy, as well as atopic dermatitis (AD) during pregnancy. The main question the study aims to answer is whether pregnant people who have been exposed to tralokinumab during pregnancy experience any differences in pregnancy and infant outcomes compared to women with atopic dermatitis who have not been exposed to tralokinumab during pregnancy. Participants are not required to take tralokinumab during the study. Participants will be asked to: * Complete 1-3 phone interviews during pregnancy and 1-2 phone interviews after delivery * Release medical records for pregnancy and for their child * Complete an online survey about their baby's development at 4 months and 12 months of age * May be asked to have a study doctor examine their child All information is collected remotely, and no visits to the study site are required.

Detailed description

This Organization of Teratology Information Specialists (OTIS) Pregnancy Registry, is a United States (US) based registry designed to monitor pregnancy and infant outcomes among women in the US and Canada. This study is a prospective, observational cohort study of pregnancy and infant outcomes in pregnant people with exposure to tralokinumab for atopic dermatitis compared to people who have atopic dermatitis who have not used tralokinumab during pregnancy.

Researchers will compare pregnancy outcomes of those who were exposed to tralokinumab during pregnancy to pregnancy outcomes in people who did not use tralokinumab anytime in pregnancy, or 16 weeks prior to pregnancy, but who may or may not have used another medication to treat their atopic dermatitis during pregnancy. Information about infant health will be collected through one year of age.

Interventions

• Drug Tralokinumab
  This is a prospective observational cohort study. There is no treatment allocation. Participants that have been exposed to tralokinumab before enrollment into the study will be enrolled.

Primary outcome measures

• Prevalence of Major Structural Birth Defects [Time frame: Up to 1-year of age]

Secondary outcome measures (10)

• Number of pregnancies ending in Spontaneous Abortion/Miscarriage [Time frame: Up to 20 weeks post-LMP]
• Number of pregnancies ending in Stillbirth [Time frame: From 20 weeks post-LMP to end of pregnancy]
• Number of pregnancies ending in Elective Termination/Abortion [Time frame: At the completion of pregnancy; before 40 weeks post-LMP]
• Number of pregnancies ending in Premature Delivery [Time frame: Through 9 months of pregnancy]
• A Pattern of Minor Structural Birth Defects [Time frame: Through completion of the study; an average of 1 year]
• Number of children who are Small for Gestational Age [Time frame: At birth]
• Number of children who are Small for Age for Postnatal Growth [Time frame: Up to 1 year of age]
• Number of children diagnosed with a Serious or Opportunistic Infections [Time frame: Up to 1 year of age]
• Screening for Neurodevelopmental Milestones [Time frame: 4 months and 12 months of age]
• Number of Perinatal, Neonatal, or Infant Deaths [Time frame: From 20 weeks gestation to 12 months of age]

Eligibility criteria

Inclusion criteria

Eligibility for the cohort study includes the following:

• Currently pregnant at the time of enrollment
• Reside in the US or Canada at the time of enrollment
• Verbal informed consent to participate OTIS Pregnancy Registry
• Current diagnosis of AD at the time of enrollment

Cohort 1: Tralokinumab-Exposed Cohort

• Diagnosed with AD
• Exposure to tralokinumab for any number of days, at any dose, and at any time during pregnancy or within 16 weeks prior to the date of conception
• Agree to the conditions and requirements of the study including the interview schedule, dysmorphology exam (for the first 80 pregnancies resulting in live born infants), developmental screening, and release of medical records

Cohort 2: AD Comparator I- Phototherapy or Systemic Treatment

• Diagnosed with AD
• Exposed to phototherapy and/or systemic therapy for the treatment of AD for any number of days, at any dose, and at any time within 5 half-lives prior to the date of conception or during pregnancy
• Agree to the conditions and requirements of the study including the interview schedule, dysmorphology exam (for the first 80 pregnancies resulting in live born infants), developmental screening, and release of medical records

Cohort 3: AD Comparator II - With or Without Treatment

• Diagnosed with AD
• May or may not have received treatment for AD, but have not been exposed to any dose of phototherapy or systemic therapy for the treatment of AD within 5 half-lives prior to the estimated date of conception or any time during pregnancy.
• Agree to the conditions and requirements of the study including the interview schedule, dysmorphology exam (for the first 80 pregnancies resulting in live born infants), developmental screening, and release of medical records

Exclusion criteria

Pregnant women meeting any of the following criteria will not be included in the cohort study:

Cohort 1: Tralokinumab-Exposed Cohort

• Women who have enrolled in the tralokinumab cohort study with a previous pregnancy
• Exposure to any dose of methotrexate or mycophenolate mofetil within 5 half-lives prior to the estimated date of conception or anytime during pregnancy
• Retrospective enrollment after the outcome of pregnancy is known (i.e., the pregnancy has ended prior to enrollment)
• Results of a diagnostic test are positive for a major structural birth defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect

Cohort 2: AD Therapy Comparator I- Phototherapy or Systemic Treatment

• Pregnant women who have enrolled in the tralokinumab cohort study with a previous pregnancy
• Exposure to any dose of tralokinumab, methotrexate or mycophenolate mofetil within 5 half-lives prior to the estimated date of conception or anytime during pregnancy.
• Retrospective enrollment after the outcome of pregnancy is known (i.e., the pregnancy has ended prior to enrollment)
• Results of a diagnostic test are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect

Cohort 3: AD Therapy Comparator II - With or Without Treatment

• Pregnant women who have enrolled in the tralokinumab cohort study with a previous pregnancy
• Exposure to any dose of tralokinumab, methotrexate or mycophenolate mofetil within 5 half-lives prior to the estimated date of conception or anytime during pregnancy
• Exposure to any dose of phototherapy and/or systemic therapy for the treatment of AD within 5 half-lives prior to the estimated date of conception or during pregnancy
• Retrospective enrollment after the outcome of pregnancy is known (i.e., the pregnancy has ended prior to enrollment)
• Results of a diagnostic test are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect

Case-Series: Tralokinumab-Exposed Case Series

Pregnancies with tralokinumab exposure that do not meet the exposed cohort (Cohort 1) criteria will be excluded from the cohort, but will be included in the Exposure Series. Women who are eligible for enrollment in the Exposure Series include, but are not limited to the following: exposed to tralokinumab during pregnancy for an indication other than AD, women who enrolled with a previous pregnancy in the cohort, and retrospective reports of a tralokinumab-exposed pregnancy after the outcome of pregnancy is known. With informed consent, data will be collected from those enrolled in the Exposure Series from maternal interviews and medical record review using the same protocol as the cohort study to the extent possible.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• University of California San Diego (UCSD) — La Jolla

Identifiers

NCT: NCT05938478 · NIS-TRALO-2235

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗