Clinical trial NCT05938478: Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT
Official title: Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Eczema
Keywords: AD
Eczema
Atopic dermatitis
Tralokinumab
Adbry
Adtralza
Pregnancy
Infant
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: LEO Pharma
name: The Organization of Teratology Information Specialists
First posted: 2023-07-10
Enrollment: 900
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes pregnant women who reside in the US or Canada.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

Eligibility for the cohort study includes the following:

1. Currently pregnant at the time of enrollment
2. Reside in the US or Canada at the time of enrollment
3. Verbal informed consent to participate OTIS Pregnancy Registry
4. Current diagnosis of AD at the time of enrollment

Cohort 1: Tralokinumab-Exposed Cohort

1. Diagnosed with AD
2. 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
3. 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

1. Diagnosed with AD
2. 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
3. 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

1. Diagnosed with AD
2. 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.
3. 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

1. Women who have enrolled in the tralokinumab cohort study with a previous pregnancy
2. Exposure to any dose of methotrexate or mycophenolate mofetil within 5 half-lives prior to the estimated date of conception or anytime during pregnancy
3. Retrospective enrollment after the outcome of pregnancy is known (i.e., the pregnancy has ended prior to enrollment)
4. 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

1. Pregnant women who have enrolled in the tralokinumab cohort study with a previous pregnancy
2. 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.
3. Retrospective enrollment after the outcome of pregnancy is known (i.e., the pregnancy has ended prior to enrollment)
4. 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

1. Pregnant women who have enrolled in the tralokinumab cohort study with a previous pregnancy
2. 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
3. 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
4. Retrospective enrollment after the outcome of pregnancy is known (i.e., the pregnancy has ended prior to enrollment)
5. 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.

Primary outcomes:
measure: Prevalence of Major Structural Birth Defects
timeFrame: Up to 1-year of age
Secondary outcomes:
measure: Number of pregnancies ending in Spontaneous Abortion/Miscarriage
timeFrame: Up to 20 weeks post-LMP
measure: Number of pregnancies ending in Stillbirth
timeFrame: From 20 weeks post-LMP to end of pregnancy
measure: Number of pregnancies ending in Elective Termination/Abortion
timeFrame: At the completion of pregnancy; before 40 weeks post-LMP
measure: Number of pregnancies ending in Premature Delivery
timeFrame: Through 9 months of pregnancy
measure: A Pattern of Minor Structural Birth Defects
timeFrame: Through completion of the study; an average of 1 year
measure: Number of children who are Small for Gestational Age
timeFrame: At birth
measure: Number of children who are Small for Age for Postnatal Growth
timeFrame: Up to 1 year of age
measure: Number of children diagnosed with a Serious or Opportunistic Infections
timeFrame: Up to 1 year of age
measure: Screening for Neurodevelopmental Milestones
timeFrame: 4 months and 12 months of age
measure: Number of Perinatal, Neonatal, or Infant Deaths
timeFrame: From 20 weeks gestation to 12 months of age
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego (UCSD)
state: California
Study officials:
References: