Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT
NCT ID: NCT05938478
Last Updated: 2025-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
900 participants
OBSERVATIONAL
2022-12-08
2035-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Tralokinumab-Exposed Cohort
Pregnant women with AD exposed to tralokinumab anytime during pregnancy, or within 16 weeks before conception
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.
AD Cohort- Phototherapy or Systemic Treatment Exposed
Pregnant women with AD who have not been exposed to tralokinumab, but who have been exposed to phototherapy or systemic therapy for the treatment of AD during pregnancy
No interventions assigned to this group
AD Cohort - With or Without Treatment
Pregnant women with AD who may or may not have received treatment for AD, but who have not been exposed to any dose of tralokinumab, phototherapy or systemic therapy during pregnancy
No interventions assigned to this group
Tralokinumab-Exposed Case Series
Pregnant women with AD exposed to tralokinumab anytime during pregnancy, or within 16 weeks before conception, who don't meet the eligibility criteria for the tralokinumab-exposed cohort group
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
FEMALE
No
Sponsors
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LEO Pharma
INDUSTRY
The Organization of Teratology Information Specialists
OTHER
University of California, San Diego
OTHER
Responsible Party
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Christina Chambers
Principal Investigator, Professor, Chief of the Division of Environmental Science and Health
Locations
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University of California San Diego (UCSD)
La Jolla, California, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Study website page
Other Identifiers
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NIS-TRALO-2235
Identifier Type: -
Identifier Source: org_study_id
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