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

NCT05938478 | Recruiting FDA Drug

• 1 other identifier: NIS-TRALO-2235
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Eczema

Keywords

AD; Eczema; Atopic dermatitis; Tralokinumab; Adbry; Adtralza; Pregnancy; Infant

Outcome Measures

Primary Outcomes (1)

• Prevalence of Major Structural Birth Defects

  Major structural defects is defined and classified using the US Centers for Disease Control and Prevention (CDC) coding manual that is used for the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of major structural defects. All major structural defects will be adjudicated by the co-investigator on this study.

  Up to 1-year of age

Secondary Outcomes (10)

• Number of pregnancies ending in Spontaneous Abortion/Miscarriage

  Up to 20 weeks post-LMP

• Number of pregnancies ending in Stillbirth

  From 20 weeks post-LMP to end of pregnancy

• Number of pregnancies ending in Elective Termination/Abortion

  At the completion of pregnancy; before 40 weeks post-LMP

• Number of pregnancies ending in Premature Delivery

  Through 9 months of pregnancy

• A Pattern of Minor Structural Birth Defects

  Through completion of the study; an average of 1 year

Study Arms (4)

Tralokinumab-Exposed Cohort

Pregnant women with AD exposed to tralokinumab anytime during pregnancy, or within 16 weeks before conception

Drug: Tralokinumab

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

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

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

Drug: Tralokinumab

Interventions

Tralokinumab DRUG

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.

Also known as: Adbry, Adtralza

Tralokinumab-Exposed Case Series; Tralokinumab-Exposed Cohort

Eligibility Criteria

• Gender Eligibility Details: Pregnant people
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes pregnant women who reside in the US or Canada.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• LEO Pharma: collaborator
• The Organization of Teratology Information Specialists: collaborator

Study Sites (1)

University of California San Diego (UCSD)

La Jolla, California, 92093, United States

RECRUITING

Related Links

• Study website page

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

tralokinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Diana Johnson, MS

CONTACT

877-311-8972; mothertobaby@health.ucsd.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor, Chief of the Division of Environmental Science and Health

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: July 10, 2023
• Study Start: December 8, 2022
• Primary Completion (Estimated): November 30, 2034
• Study Completion (Estimated): September 30, 2035
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)