Atopic DermatitisPROTECTNCT05938478
Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT
An observational study of Atopic Dermatitis and Eczema, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Atopic Dermatitis, Eczema
- What is being tested?
- Tralokinumab
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2022to 30 Sep 2035
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes pregnant women who reside in the US or Canada.
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Diego (UCSD)
La Jolla, California, 92093
Diana Johnson, MS, 877-311-8972, mothertobaby@health.ucsd.edu
Christina Chambers, PhD, MPH
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Atopic Dermatitis, Eczema
- Being tested
- Tralokinumab
- Keywords
- AD, Eczema, Atopic dermatitis, Tralokinumab, Adbry, Adtralza, Pregnancy, Infant
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TralokinumabDrug
Also called Adbry, Adtralza
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.
| Study group | Role | What they receive |
|---|---|---|
| Tralokinumab-Exposed Cohort | Pregnant women with AD exposed to tralokinumab anytime during pregnancy, or within 16 weeks before conception Receives: 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 Receives: Drug: Tralokinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1-year of age
Secondary outcomes (10)
Number of pregnancies ending in Spontaneous Abortion/Miscarriage
Spontaneous abortion/miscarriage is defined as non-deliberate fetal death that occurs prior to 20 weeks after the first day of the last menstrual period (LMP).
Measured: Up to 20 weeks post-LMP
Number of pregnancies ending in Stillbirth
Stillbirth is defined as non-deliberate fetal death anytime in gestation at or after 20 weeks after the first day of the last menstrual period (LMP).
Measured: From 20 weeks post-LMP to end of pregnancy
Number of pregnancies ending in Elective Termination/Abortion
Elective termination/abortion is defined as deliberate termination of pregnancy through medication or surgical procedures. Elective abortions are classified for medical or social reasons.
Measured: At the completion of pregnancy; before 40 weeks post-LMP
Number of pregnancies ending in Premature Delivery
Premature delivery is defined as live birth prior to 37 weeks gestation as counted from LMP (or calculated from first-trimester ultrasound-derived due date if LMP uncertain or more than 1 week discrepant).
Measured: Through 9 months of pregnancy
A Pattern of Minor Structural Birth Defects
A pattern of 3 or more minor structural defects occurring in at least two children in any of the cohorts and identified by a study examiner based on the study-related physical examination.
Measured: Through completion of the study; an average of 1 year
Number of children who are Small for Gestational Age
Small for gestational age is defined as birth size (weight, length or head circumference) less than the 10th centile for sex and gestational age using standard pediatric CDC growth curves for full term or preterm infants.
Measured: At birth
Number of children who are Small for Age for Postnatal Growth
Small for age for postnatal growth is defined as postnatal size (weight, length or head circumference) less than the 10th centile for sex and age using National Center for Health Statistics (NCHS) pediatric growth curves, and adjusted postnatal age for premature infants if the postnatal measurement is obtained at less than 1 year of age.
Measured: Up to 1 year of age
Number of children diagnosed with a Serious or Opportunistic Infections
A diagnosis of tuberculosis, x-ray proven pneumonia, neonatal sepsis, meningitis, bacteremia, invasive fungal infection, pneumocystitis, septic arthritis, osteomyelitis, abscess (deep tissue), and infections requiring hospitalization identified in live born infants
Measured: Up to 1 year of age
Screening for Neurodevelopmental Milestones
Screening for neurodevelopment performed using the Ages and Stages Questionnaire (ASQ). An abnormal score is defined in the scoring guidelines. Abnormal scores of clinical concern are defined by test-based, standardized scoring criteria reported in the ASQ-3 User's Guide. These represent scores that are less than two standard deviations below the mean for each category. Borderline scores are scores that fall between 2.0 and 1.5 standard deviations below the mean. The ASQ-3 does not provide a borderline score range but they suggest that children be monitored when they have scores 1.0 - 2.0 standard deviations below the mean.
Measured: 4 months and 12 months of age
Number of Perinatal, Neonatal, or Infant Deaths
Stillbirth is defined as non-deliberate fetal death anytime in gestation at or after 20 weeks after the first day of the last menstrual period (LMP). Neonatal death is defined as death of live born infant within 28 days of delivery. Infant death is defined as death of a live born infant >28 days old to 1 year of life.
Measured: From 20 weeks gestation to 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start8 Dec 2022
- Primary completion30 Nov 2034 (estimated)
- Study completion30 Sep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma, The Organization of Teratology Information Specialists
- Responsible party
- Principal investigator, Christina Chambers, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938478
- Sponsor's protocol ID
- NIS-TRALO-2235
- Acronym
- PROTECT
- Status last verified
- Jan 2025
- First submitted
- 22 May 2023
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT
- ClinicalTrials.gov ID
- NCT05938478
- Acronym / sponsor ID
- PROTECT / NIS-TRALO-2235
- Conditions
- Atopic Dermatitis, Eczema
- Keywords
- AD, Eczema, Atopic dermatitis, Tralokinumab, Adbry, Adtralza, Pregnancy, Infant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- LEO Pharma, The Organization of Teratology Information Specialists
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 30 Nov 2034 (estimated)
- Study completion
- 30 Sep 2035 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tralokinumab-Exposed Cohort | – | Drug: TralokinumabPregnant women with AD exposed to tralokinumab anytime during pregnancy, or within 16 weeks before conception |
| 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 | – | Drug: TralokinumabPregnant 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes pregnant women who reside in the US or Canada.
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TralokinumabAlso: Adbry, AdtralzaThis 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. | Drug | Tralokinumab-Exposed Case Series, Tralokinumab-Exposed Cohort |
Primary outcome
Prevalence of Major Structural Birth Defects
Time frame: Up to 1-year of age
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Study website pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Eczema, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Johnson, MS (877-311-8972, mothertobaby@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Major Structural Birth Defects (time frame: Up to 1-year of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.