La Jolla, CANCT05938478Now EnrollingIRB Ready

Atopic Dermatitis Clinical Trial in La Jolla, CA

Access cutting-edge atopic dermatitis treatment through this clinical trial at a research site in La Jolla. Study-provided care at no cost to qualified participants.

Sponsored by University of California, San Diego

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Expert Care in La Jolla

Access atopic dermatitis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related atopic dermatitis treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to La Jolla

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit La Jolla site if eligible
  4. 4Begin participation

About This Atopic Dermatitis Study in La Jolla

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.

Sponsor: University of California, San Diego

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in La Jolla?

Yes, this clinical trial (NCT05938478) has an active research site in La Jolla, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Atopic Dermatitis Treatment Options in La Jolla, CA

If you're searching for atopic dermatitis treatment options in La Jolla, CA, this clinical trial (NCT05938478) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our La Jolla research site is actively enrolling participants for this clinical trial. You'll receive care from experienced atopic dermatitis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all atopic dermatitis clinical trials near you to find additional studies recruiting in your area.

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