New study monitors psoriasis drug safety in pregnant women
NCT ID NCT03992729
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 200 pregnant women who take tildrakizumab for conditions like psoriasis, along with a similar group who don't take the drug. Researchers track pregnancy outcomes and infant health up to one year after birth to check for birth defects or other problems. The goal is to gather safety information, not to test a new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2019
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Pregnant women diagnosed with tildrakizumab-approved indication with and without tildrakizumab
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Cohort 1: Tildrakizumab-Exposed Cohort 1. Pregnant women 2. Exposure to tildrakizumab for the treatment of an approved indication, for any number of days, at any dose, and at any time from the first day of the last menstrual period up to and including the end of pregnancy 3. Agree to the conditions and requirements of the study including the interview schedule, and release of medical records Cohort 2: Disease-Matched Comparison Cohort 1. Pregnant women 2. Diagnosed with a tildrakizumab-approved indication; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible 3. No exposure to tildrakizumab at any time in the current pregnancy; may or may not have taken another medication for their disease in the current pregnancy 4. Agree to the conditions and requirements of the study including the interview schedule, and release of medical records Exclusion criteria: Cohort 1: Tildrakizumab-Exposed Cohort: 1. Women who have first contact with the project after prenatal diagnosis of any major structural defect 2. Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study) 3. Women who have used tildrakizumab for an indication other than a currently approved indication 4. Retrospective enrollment after the outcome of pregnancy is known Cohort 2: Disease-Matched Comparison Cohort 1. Women who have first contact with the project after prenatal diagnosis of any major structural defect 2. Exposure to tildrakizumab anytime during the current pregnancy 3. Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study) 4. Retrospective enrollment after the outcome of pregnancy is known
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Christina Chambers
RECRUITINGSan Diego, California, 92093, United States
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