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New study monitors psoriasis drug safety in pregnant women

NCT ID NCT03992729

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2019

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Christina Chambers

    RECRUITING

    San Diego, California, 92093, United States

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Other studies related to the condition(s) this trial covers.