NCT03992729 · Sun Pharmaceutical Industries Limited
Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
What this study is about
This study will utilize a forward-looking, observational, exposure group of participants design to examine pregnancy and infant outcomes in women and infants who are exposed to tildrakizumab during pregnancy to treat an approved indication.
View original scientific description
This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to tildrakizumab during pregnancy to treat an approved indication. The pregnancy registry cohort study will be conducted by the Organization of Teratology Information Specialists (OTIS), which is a network of university and health department based information centers serving pregnant women and healthcare providers throughout North America. These services provide a basis for collaborative research such as this Registry. These Services located throughout the United States (US) and Canada will serve as a source of referrals not only for tildrakizumab-exposed pregnancies but also for similarly ascertained disease-matched comparison pregnant women who have not used tildrakizumab in pregnancy. The target follow-up period will be until end of pregnancy and 1 year of age for live born infants.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Cohort 1: Tildrakizumab-Exposed Cohort
- Pregnant women
- 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
- Agree to the conditions and requirements of the study including the interview schedule, and release of medical records Cohort 2: Disease-Matched Comparison Cohort
- Pregnant women
- Diagnosed with a tildrakizumab-approved indication; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible
- 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
- 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:
- Women who have first contact with the project after prenatal diagnosis of any major structural defect
- Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
- Women who have used tildrakizumab for an indication other than a currently approved indication
- Retrospective enrollment after the outcome of pregnancy is known Cohort 2: Disease-Matched Comparison Cohort
- Women who have first contact with the project after prenatal diagnosis of any major structural defect
- Exposure to tildrakizumab anytime during the current pregnancy
- Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
- Retrospective enrollment after the outcome of pregnancy is known
Exclusion criteria
- Cohort 1: Tildrakizumab-Exposed Cohort:
- Women who have first contact with the project after prenatal diagnosis of any major structural defect
- Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
- Women who have used tildrakizumab for an indication other than a currently approved indication
- Retrospective enrollment after the outcome of pregnancy is known Cohort 2: Disease-Matched Comparison Cohort
- Women who have first contact with the project after prenatal diagnosis of any major structural defect
- Exposure to tildrakizumab anytime during the current pregnancy
- Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
- Retrospective enrollment after the outcome of pregnancy is known
Where
- San Diego, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 21, 2026 · Source of record for eligibility and locations