Recruiting

Tildrakizumab

Sponsor:

Sun Pharmaceutical Industries Limited

Code:

NCT03992729

Conditions

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Pregnant women exposed to tildrakizumab

Pregnant women not exposed to tildrakizumab

Study Details

Brief summary:

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.

Conditions

Pregnancy Related

Study ID

NCT03992729

Start date

Aug 29, 2019

Status verified date

Jan, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Tildrakizumab-Exposed Cohort

Exposure to tildrakizumab for the treatment of an approved indication

Disease-Matched Comparison Cohort

No exposure to tildrakizumab at any time in the current pregnancy

Interventions

Pregnant women exposed to tildrakizumab

Subjects 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 (LMP) up to and including the end of pregnancy

Pregnant women not exposed to tildrakizumab

Subjects diagnosed with a tildrakizumab-approved indication; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible, and Subjects with 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

Primary outcome measure

  • Major structural defects in children [ Time Frame: Up to 1 year of age ]

Central Contacts and Locations

Central contacts

Head, Clinical Development

91 2266455645Clinical.Trial@sunpharma.com

Locations

Christina Chambers

Recruiting

San Diego, California, United States, 92093

More Information

Sponsor

Sun Pharmaceutical Industries Limited

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sun Pharmaceutical Industries Limited on 2026-01-21.