Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab

NCT03992729 | Recruiting

• 1 other identifier: TILD 3357-2
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Major structural defects in children

  defined and classified using the US Centers for Disease Control and Prevention (CDC) coding manual that is used for the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of major structural defects

  Up to 1 year of age

Secondary Outcomes (9)

• Spontaneous abortion/miscarriage

  20 weeks post-last menstrual period

• Stillbirth

  from 20 weeks post-last menstrual period to end of pregnancy

• Elective termination/abortion

  At the end of pregnancy or through 9 month pregnancy period

• neonatal/infant death

  6 months of age

• Small for gestational age

  at birth

Study Arms (2)

Tildrakizumab-Exposed Cohort

Exposure to tildrakizumab for the treatment of an approved indication

Drug: Pregnant women exposed to tildrakizumab

Disease-Matched Comparison Cohort

No exposure to tildrakizumab at any time in the current pregnancy

Drug: Pregnant women not exposed to tildrakizumab

Interventions

Pregnant women exposed to tildrakizumab DRUG

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

Tildrakizumab-Exposed Cohort

Pregnant women not exposed to tildrakizumab DRUG

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

Disease-Matched Comparison Cohort

Eligibility Criteria

• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women diagnosed with tildrakizumab-approved indication with and without tildrakizumab

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (1)

Christina Chambers

San Diego, California, 92093, United States

RECRUITING

Central Study Contacts

Head, Clinical Development

CONTACT

91 2266455645; Clinical.Trial@sunpharma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 20, 2019
• Study Start: August 29, 2019
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (1)