NCT07017699 · Bristol-Myers Squibb
A Study to Assess Deucravacitinib Safety in Pregnancy
What this study is about
The purpose of this study is to assess pregnancy and infant outcomes among pregnant participants enrolled in an established North American pregnancy registry (Organization of Teratology Information Specialists \[OTIS\]) who were exposed to deucravacitinib.
View original scientific description
The purpose of this study is to assess pregnancy and infant outcomes among pregnant participants enrolled in an established North American pregnancy registry (Organization of Teratology Information Specialists \[OTIS\]) who were exposed to deucravacitinib.
Interventions
DRUG
Deucravacitinib
According to product label
DRUG
Other systemic treatments for PsO
According to product label
Primary outcome measures
Number of major congenital malformations among infants
Time frame: 1-year post pregnancy outcome
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: Deucravacitinib-exposed cohort
- Currently pregnant during the enrollment period
- Diagnosed with psoriasis (PsO) validated by medical records when possible
- Exposure to deucravacitinib for any number of days, at any dose, and at any time from 2 days prior to date of conception (DOC) to the end of pregnancy
- Agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the dysmorphology examination of live born infants Cohort 2: PsO Disease-matched unexposed comparator cohort
- Currently pregnant during the enrollment period
- Diagnosed with PsO validated by medical records when possible
- May be exposed to systemic treatments for PsO
- Agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the dysmorphology examination of live born infants Cohort 3: Non-disease unexposed comparator cohort
- Currently pregnant during the enrollment period
- Agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the dysmorphology examination of live born infants
Exclusion criteria
- Cohort 1: Deucravacitinib-exposed cohort
- Pregnant women who have enrolled in this cohort study with a previous pregnancy
- Pregnant women who have used deucravacitinib for an indication other than PsO
- Women who do not have exposure to deucravacitinib anytime from 2 days prior to DOC to the end of pregnancy
- Women who have exposure to another oral tyrosine kinase 2 (TYK2) inhibitor or any oral Janus kinase (JAK) inhibitor from within 5 half-lives of DOC to the end of pregnancy
- Women who have exposure to methotrexate or an oral retinoid
- Retrospective enrollment after the outcome of pregnancy is known (ie, the pregnancy has ended prior to enrollment)
- Results of a diagnostic test are positive for an major congenital malformation(s) (MCM) prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate an MCM Cohort 2: Disease-matched unexposed comparator cohort
- Pregnant women who have enrolled in this cohort study with a previous pregnancy
- Women who have exposure to deucravacitinib or any other oral TYK2 inhibitor except deucravacitinib, or any oral JAK inhibitor from within 5 half-lives of DOC to the end of pregnancy
- Women who have exposure to methotrexate or an oral retinoid
- Retrospective enrollment after the outcome of pregnancy is known (ie, the pregnancy has ended prior to enrollment)
- Results of a diagnostic test are positive for an MCM prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate an MCM Cohort 3: Non-disease unexposed comparator cohort
- Pregnant women who have enrolled in this cohort study with a previous pregnancy
- Women who have had exposure to deucravacitinib or any other oral TYK2 inhibitor, or any oral JAK inhibitor from within 5 half-lives of DOC to the end of pregnancy
- Retrospective enrollment after the outcome of pregnancy is known (ie, the pregnancy has ended prior to enrollment)
- Results of a diagnostic test are positive for an MCM prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate an MCM
- Women exposed to a known, possible, or suspected human teratogen during pregnancy as confirmed by the OTIS Research Center (see Appendix 3 for list of known, possible, and suspected human teratogens)
- Women who are diagnosed with PsO, or any other autoimmune disease
Where
- La Jolla, California
Related conditions & keywords
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 Jun 12, 2025 · Source of record for eligibility and locations