NCT07017699招募中不适用
The Deucravacitinib Pregnancy Exposure Study: A Prospective Observational Study of Deucravacitinib Safety in Pregnancy
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2025年3月21日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Number of major congenital malformations among infants
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Deucravacitinib Cohort
Pregnant participants with psoriasis exposed to deucravacitinib treatment
干预措施: Deucravacitinib (Drug)
Other Systemic Treatment Cohort
Pregnant participants with psoriasis exposed to other systemic treatments for PsO
干预措施: Other systemic treatments for PsO (Drug)
结局指标
主要结局
Number of major congenital malformations among infants
时间窗: 1-year post pregnancy outcome
次要结局
- Number of other pregnancy and infant outcomes(1-year post pregnancy outcome)
研究者
研究点 (1)
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