Calendario›REGN›dupilumab
dupilumab
Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy
Ensayo de REGENERON PHARMACEUTICALS, INC. en Atopic Dermatitis (AD) · Asthma (del registro, en inglés).
Más ensayos de: Asma.
- Fase
- no aplica
- Estado
- Completado
- Participantes
- 581
- Centros
- 1
- Fin del objetivo primario
- nov 2025
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio observacional. Comenzó en oct 2018.
Qué mide
Rate of major structural defects (Up to 1 Year of Age) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe objective is to evaluate the potential effect of exposure to dupilumab in pregnancy compared to the primary comparison group of disease-matched pregnant women who are not exposed to dupilumab, and the secondary comparison group of healthy pregnant women. The primary outcome of the study is major structural defects, and the secondary outcomes of the study are spontaneous abortion/miscarriage, stillbirth, elective termination/abortion, premature delivery, small for gestational age, pattern of 3 or more minor structural defects, postnatal growth of live born children to 1 year of age, postnatal serious or opportunistic infections in live born children to 1 year of age, and hospitalizations in live children up to 1 year of age.
Más ensayos de REGN
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| cemiplimab | Fase 2 | En marcha, sin reclutar | mar 2025 (real) |
| Pozelimab + Cemdisiran · NIMBLE | Fase 3 | En marcha, sin reclutar | jul 2025 (real) |
| Garetosmab · OPTIMA | Fase 3 | En marcha, sin reclutar | jul 2025 (real) |
| Aflibercept 8 mg · ELARA | Fase 3 | En marcha, sin reclutar | ago 2025 (real) |
| Dupilumab · ENGAGE | Fase 2 | En marcha, sin reclutar | feb 2026 (real) |
| Fianlimab | Fase 3 | En marcha, sin reclutar | mar 2026 (real) |
Todos los de REGN, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04173442), actualizada en mar 2026.