nctId: NCT06315738 id: ST266-NEC-201 briefTitle: Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis overallStatus: RECRUITING date: 2024-03-29 date: 2026-12 date: 2027-08 date: 2024-03-18 date: 2024-04-02 name: Noveome Biotherapeutics, formerly Stemnion class: INDUSTRY name: Parexel briefSummary: The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC by incidence of treatment emergent adverse events (TEAEs) and SAEs, with a secondary objective to assess preliminary efficacy of the same two dose levels (0.5 mL/kg and 1.0 mL/kg) of QD via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC. conditions: Necrotizing Enterocolitis studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: ST266 measure: Safety and Tolerability endpoint: incidence of adverse events measure: Safety and Tolerability endpoint: incidence of serious adverse events measure: Safety and Tolerability endpoint: Changes in labs and vitals relative to disease progression measure: Efficacy endpoint: Time to pneumatosis resolution measure: Efficacy endpoint: Time to full enteral nutrition assessment measure: Efficacy endpoint: Incidence of abdominal surgical intervention measure: Efficacy endpoint: Change in Neonatal Sequential Organ Failure Assessment (nSOFA) score measure: Exploratory endpoint: All cause mortality measure: Exploratory endpoint: Length of stay in the NICU measure: Exploratory endpoint: Change in weight over time measure: Exploratory endpoint: Change in length over time measure: Exploratory endpoint: Change in head circumference over time measure: Exploratory endpoint: Number of significant apnea events/day over time measure: Exploratory endpoint: Number of significant bradycardia events/day over time measure: Exploratory endpoint: Number of significant temperature instability events/day over time measure: Exploratory endpoint: Time to return to normal bowel sounds measure: Exploratory endpoint: Change in serum C-reactive protein (CRP) measure: Exploratory endpoint: Time to return to normal serum platelet count levels measure: Exploratory endpoint: Incidence of intestinal or colonic strictures measure: Exploratory endpoint: Incidence of sepsis measure: Exploratory endpoint: Incidence of retinopathy measure: Exploratory endpoint: Incidence of bronchopulmonary dysplasia (BPD) measure: Exploratory endpoint: Incidence of pulmonary hypertension (PH) measure: Exploratory endpoint: Incidence of periventricular leukomalacia sex: ALL minimumAge: 2 Weeks maximumAge: 8 Weeks stdAges: CHILD facility: BayCare Health System-St. Joseph's Women's Hospital status: RECRUITING city: Tampa state: Florida zip: 33607 country: United States name: Jenelle Ferry, MD role: CONTACT phone: 813-872-2924 email: jenelle.ferry@baycare.org name: Jenelle Ferry, MD role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False