Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

August 19, 2024

Primary Completion Date

June 30, 2029

Study Completion Date

November 30, 2029

Conditions
Necrotizing Enterocolitis
Interventions
BIOLOGICAL

ST266

Patients randomized to investigative drug product (ST266) will receive either 0.5 mL/kg or 1.0 mL/kg of ST266 QD in addition to Standard of Care treatment; Patients randomized to SOC will receive standard of care treatment only.

Trial Locations (7)

15219

RECRUITING

University of Pittsburgh Medical Center Magee Womens Hospital, Pittsburgh

27710

ACTIVE_NOT_RECRUITING

Duke University Medical Center (DUMC), Durham

32806

ACTIVE_NOT_RECRUITING

Orlando Health, Inc. Winnie Palmer Hospital for Women and Babies, Orlando

33607

RECRUITING

BayCare Health System-St. Joseph's Women's Hospital, Tampa

60201

RECRUITING

NorthShore University-Evanston Hospital, Evanston

73104

RECRUITING

Oklahoma Children's Hospital, Oklahoma City

06510

RECRUITING

Yale-New Haven Hospital, New Haven

Sponsors
All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

Noveome Biotherapeutics, formerly Stemnion

INDUSTRY