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

Conditions

• Necrotizing Enterocolitis

Eligibility Criteria

Sex

ALL

Age

2 Weeks - 8 Weeks

Healthy Volunteers

Not accepted

Interventions

• ST266 — BIOLOGICAL
  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.

Study Details

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.

Key Dates

Start date

Aug 19, 2024

Status verified

Apr 2026

Primary completion

Jun 30, 2029

Completion

Nov 30, 2029

Study Design

Enrollment

36 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Other: Cohort 1 - lower dose active + SOC treatment vs. SOC alone in higher weight range
  Infants with weight at diagnosis of NEC ≥1000 g and ≤3000 g; 0.5 mL/kg of ST266, QD, + Standard of Care (SOC) treatment (n=6); SOC (n=3)
• Other: Cohort 2 - higher dose active + SOC treatment vs. SOC alone in higher weight range
  Infants with weight at diagnosis of NEC ≥1000 g and ≤3000 g; 1.0 mL/kg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)
• Other: Cohort 3 - lower dose active + SOC treatment vs. SOC alone in lower weight range
  Infants with weight at diagnosis of NEC ≥500 g and ≤999 g; 0.5 mL/kg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)
• Other: Cohort 4 - higher dose active + SOC treatment vs. SOC alone in lower weight range
  Infants with weight at diagnosis of NEC ≥500 g and ≤999 g; 1.0 mL/kg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)

Primary Outcome Measure

Safety and Tolerability endpoint: incidence of adverse events [ Time Frame: From date of randomization through 24 months of age ]

Central Contacts

• Karin Potoka, MD
  412-512-1446
  [email protected]
• Shawna M Rose, BS
  513-205-1091
  [email protected]

Locations (8)

Find similar trials in Little Rock, AR

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