NCT06389474

Efficacy of INM004 in Children With STEC-HUS

A Phase III Study to Evaluate the Efficacy of INM004 (Shiga Antitoxin) in Pediatric Patients With Shiga Toxin-producing Escherichia Coli-associated Hemolytic Uremic Syndrome.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Inmunova S.A. · Academic / Other
• Sex: All
• Age: 9 Months – 17 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to evaluate the efficacy, safety, and pharmacokinetics of INM004 in pediatric patients with Hemolytic Uremic Syndrome associated to infection by Shiga toxin-producing Escherichia coli (STEC-HUS).

Detailed description

The primary objective will be to evaluate the efficacy of INM004, added to the standard of care, as a treatment for STEC-HUS in the amelioration of renal function. Secondary objectives * To evaluate the efficacy of INM004 in the reduction of mortality. * To evaluate the efficacy of INM004 in the prevention and reduction of extrarenal complications. * To evaluate the efficacy of INM004 in the improvement of TMA laboratory parameters. * To evaluate the efficacy of INM004 in the reduction of hospital stay days. * To evaluate the safety of INM004 * To evaluate the pharmacokinetics of INM004 * To evaluate the kinetics of Stx

Conditions

• Hemolytic-Uremic Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	INM004	Two doses of Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab´)2 fragments at a dosage of 4 mg/kg of body weight, 24 hours apart. Each vial contains 25 mg of protein/ml. Therefore, each subject must receive 0.16 ml/kg per dose. The vial volume will be reconstituted in a 100 ml (for subjects with a body weight of 20 kg or more) or 50 ml (for subjects under 20 kg of body weight) infusion bag. It will be administered as an intravenous infusion using an infusion pump over a period of 50 minutes. In subjects with a BMI over 30 kg/m2, infusion will be performed over a period of 100 minutes
OTHER	Placebo	Two doses of placebo, 24 hours apart. The placebo solution has the same composition of excipients as INM004 without the active pharmaceutical ingredient, and its appearance is identical. Each subject must receive 0.16 ml/kg of placebo solution per dose. The vial volume will be reconstituted in a 100 ml (for subjects with a body weight of 20 kg or more) or 50 ml (for subjects under 20 kg of body weight) infusion bag. It will be administered as an intravenous infusion using an infusion pump over a period of 50 minutes. In subjects with a BMI over 30 kg/m2, infusion will be performed over a period of 100 minutes

Timeline

• Start date: 2024-10-05
• Primary completion: 2026-08-30
• Completion: 2026-12-31
• First posted: 2024-04-29
• Last updated: 2026-01-15

Locations

52 sites across 9 countries: Argentina, Belgium, France, Germany, Ireland, Italy, Romania, Spain, United Kingdom