deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT05569746

A Study to Assess Safety, Efficacy, and Pharmacokinetics of INM004 in Pediatric Patients With STEC-HUS

A Phase II Study to Assess Safety, Efficacy, and Pharmacokinetics of INM004 (Anti-Shiga Toxin) in Pediatric Patients With Hemolytic Uremic Syndrome Associated With Shiga Toxin-producing Escherichia Coli Infection

Sponsor: Inmunova S.A.

Interventions INM004 SoC
Updated 8 times since 2022 Last updated: Aug 16, 2023 Started: Oct 6, 2022 Primary completion: May 15, 2023 Completion: Jul 14, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Diarrhea-Associated Hemolytic Uremic Syndrome and Hemolytic-Uremic Syndrome and is currently completed. Inmunova S.A. leads this study, which shows 8 recorded versions since 2022 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Nov 2022 – ~Feb 2023 · 3 months · monthly snapshotNot Yet Recruiting~Feb 2023 – ~Jul 2023 · 5 months · monthly snapshotRecruiting~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshotActive Not Recruiting~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshotActive Not Recruiting~Sep 2023 – ~Jul 2024 · 10 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 11 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Sep 2023 — Jul 2024 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  5. Aug 2023 — Sep 2023 [monthly]

    Active Not Recruiting PHASE2

Show 3 earlier versions
  1. Jul 2023 — Aug 2023 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  2. Feb 2023 — Jul 2023 [monthly]

    Recruiting PHASE2

    Status: Not Yet RecruitingRecruiting

  3. Nov 2022 — Feb 2023 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Oct 2022

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Inmunova S.A.
  • KLIXAR
  • Linical Co., Ltd.
  • PHV LATAM
Data source: Inmunova S.A.

For direct contact, visit the study record on ClinicalTrials.gov .