drugset / Trial / NCT04055909
Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomized, double-blind, placebo-controlled dose-selection study in which two doses of nangibotide are tested versus placebo.
Timeline
- Start
- 2019-11-13
- Primary completion
- 2022-05-09
- Completion
- 2023-05-09
Outcome
Missed primary endpoint
paper This trial did not achieve the primary outcome of improvement in SOFA score at the predefined sTREM-1 value. PMID 37269870 ↗
Publications
- Francois B, Lambden S, Fivez T, Gibot S, Derive M, Grouin JM, Salcedo-Magguilli M, Lemarie J, De Schryver N, Jalkanen V, Hicheur T, Garaud JJ, Cuvier V, Ferrer R, Bestle M, Pettila V, Mira JP, Bouisse C, Mercier E, Vermassen J, Huberlant V, Vinatier I, Anguel N, Levy M, Laterre PF; ASTONISH investigators. Prospective evaluation of the efficacy, safety, and optimal biomarker enrichment strategy for nangibotide, a TREM-1 inhibitor, in patients with septic shock (ASTONISH): a double-blind, randomised, controlled, phase 2b trial. Lancet Respir Med. 2023 Oct;11(10):894-904. doi: 10.1016/S2213-2600(23)00158-3. Epub 2023 May 31.
- Francois B, Lambden S, Gibot S, Derive M, Olivier A, Cuvier V, Witte S, Grouin JM, Garaud JJ, Salcedo-Magguilli M, Levy M, Laterre PF. Rationale and protocol for the efficacy, safety and tolerability of nangibotide in patients with septic shock (ASTONISH) phase IIb randomised controlled trial. BMJ Open. 2021 Jul 7;11(7):e042921. doi: 10.1136/bmjopen-2020-042921.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | nangibotide | Peptide | 0.3 mg/kg | Intravenous |
| Subject | nangibotide | Peptide | 1 mg/kg | Intravenous |
Indications
No indication recorded.