drugset / Trial / NCT05664828

Efficacy of SN132D in Patients With Suspected Endometriosis

NCT05664828 ↗

Phase 2 Completed 8 enrolled Spago Nanomedical AB
NaSingle-groupOpen-labelDiagnostic

Summary

This is a Phase IIa, open-label, non-randomised and non-placebo-controlled study. The study is designed to evaluate the diagnostic value and safety of a single intravenous dose of SN132D in up to 18 participants with suspected endometriosis. Magnetic resonance imaging (MRI) will be performed pre- and post-infusion of SN132D.

Timeline

Start
2022-11-17
Primary completion
2023-06-20
Completion
2023-09-12

Outcome

Met primary endpoint

release “A preliminary analysis of data from the phase IIa clinical study SPAGOPIX-02 shows that SN132D has a good safety profile in patients with endometriosis.” reads as unknown spagonanomedical.se ↗

release “Further evaluation of the MRI contrast enhancing properties, particularly in lesions indicative of deep endometriosis, is ongoing.” reads as unknown spagonanomedical.se ↗

release “SPAGOPIX-02 med kontrastmedlet pegfosimer manganese (tidigare benämnt SN132D) bekräftar att det primära effektmåttet kontrastverkan vid MRT i endometrioslesioner har uppnåtts.” reads as met primary endpoint spagonanomedical.se ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject SN132D Unknown 0.02 mmol —

Indications