drugset / Trial / NCT06194188

A Phase 2 Clinical Study of CU-20401

NCT06194188 ↗

Phase 2 Completed 108 enrolled Cutia Therapeutics (Wuxi) Co., Ltd
RandomizedSequentialOpen-labelTreatment

Summary

This is a randomized, double-blind, placebo-controlled Phase Ⅱ clinical study to evaluate the efficacy, safety, and immunogenicity of CU-20401 for Injection in a population with moderate to severe contour elevation or over-fullness due to SMF accumulation.

Timeline

Start
2023-12-20
Primary completion
2024-09-02
Completion
2024-09-02

Outcome

Met primary endpoint

release “In terms of efficacy, primary efficacy endpoint results demonstrated that the treatment efficacy of both the low dosage and high dosage groups of CU-20401 were superior to that of the placebo-controlled group” cutiatx.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject CU-20401 Unknown 0.06 mg —
Subject CU-20401 Unknown 0.08 mg —

Indications

No indication recorded.