NCT03669549

Nevanimibe HCl for the Treatment of Classic CAH

A Multicenter Dose-Titration Open-Label Study of Nevanimibe Hydrochloride for the Treatment of Classic Congenital Adrenal Hyperplasia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Millendo Therapeutics US, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, intra-subject dose-titration open-label study of nevanimibe hydrochloride (HCl) for the treatment of classic congenital adrenal hyperplasia (CAH). Following a Screening Period of approximately 2-14 weeks, eligible subjects will enter a Baseline Period of approximately 2-8 weeks and then a 16-week Treatment Period. It is anticipated that the overall duration of the study per subject will range from 24-42 weeks.

Conditions

• Congenital Adrenal Hyperplasia

Interventions

Type	Name	Description
DRUG	Nevanimibe hydrochloride	During the 16-week treatment period, all subjects will begin dosing with nevanimibe HCl 500 mg BID and be dose titrated to 1000 mg BID, 1500 mg BID, and 2000 mg BID as needed based on serum 17-OHP assessments every 4 weeks.

Timeline

• Start date: 2018-07-11
• Primary completion: 2020-06-03
• Completion: 2020-07-12
• First posted: 2018-09-13
• Last updated: 2021-03-04
• Results posted: 2021-03-04

Locations

11 sites across 5 countries: Brazil, Czechia, France, Israel, Spain