NCT03053271

A Study of ATR-101 for the Treatment of Endogenous Cushing's Syndrome

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ATR-101 for the Treatment of Cushing's Syndrome

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Millendo Therapeutics US, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 multicenter, randomized, double-blind, placebo controlled study of ATR-101 to evaluate the efficacy and safety of orally-administered ATR-101 in adults with endogenous Cushing's syndrome. Following wash-out (if needed), all eligible subjects will enter an open-label intra-subject dose-escalation period of 8 weeks' duration, followed either by a double-blind randomized withdrawal period of 4 weeks' duration (if the subject meets randomization criteria) or by an additional open label dosing period of 4 weeks' duration (if the subject does not meet randomization criteria).It is anticipated that the overall duration of the study per subject will range from approximately 16-22 weeks.

Conditions

• Cushing Syndrome

Interventions

Type	Name	Description
DRUG	ATR-101	During the 4-week randomized withdrawal period, subjects will be dosed for 4 weeks at the same dose level being used at the completion of the open-label dose-escalation period.
DRUG	Placebo	During the 4-week randomized withdrawal period, subjects will be dosed for 4 weeks with placebo that matches the same ATR-101 dose level being used at the completion of the open-label dose-escalation period.

Timeline

• Start date: 2017-04-13
• Primary completion: 2019-06-17
• Completion: 2019-08-12
• First posted: 2017-02-15
• Last updated: 2021-03-02
• Results posted: 2021-03-02

Locations

4 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study