Clinical Trial: A Study of ATR-101 for the Treatment of Endogenous Cushing's Syndrome
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ATR-101 for the Treatment of Cushing's Syndrome
Brief 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, all eligible subjects will undergo a 6-week open-label dose escalation with ATR-101. Subjects who continue to be eligible will then undergo a 4-week randomized withdrawal period. It is anticipated that the overall duration of the study per subject will range from approximately 14-20 weeks.
Detailed Summary:
Sponsor: Millendo Therapeutics, Inc.
Current Primary Outcome: The proportion of subjects with either a normal 24-hr urinary free cortisol (UFC) or a reduction in 24-hr UFC of ≥ 50% relative to their baseline value [ Time Frame: Through Day 71 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The proportion of subjects with a normal 24-hr UFC [ Time Frame: Through Day 71 ]
- The proportion of subjects with a reduction in 24-hr UFC of ≥ 50% relative to their baseline value [ Time Frame: Through Day 71 ]
- The proportion of subjects with a normal 24-hr UFC [ Time Frame: Through Day 43 ]
- The proportion of subjects with a reduction in 24-hr UFC of ≥ 50% relative to their baseline value [ Time Frame: Through Day 43 ]
- The change in the 24-hr UFC [ Time Frame: From Day 43 to Day 71 ]
- The change in the 24-hr UFC [ Time Frame: Through Day 43 ]
- The proportion of subjects with a normal late night salivary cortisol [ Time Frame: Through Day 71 ]
- The proportion of subjects with a normal late night salivary cortisol [ Time Frame: Through Day 43 ]
- The change in the late night salivary cortisol [ Time Frame: From Day 43 to Day 71 ]
- The change in the late night salivary cortisol [ Time Frame: Through Day 43 ]
- The change from baseline in blood hormone levels [ Time Frame: Through study completion, up to 20 weeks ]
Original Secondary Outcome: Same as current
Information By: Millendo Therapeutics, Inc.
Dates:
Date Received: February 6, 2017
Date Started: February 16, 2017
Date Completion: November 2018
Last Updated: May 9, 2017
Last Verified: March 2017