TerminatedPhase 2

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

Stopped: Slow enrollment

United States, United Kingdom4 participantsStarted 2017-04-13

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed diagnosis of endogenous Cushing's syndrome * Baseline UFC 1.3 to 10 × upper limit of normal (ULN) * If previous pituitary surgery, participants must be at least 3 months since surgery at the time of screening * BMI between 18 and 60 kg/m2, inclusive Exclusion Criteria: * Pseudo-Cushing's syndrome, cyclic Cushing's syndrome or current iatrogenic Cushing's syndrome * Candidates for surgical treatment of Cushing's syndrome, unless surgery is not anticipated to occur during the study * Normal late night salivary cortisol or 24-hr urine free cortisol * Radiotherapy of the pituitary within 6 months

What they're measuring

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

Timeframe: Through Day 85

Trial details

NCT IDNCT03053271

SponsorMillendo Therapeutics US, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-06-17

Results submitted2021-01-25