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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03053271
Recruitment Status : Terminated (Slow enrollment)
First Posted : February 15, 2017
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Millendo Therapeutics, Inc. ( Millendo Therapeutics US, Inc. )

Tracking Information
First Submitted Date  ICMJE February 6, 2017
First Posted Date  ICMJE February 15, 2017
Last Update Posted Date February 21, 2020
Actual Study Start Date  ICMJE April 13, 2017
Actual Primary Completion Date June 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
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 85 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2017)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
  • The proportion of subjects with a normal 24-hr UFC [ Time Frame: Through Day 85 ]
  • The proportion of subjects with a reduction in 24-hr UFC of ≥ 50% relative to their baseline value [ Time Frame: Through Day 85 ]
  • The proportion of subjects with a normal 24-hr UFC [ Time Frame: Through Day 57 and Day 85 ]
  • The proportion of subjects with a reduction in 24-hr UFC of ≥ 50% relative to their baseline value [ Time Frame: Through Day 57 and Day 85 ]
  • The change in the 24-hr UFC [ Time Frame: From Day 57 to Day 85 ]
  • The change in the 24-hr UFC [ Time Frame: Through Day 57 and Day 85 ]
  • The proportion of subjects with a normal late night salivary cortisol [ Time Frame: Through Day 85 ]
  • The proportion of subjects with a normal late night salivary cortisol [ Time Frame: Through Day 57 and Day 85 ]
  • The change in the late night salivary cortisol [ Time Frame: From Day 57 to Day 85 ]
  • The change in the late night salivary cortisol [ Time Frame: Through Day 57 and Day 85 ]
  • The change from baseline in blood hormone levels [ Time Frame: Through study completion, up to 22 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2017)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ATR-101 for the Treatment of Endogenous Cushing's Syndrome
Official Title  ICMJE 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 (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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cushing Syndrome
Intervention  ICMJE
  • 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.
    Other Name: nevanimibe HCl
  • 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.
Study Arms  ICMJE
  • Experimental: ATR-101
    During the 4-week randomized withdrawal period, eligible subjects will receive ATR-101 at the same dose level being used at the completion of the open-label dose-escalation period.
    Intervention: Drug: ATR-101
  • Placebo Comparator: Placebo
    During the 4-week randomized withdrawal period, eligible subjects will receive a placebo that matches the same ATR-101 dose level being used at the completion of the open-label dose-escalation period.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 17, 2019)
4
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2017)
16
Actual Study Completion Date  ICMJE August 12, 2019
Actual Primary Completion Date June 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03053271
Other Study ID Numbers  ICMJE ATR-101-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Millendo Therapeutics, Inc. ( Millendo Therapeutics US, Inc. )
Study Sponsor  ICMJE Millendo Therapeutics US, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Findling, MD Medical College of Wisconsin
PRS Account Millendo Therapeutics, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP