A Study of ATR-101 for the Treatment of Congenital Adrenal Hyperplasia
Completed · Phase 2 · Has a placebo group
Conditions studied: Congenital Adrenal Hyperplasia
In brief
This is a Phase 2 multicenter, single-blind, multiple dose study to evaluate the safety and efficacy of orally administered ATR-101 in subjects with classic congenital adrenal hyperplasia (CAH). Treatment duration will range from a minimum of approximately 2 months to 6 months per subject. A subject may receive a minimum of one dose level or up to a maximum of 5 dose levels, in sequentially increasing dose strengths. Each dose level will last 28 days.
Key facts
- Study ID
- NCT02804178
- Run by
- Millendo Therapeutics, Inc.
- People needed
- 10
- Starts
- 2016-05-18
- Expected to finish
- 2017-08-17
- Last updated by the study team
- 2021-03-10
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Documented historical diagnosis of classic CAH due to 21-hydroxylase deficiency based on: Documented genetic mutation in the CYP21A2 enzyme consistent with a diagnosis of classic CAH, or historical documentation of elevated 17-hydroxyprogesterone
- Biochemical marker of disease status of 17-hydroxyprogesterone ≥ 4 times the upper limit of normal
- Chronic glucocorticoid replacement therapy for at least 6 consecutive months
- Stable glucocorticoid and mineralocorticoid regimen for at least 1 month
You may not qualify if…
- Non-classic CAH
- Other causes of adrenal insufficiency
- Surgery within the previous 3 months prior to screening or planned surgery during study participation
- History of active cancer requiring medical or surgical therapy within the past 6 months
Where it is running
- Johns Hopkins University — Baltimore, Maryland, United States
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Mayo Clinic - Rochester — Rochester, Minnesota, United States
- The University of Oklahoma - Tulsa Schusterman Center — Tulsa, Oklahoma, United States
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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