A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment

eurocrine Biosciences, Inc.0 sites165 target enrollmentMay 19, 2020

ConditionsClassic Congenital Adrenal Hyperplasia (CAH)MedDRA version: 20.0Level: LLTClassification code 10010323Term: Congenital adrenal hyperplasiaSystem Organ Class: 100000004850 Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Classic Congenital Adrenal Hyperplasia (CAH)
Sponsor: eurocrine Biosciences, Inc.
Enrollment: 165
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 19, 2020

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

eurocrine Biosciences, Inc.

Eligibility Criteria

Inclusion Criteria

•Subjects must provide written informed consent.
•Be a female or male at least 18 years of age.
•Have a medically confirmed diagnosis of classic 21\-hydroxylase deficiency.
•Be on a stable, supraphysiologic glucocorticoid dose regimen (defined as \>13mg/m2/day in hydrocortisone dose equivalents)that has been stable for at least 1 month prior to screening
•If treated with fludrocortisone, dose should be stable for at least 1 month prior to screening with an upright plasma renin activity (PRA) during screening range that is not greater than ULN on the subject’s usual sodium intake.
•Female subjects of childbearing potential with fertile male partners must agree to use contraception consistently from screening until the final study visit or 30 days after the last dose of study drug, whichever is longer. A subject who is not of childbearing potential must meet one of the following:
•Postmenopausal
•Permanent sterilization procedure.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

Exclusion Criteria

•Have a known or suspected diagnosis of any of the other forms of classic CAH including 11\-ß\-hydroxylase deficiency, 17\-a\-hydroxylase deficiency, 3\-ß\-hydroxysteroid dehydrogenase deficiency, P450 side\-chain cleavage deficiency, or P450 oxidoreductase deficiency.
•Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic therapy with oral, glucocorticoids, or requiring chronic therapy with inhaled glucocorticoids that based on dose and hormone profile the investigator deems would yield significant systemic exposure interfering with study endpoints.
•Have a clinically significant medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular, gastrointestinal, significant malabsorption, hematologic, pulmonary, psychiatric, or endocrine disease \[excluding CAH]) that in the opinion of the investigator would preclude the subject from participating in and completing the study or that could confound interpretation of study outcome.
•History of malignancy, unless successfully treated with curative intent and considered to be cured.
•Have a known history of clinically concerning cardiac arrhythmia (including long QT syndrome) or prolongation of screening (pre\-treatment) QT interval corrected for heart rate using Fridericia’s correction (QTcF) of \>450 msec (males) or \>470 msec (females).
•Known sensitivity (ie, hypersensitivity) or allergy to any corticotropin\-releasing hormone (CRH) receptor antagonist.
•Have evidence of chronic renal or liver disease
•Used any active investigational drug in the context of a clinical trial within 30 days or 5 half\-lives (whichever is longer) before screening, or plans to use such an investigational drug (other than the study drug) during the study.
•Females who are pregnant or lactating.