SPR001-203: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal Hyperplasia

About this Study

The purpose of this study is to determine the safety and effects of tildacerfont (SPR001), an investigational drug that may be used for congenital adrenal hyperplasia (CAH).

Sponsor Protocol ID:SPR001-203
IRB Number:2021-1092
Actively Enrolling
Phase 2
June 16, 2022
Eligibility Criteria
18 years old
Both Male and Female

Inclusion Criteria
  • Male and female over 18 years old
  • Diagnosis of classic congenital adrenal hyperplasia (CAH)
  • On stable dose of Glucocorticoid (GC) replacement

Exclusion Criteria
  • Known or suspected diagnosis of any other known form of classic CAH
  • History that includes bilateral adrenalectomy or hypopituitarism
  • History of allergy or hypersensitivity to Tildacerfont
  • Current treatment with dexamethasone as Glucocorticoid (GC) therapy for CAH
  • Clinical signs or symptoms of adrenal insufficiency

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Participating Locations
University Hospital - UMMC
Contact Information
Contact Name: Shelby Lee
Phone Number: 601-496-7831
Email: selee@umc.edu
Principal Investigator:Garla, Vishnu V, M.D.
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