Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic CAH due to 21-hydroxylase deficiency. The study consists of a 6-month randomized, double-blind, placebo-controlled period, followed by 1 year of open-label treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 20 months for the core study and will be a variable amount of time per subject for the OLE (estimated to be approximately 3 years).

Official Title

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

Keywords

Congenital Adrenal Hyperplasia, Adrenogenital Syndrome, Adrenocortical Hyperfunction, Hyperplasia, Crinecerfont

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Be willing and able to adhere to the study procedures, including all requirements at the study center and return for the follow-up visit.
  2. Have a medically confirmed diagnosis of classic 21-hydroxylase deficiency CAH.
  3. Be on a stable regimen of steroidal treatment for CAH.
  4. Participants of childbearing potential must agree to use an acceptable method of contraception during the study.

You CAN'T join if...

  1. Have a diagnosis of any of the other known forms of classic CAH.
  2. Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy.
  3. Have a clinically significant unstable medical condition or chronic disease other than CAH.
  4. Have a history of cancer unless considered cured.
  5. Are pregnant.
  6. Have a known history of clinically significant arrhythmia or abnormalities on ECG.
  7. Have a known hypersensitivity to any corticotropin releasing hormone antagonists.
  8. Have received any other investigational drug within 30 days before initial screening or plan to use an investigational drug (other than the study drug) during the study.
  9. Have current substance dependence, or current substance (drug) or alcohol abuse.
  10. . Have had a blood loss ≥550 mL or donated blood or blood products within 8 weeks prior to the study.

Locations

  • Neurocrine Clinical Site accepting new patients
    San Francisco California 94143 United States
  • Neurocrine Clinical Site accepting new patients
    Los Angeles California 90027 United States
  • Neurocrine Clinical Site withdrawn
    Pasadena California 91105 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Neurocrine Biosciences
Links
Study website - Cahtalyst Study
ID
NCT04490915
Phase
Phase 3 Congenital Adrenal Hyperplasia Research Study
Study Type
Interventional
Participants
Expecting 165 study participants
Last Updated