Tildacerfont for Congenital Adrenal Hyperplasia
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it mentions that participants should have been on a stable dose of glucocorticoid and mineralocorticoid replacements for at least one month before screening. This suggests you may continue your current medications.
What data supports the effectiveness of the drug Tildacerfont for treating Congenital Adrenal Hyperplasia?
Is Tildacerfont safe for humans?
Tildacerfont has been studied in adults with congenital adrenal hyperplasia, and while the research focuses on its ability to reduce certain hormone levels, it does not provide detailed safety data. However, it is important to note that clinical trials are designed to monitor safety, and any significant safety concerns would typically be reported.13467
How is the drug Tildacerfont unique in treating congenital adrenal hyperplasia?
What is the purpose of this trial?
This trial is testing Tildacerfont to see if it can help adults with classic CAH reduce their steroid doses. The study will initially compare Tildacerfont to another treatment for several months, then allow all participants to use Tildacerfont for an extended period, with an optional longer-term extension. The goal is to find a safer way to manage CAH by lowering the need for high steroid doses. Tildacerfont has been studied in earlier trials for adults with classic congenital adrenal hyperplasia (CAH).
Research Team
Ron Newfield, M.D
Principal Investigator
Rady Children's Hospital-San Diego and Professor of clinical pediatrics at UC San Diego School of Medicine.
Eligibility Criteria
This trial is for adults over 18 with classic Congenital Adrenal Hyperplasia (CAH) due to 21-hydroxylase deficiency. It's not open to those with other forms of CAH, a history of bilateral adrenalectomy, or hypopituitarism.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Double-blind, placebo-controlled treatment with Tildacerfont or placebo for 24 weeks
Open-label Treatment
All subjects receive open-label Tildacerfont for 52 weeks to continue reducing steroid dose and observe long-term safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label Extension (optional)
Participants may opt into continuation of treatment long-term for up to 240 weeks
Treatment Details
Interventions
- Placebo
- Tildacerfont
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spruce Biosciences
Lead Sponsor