A Ph2b to Evaluate Clinical Efficacy and Safety of Tildacerfont in Adult CAH

  • STATUS
    Recruiting
  • End date
    Nov 22, 2024
  • participants needed
    72
  • sponsor
    Spruce Biosciences
Updated on 7 October 2022
Investigator
Clinical Trials
Primary Contact
Spruce Clinical Site (7.2 mi away) Contact
+56 other location
prednisone
deficiency
prednisolone
17-hydroxyprogesterone
21-ohd

Summary

An investigation of the efficacy and safety of up to 70 weeks of treatment with Tildacerfont in subjects with classic CAH who have elevated biomarkers at baseline on their current GC regimen. Optional open label treatment extension period up to 240 weeks with 200mg tildacerfont QD.

Description

This is a study that will test the efficacy and safety of Tildacerfont. The first 12-weeks will be a double-blind, placebo controlled, dose ranging study. The following 58-weeks will assess the long term safety of Tildacerfont. Optional open label treatment extension period up to 240 weeks with 200mg tildacerfont QD.

Details
Condition Congenital Adrenal Hyperplasia
Treatment Tildacerfont/Placebo
Clinical Study IdentifierNCT04457336
SponsorSpruce Biosciences
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female subjects over 18 years old, inclusive
Has a known childhood diagnosis of classic CAH due to 21-hydroxylase deficiency based on genetic mutation in CYP21A2 and/or documented elevated 17-OHP and currently treated with HC, HC acetate, prednisone, prednisolone, methylprednisolone (or a combination of the aforementioned GCs)
Has been on a stable supraphsiologic dose of GC replacement ≥15 mg/day and ≤60 mg/day in HC equivalents
For subjects with the salt-wasting form of CAH, subject has been on a stable dose of mineralocorticoid replacement for ≥1 month before screening

Exclusion Criteria

Has a known or suspected diagnosis of any other known form of classic CAH (not due to 21 hydroxylase deficiency)
Has a history that includes bilateral adrenalectomy or hypopituitarism
Has a history of allergy or hypersensitivity to Tildacerfont, any of its excipients, or any other CRF1 receptor antagonist
Current treatment with dexamethasone as GC therapy for CAH. Prior treatment with dexamethasone is allowed as long as the transition to an alternative GC regimen (eg, HC, prednisone, or prednisolone) has resulted in a stable dose of GC replacement for ≥1 month before screening
Shows clinical signs or symptoms of adrenal insufficiency
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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