drugset / Trial / NCT04544410

A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAH

NCT04544410 ↗

Phase 2 Terminated 100 enrolled Spruce Biosciences
RandomizedParallel-groupTriple-blindTreatment

Summary

An investigation of the ability of Tildacerfont to reduce supraphysiologic glucocorticoid dosing in classic Congenital adrenal hyperplasia (CAH) subjects up to 76 weeks of treatment. Optional open label extension up to 240 weeks.

Timeline

Start
2021-02-22
Primary completion
2024-10-31
Completion
2025-01-31

Outcome

Missed primary endpoint

Stopped: “Study did not meet its primary endpoint.”

release “CAHmelia-204 Study of 200mg Once-Daily ( QD) Tildacerfont in Adult Congenital Adrenal Hyperplasia (CAH) Did Not Achieve Primary Endpoint of Glucocorticoid (GC) Reduction” sprucebio.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Tildacerfont Small molecule — Oral