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

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.

Timeline

Start

2020-08-26

Primary completion

2024-02-09

Completion

2024-05-23

Outcome

Missed primary endpoint

Stopped: “Study SPR001-203 did not meet its primary and secondary endpoints therefore Spruce Biosciences has decided to terminate the study”

release “CAHmelia-203 Study of Tildacerfont in Adult Classic Congenital Adrenal Hyperplasia (CAH) with Severe Hyperandrogenemia Did Not Meet Primary Efficacy Endpoint” sprucebio.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tildacerfont	Small molecule	200 mg	Oral

Indications