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

NCT04544410 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-10-01

Study results available
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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.

Conditions

  • Congenital Adrenal Hyperplasia

Interventions

DRUG

Tildacerfont/Placebo

Tablet, administered daily

Sponsors & Collaborators

  • Spruce Biosciences

    lead INDUSTRY

Principal Investigators

  • Ron Newfield, M.D · Rady Children's Hospital-San Diego and Professor of clinical pediatrics at UC San Diego School of Medicine.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-22
Primary Completion
2024-10-31
Completion
2025-01-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Estonia
  • Germany
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • South Korea
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04544410 on ClinicalTrials.gov