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

NCT04457336 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-07-08

Study results available
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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.

Conditions

  • Congenital Adrenal Hyperplasia

Interventions

DRUG

Tildacerfont/Placebo

Tablet, administered daily

Sponsors & Collaborators

  • Spruce Biosciences

    lead INDUSTRY

Principal Investigators

  • Kyriakie Sarafoglou, M.D · Dept. of Pediatrics, Divisions of Endocrinology and Genetics & Metabolism, Univ. of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-26
Primary Completion
2024-02-09
Completion
2024-05-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Denmark
  • Estonia
  • Germany
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Romania
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • 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 NCT04457336 on ClinicalTrials.gov