A Phase 2 Study to Evaluate the Safety, Efficacy and PK of Tildacerfont in Children Aged 2-17 Years With CAH

NCT05128942 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-12-24

Study results available
· View outcomes & findings →

Summary

An investigation of the safety and efficacy of tildacerfont in participants with CAH.

Conditions

  • Congenital Adrenal Hyperplasia
  • 21-OHD

Interventions

DRUG

Tildacerfont

Oral tablet formulation taken once daily in combination with glucocorticoid therapy.

Sponsors & Collaborators

  • Spruce Biosciences

    lead INDUSTRY

Principal Investigators

  • Will Charlton, MD · Spruce Biosciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2025-01-31
Completion
2025-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05128942 on ClinicalTrials.gov