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Terminated Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT04457336

Public ClinicalTrials.gov record NCT04457336. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 12:25 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects With Classic Congenital Adrenal Hyperplasia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04457336
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
Spruce Biosciences
Industry
Enrollment
96 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 26, 2020 (Actual)
Primary completion
Feb 9, 2024 (Actual)
Completion
May 23, 2024 (Actual)
Last update posted
Jul 8, 2025

2020 – 2024

United States locations

U.S. sites
28
U.S. states
17
U.S. cities
27
Facility City State ZIP Site status
Spruce Study Site Birmingham Alabama 35294 —
Spruce Study Site Los Angeles California 90027 —
Spruce Clinical Site Orange California 92868 —
Spruce Study Site Sacramento California 95817 —
Spruce Study Site Englewood Colorado 80113 —
Spruce Clinical Site Tampa Florida 33612 —
Spruce Study Site West Palm Beach Florida 33401 —
Spruce Study Site Chicago Illinois 60611 —
Spruce Clinical Site Indianapolis Indiana 46202 —
Spruce Study Site Baltimore Maryland 21287 —
Spruce Clinical Site Minneapolis Minnesota 55454 —
Spruce Study Site Rochester Minnesota 55905 —
Spruce Clinical Site Las Vegas Nevada 89148 —
Spruce Study Site Hickory North Carolina 28601 —
Spruce Study Site Canton Ohio 44718 —
Spruce Study Site Cincinnati Ohio 45219 —
Spruce Study Site Cleveland Ohio 44195 —
Spruce Study Site Columbus Ohio 43210 —
Spruce Clinical Site Bend Oregon 97702 —
Spruce Study Site Philadelphia Pennsylvania 19104 —
Spruce Study Site Philadelphia Pennsylvania 19107 —
Spruce Study Site Providence Rhode Island 02903 —
Spruce Study Site Columbia South Carolina 28203 —
Spruce Clinical Site Memphis Tennessee 38163 —
Spruce Study Site Austin Texas 78731 —
Spruce Study Site Dallas Texas 75093 —
Spruce Clinical Site Edinburg Texas 78539 —
Spruce Clinical Site Fort Worth Texas 76104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 37 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04457336, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 8, 2025 · Synced Oct 22, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04457336 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →