Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04457336 · ClinicalTrials.gov registry record · Phase 2
A Ph2b to Evaluate Clinical Efficacy and Safety of Tildacerfont in Adult CAH
A Phase 2 study, sponsored by Spruce Biosciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
NCT04457336: Clinical Trial Phase 2 study, sponsored by Spruce Biosciences.
NCT04457336 is a Phase 2 study that was terminated before completion, run by Spruce Biosciences. The registered enrollment target is 96 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04457336, a Phase 2 study, was terminated before completion, sponsored by Spruce Biosciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
Study 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.
Primary Outcome
Assessment of dose response for change from baseline in log A4 after 12 weeks on double-blind placebo-controlled treatment (Week 18)
Interventions
- DRUG Tildacerfont/Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2020-08-26 |
| Est. Completion | 2024-05-23 |
| Phase | Phase 2 |
Why NCT04457336 stopped before completion
NCT04457336 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 1 intervention - of which Tildacerfont/Placebo is the first listed.
NCT04457336 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04457336 about?
NCT04457336 is a clinical study titled "A Ph2b to Evaluate Clinical Efficacy and Safety of Tildacerfont in Adult CAH". 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.
What is the current status of trial NCT04457336?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2020-08-26. Estimated completion is 2024-05-23.
What interventions are being tested in trial NCT04457336?
The interventions under investigation include: Tildacerfont/Placebo (DRUG).
Who is sponsoring clinical trial NCT04457336?
This trial is sponsored by Spruce Biosciences, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04457336's enrollment target sits among peer trials
96 747th of 2000 higher than 1,242 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03401762 · 96 participants · NA
Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke
- NCT03471260 · 96 participants · Phase 1
Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies
- NCT03549559 · 96 participants · NA
Imaging Histone Deacetylase in the Heart
- NCT03841058 · 96 participants · Phase 2
Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI