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NCT04544410 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Spruce Biosciences.

Terminated
Registry status
Phase 2
Development phase
100
Enrollment target

NCT04544410: Clinical Trial Phase 2 study, sponsored by Spruce Biosciences.

NCT04544410 is a Phase 2 study that was terminated before completion, run by Spruce Biosciences. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04544410, a Phase 2 study, was terminated before completion, sponsored by Spruce Biosciences.

TERMINATED
Registry status
Phase 2
Development phase
100 participants
Enrollment target

Study 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.

Primary Outcome

Absolute change from baseline (Day 1) in GC dose in HCe at Week 24. The analysis of absolute change in total daily GC dose in HCe will include data from Weeks 3, 6, 12, 18 and 24 in a mixed model

Interventions

  • DRUG Tildacerfont/Placebo

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2021-02-22
Est. Completion 2025-01-31
Phase Phase 2
Spruce Biosciences

6 total trials

Why NCT04544410 stopped before completion

NCT04544410 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).

The record links to 0 conditions, and to 1 intervention - of which Tildacerfont/Placebo is the first listed.

NCT04544410 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04544410 about?

NCT04544410 is a clinical study titled "A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAH". 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.

What is the current status of trial NCT04544410?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2021-02-22. Estimated completion is 2025-01-31.

What interventions are being tested in trial NCT04544410?

The interventions under investigation include: Tildacerfont/Placebo (DRUG).

Who is sponsoring clinical trial NCT04544410?

This trial is sponsored by Spruce Biosciences, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04544410's enrollment target sits among peer trials

100 672nd of 2000 higher than 1,263 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

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Source: ClinicalTrials.gov NCT04544410, the US trial registry maintained by the National Library of Medicine. NCT04544410 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.