Trial · NCT04544410
A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAH
NCT04544410, Phase 2, Terminated, Spruce Biosciences; results first posted 2025-10-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAH. Trials, record NCT04544410. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04544410
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAH
- NCT number
- NCT04544410
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- Spruce Biosciences
- Conditions
- Congenital Adrenal Hyperplasia
- Interventions
- Tildacerfont/Placebo
- First posted
- 2020-09-10
- Last updated
- 2025-10-01
- Results first posted
- 2025-10-01
- Limitations and caveats
Due to early termination of the study, not all assessments were performed. Additionally, due to protocol deviations, some assessments and samples were not collected therefore data are not available for every assessment from every participant.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Total Daily GC Dose in Subjects With Classic CAH Over the 24-week, Double Blind, Placebo-Controlled Treatment Period | 24 Weeks | 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 |
| Secondary | Effect of Tildacrfont in Reducing GC Use to Near-physiologic Levels While Maintaining Androgen Control in Subjects With CAH | 24 weeks | Proportion of subjects with GC dose ≤11mg/m2/day in HCe and A4 ≤1.2x baseline or A4 ≤ ULN at Week 24 |
| Secondary | Effect of Tildacrfont in Reducing GC Use to Near-physiologic Levels While Maintaining Androgen Control in Subjects With CAH | 24 Weeks | Proportion of subjects with baseline GC dose ≤ 35mg HCe who achieve GC dose ≤11 mg/m2/day in HCe and A4 ≤ 1.2x baseline or ≤ ULN at Week 24 |
| Secondary | Effectiveness in Reducing Cardiovascular Risk in Subjects With CAH | 24 Weeks | Proportion of subjects with improvement in at least one cardiovascular risk factor at Week 24 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Total Daily GC Dose in Subjects With Classic CAH Over the 24-week, Double Blind, Placebo-Controlled Treatment Period | 24 Weeks | mg | MEAN | |
| SECONDARY | Effect of Tildacrfont in Reducing GC Use to Near-physiologic Levels While Maintaining Androgen Control in Subjects With CAH | 24 weeks | Responders are subjects with glucocorticoid dose ≤11 mg/m2/day in HCe and A4 ≤ 1.2x Baseline or A4 ≤ ULN at Week 24. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Effect of Tildacrfont in Reducing GC Use to Near-physiologic Levels While Maintaining Androgen Control in Subjects With CAH | 24 Weeks | Responders are subjects with baseline glucocorticoid dose ≤ 35 mg HCe and glucocorticoid dose ≤11 mg/m2/day in HCe and A4 ≤ 1.2x Baseline or A4 ≤ ULN at Week 24. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Effectiveness in Reducing Cardiovascular Risk in Subjects With CAH | 24 Weeks | Responders are subjects with improvement in ≥ 1 baseline cardiovascular risk factor at Week 24. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Total Daily GC Dose in Subjects With Classic CAH Over the 24-week, Double Blind, Placebo-Controlled Treatment Period | Tildacerfont Group | -5.0 | Standard Deviation 8.91 | mg | |
| Change in Total Daily GC Dose in Subjects With Classic CAH Over the 24-week, Double Blind, Placebo-Controlled Treatment Period | Placebo | -4.3 | Standard Deviation 9.75 | mg | |
| Effect of Tildacrfont in Reducing GC Use to Near-physiologic Levels While Maintaining Androgen Control in Subjects With CAH | Tildacerfont Group | 4 | Participants | ||
| Effect of Tildacrfont in Reducing GC Use to Near-physiologic Levels While Maintaining Androgen Control in Subjects With CAH | Placebo | 5 | Participants | ||
| Effect of Tildacrfont in Reducing GC Use to Near-physiologic Levels While Maintaining Androgen Control in Subjects With CAH | Tildacerfont Group | 2 | Participants | ||
| Effect of Tildacrfont in Reducing GC Use to Near-physiologic Levels While Maintaining Androgen Control in Subjects With CAH | Placebo | 4 | Participants | ||
| Effectiveness in Reducing Cardiovascular Risk in Subjects With CAH | Tildacerfont Group | 26 | Participants | ||
| Effectiveness in Reducing Cardiovascular Risk in Subjects With CAH | Placebo | 19 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Treatment Period | STARTED | Tildacerfont Group | 48 | |
| Double-blind Treatment Period | STARTED | Placebo | 52 | |
| Double-blind Treatment Period | COMPLETED | Tildacerfont Group | 44 | |
| Double-blind Treatment Period | COMPLETED | Placebo | 50 | |
| Double-blind Treatment Period | NOT COMPLETED | Tildacerfont Group | 4 | |
| Double-blind Treatment Period | NOT COMPLETED | Placebo | 2 | |
| Open-Label Treatment Period | STARTED | Tildacerfont Group | 42 | |
| Open-Label Treatment Period | STARTED | Placebo | 50 | |
| Open-Label Treatment Period | COMPLETED | Tildacerfont Group | 20 | |
| Open-Label Treatment Period | COMPLETED | Placebo | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Back pain | Musculoskeletal and connective tissue disorders | Tildacerfont Group | 2 | 48 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 4 | 52 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Open Label Extension | 5 | 92 | |
| other | Headache | Nervous system disorders | Tildacerfont Group | 7 | 48 | |
| other | Headache | Nervous system disorders | Placebo | 9 | 52 | |
| other | Headache | Nervous system disorders | Open Label Extension | 9 | 92 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Tildacerfont Group | 2 | 48 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 3 | 52 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Open Label Extension | 3 | 92 | |
| other | Adrenal insufficiency | Endocrine disorders | Tildacerfont Group | 3 | 48 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tildacerfont Group | 0 | 48 |
| Total, all-cause mortality | Placebo | 0 | 52 |
| Total, all-cause mortality | Open Label Extension | 0 | 92 |
| Total, other adverse events | Tildacerfont Group | 11 | 48 |
| Total, other adverse events | Placebo | 16 | 52 |
| Total, other adverse events | Open Label Extension | 77 | 92 |
| Total, serious adverse events | Tildacerfont Group | 0 | 48 |
| Total, serious adverse events | Placebo | 0 | 52 |
| Total, serious adverse events | Open Label Extension | 2 | 92 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tildacerfont Group vs Placebo: Effect of Tildacrfont in Reducing GC Use to Near-physiologic Levels While Maintaining Androgen Control in Subjects With CAH | Trial comparisons |
| Tildacerfont Group vs Placebo: Effectiveness in Reducing Cardiovascular Risk in Subjects With CAH | Trial comparisons |
| Tildacerfont Group vs Placebo: Effect of Tildacrfont in Reducing GC Use to Near-physiologic Levels While Maintaining Androgen Control in Subjects With CAH | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04544410
GET https://conductscience.org/api/trials/v1/NCT04544410/events?page=2