A Phase 2 Study to Evaluate the Safety, Efficacy and PK of Tildacerfont in Children Aged 2-17 Years With CAH
NCT ID: NCT05128942
Last Updated: 2025-12-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
67 participants
INTERVENTIONAL
2021-12-10
2025-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1: Age 11-17 Treatment with Tildacerfont
50 mg daily for 12 consecutive weeks.
Tildacerfont
Oral tablet formulation taken once daily in combination with glucocorticoid therapy.
Cohort 2: Age 11-17 Treatment with Tildacerfont
200 mg daily for 12 consecutive weeks.
Tildacerfont
Oral tablet formulation taken once daily in combination with glucocorticoid therapy.
Cohort 3: Age 2-10 Treatment with Tildacerfont
50, 100, or 200 mg daily for 12 consecutive weeks.
Tildacerfont
Oral tablet formulation taken once daily in combination with glucocorticoid therapy.
Cohort 4: Age >/= 18 Treatment with Tildacerfont
200 mg twice daily for 4 consecutive weeks.
Tildacerfont
Oral tablet formulation taken once daily in combination with glucocorticoid therapy.
Cohort 5: Age >/= 18 Treatment with Tildacerfont
300 or 400 mg twice daily for 4 consecutive weeks.
Tildacerfont
Oral tablet formulation taken once daily in combination with glucocorticoid therapy.
Cohort 6: Age 11-17 Treatment with Tildacerfont
200 mg twice daily for 4 consecutive weeks.
Tildacerfont
Oral tablet formulation taken once daily in combination with glucocorticoid therapy.
Cohort 7: Age 2-10 Treatment with Tildacerfont
200 mg twice daily for 4 consecutive weeks.
Tildacerfont
Oral tablet formulation taken once daily in combination with glucocorticoid therapy.
Cohort 8: Age 11-17 Treatment with Tildacerfont
300 or 400 mg twice daily for 4 consecutive weeks.
Tildacerfont
Oral tablet formulation taken once daily in combination with glucocorticoid therapy.
Cohort 9: Age 2-10 Treatment with Tildacerfont
300 or 400 mg twice daily for 4 consecutive weeks.
Tildacerfont
Oral tablet formulation taken once daily in combination with glucocorticoid therapy.
Interventions
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Tildacerfont
Oral tablet formulation taken once daily in combination with glucocorticoid therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of CAH due to 21-hydroxylase deficiency (OHD) and/or elevated 17- hydroxyprogesterone (OHP) requiring ongoing GC replacement since diagnosis
* Stable dose of GC replacement for at least 1 month prior to screening
Exclusion Criteria
* Clinically significant unstable medical conditions, illness, or chronic diseases
* History of active bleeding disorders
2 Years
ALL
No
Sponsors
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Spruce Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Will Charlton, MD
Role: STUDY_DIRECTOR
Spruce Biosciences
Locations
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Spruce Study Site
Sacramento, California, United States
Spruce Study Site
San Diego, California, United States
Spruce Study Site
Chicago, Illinois, United States
Spruce Study Site
Minneapolis, Minnesota, United States
Spruce Study Site
Buffalo, New York, United States
Spruce Study Site
Providence, Rhode Island, United States
Spruce Study Site
Columbia, South Carolina, United States
Spruce Study Site
Dallas, Texas, United States
Spruce Study Site
Edinburg, Texas, United States
Spruce Study Site
Fort Worth, Texas, United States
Spruce Study Site
Salt Lake City, Utah, United States
Spruce Study Site
Charlottesville, Virginia, United States
Spruce Study Site
Richmond, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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SPR001-205
Identifier Type: -
Identifier Source: org_study_id