A Phase 2 Study to Evaluate the Safety, Efficacy and PK of Tildacerfont in Children with CAH

Last updated: February 5, 2025
Sponsor: Spruce Biosciences
Overall Status: Terminated

Phase

2

Condition

Congenital Adrenal Hyperplasia

Male Hormonal Deficiencies/abnormalities

Treatment

Tildacerfont

Clinical Study ID

NCT05128942
SPR001-205
  • Ages > 2
  • All Genders

Study Summary

An investigation of the safety and efficacy of tildacerfont in participants with CAH.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female subjects aged 2+

  • 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

Exclusion Criteria:

  • History of bilateral adrenalectomy or hypopituitarism

  • Clinically significant unstable medical conditions, illness, or chronic diseases

  • History of active bleeding disorders

  • Females who are pregnant or nursing

Study Design

Total Participants: 65
Treatment Group(s): 1
Primary Treatment: Tildacerfont
Phase: 2
Study Start date:
December 10, 2021
Estimated Completion Date:
January 31, 2025

Study Description

This is a study to evaluate the safety and efficacy of tildacerfont in participants with Congenital Adrenal Hyperplasia (CAH). Treatment will consist of 4 or 12 weeks of continuous dosing followed by safety follow up.

Connect with a study center

  • Spruce Study Site

    Sacramento, California 95821
    United States

    Site Not Available

  • Spruce Study Site

    San Diego, California 92123
    United States

    Site Not Available

  • Spruce Study Site

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Spruce Study Site

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Spruce Study Site

    Minneapolis, Minnesota 55454
    United States

    Site Not Available

  • Spruce Study Site

    Buffalo, New York 14203
    United States

    Site Not Available

  • Spruce Study Site

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Spruce Study Site

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Spruce Study Site

    Dallas, Texas 75231
    United States

    Site Not Available

  • Spruce Study Site

    Edinburg, Texas 78539
    United States

    Site Not Available

  • Spruce Study Site

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Spruce Study Site

    Plano, Texas 75093
    United States

    Site Not Available

  • Spruce Study Site

    Salt Lake City, Utah 84113
    United States

    Site Not Available

  • Spruce Study Site

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Spruce Study Site

    Richmond, Virginia 23284
    United States

    Site Not Available

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