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Corticosteroid

Tildacerfont for Congenital Adrenal Hyperplasia

Phase 2
Recruiting
Research Sponsored by Spruce Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable dose of GC replacement for at least 1 month prior to screening
Male and female subjects aged 2 to 17 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks or 12 weeks
Awards & highlights

Study Summary

This trial looks at whether the drug Tildacerfont is safe for children with Congenital Adrenal Hyperplasia.

Who is the study for?
This trial is for children aged 2 to 17 with Congenital Adrenal Hyperplasia (CAH) due to 21-hydroxylase deficiency. They must have been on a stable dose of glucocorticoid replacement for at least one month. It's not suitable for those without this specific CAH type, who've had both adrenal glands removed, have unstable medical conditions, are pregnant or nursing females, or have bleeding disorders.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Tildacerfont in treating pediatric patients with CAH. This medication could potentially help manage hormone levels in these young patients.See study design
What are the potential side effects?
While the trial aims to establish the side effects of Tildacerfont in children with CAH, potential risks may include hormonal imbalances, growth issues, and typical drug-related reactions like nausea or rashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a stable dose of glucocorticoid replacement for at least 1 month.
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I am between 2 and 17 years old.
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I have CAH and need ongoing hormone therapy since my diagnosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks or 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks or 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Treatment-emergent adverse event (TEAE) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Secondary outcome measures
Proportion of participants who achieve a reduction in androstenedione (A4) or reduction in glucocorticoid (GC) dosing
Proportion of participants with elevated baseline A4 who achieve a reduction in A4
Proportion of participants with elevated baseline A4 who achieve a reduction in A4 who achieve A4 normalization
+1 more

Trial Design

9Treatment groups
Experimental Treatment
Group I: Cohort 9: Treatment with TildacerfontExperimental Treatment1 Intervention
Oral Tildacerfont administered daily for 4 consecutive weeks.
Group II: Cohort 8: Treatment with TildacerfontExperimental Treatment1 Intervention
Oral Tildacerfont administered daily for 4 consecutive weeks.
Group III: Cohort 7: Treatment with TildacerfontExperimental Treatment1 Intervention
Oral Tildacerfont administered daily for 4 consecutive weeks.
Group IV: Cohort 6: Treatment with TildacerfontExperimental Treatment1 Intervention
Oral Tildacerfont administered twice daily for 4 consecutive weeks.
Group V: Cohort 5: Treatment with TildacerfontExperimental Treatment1 Intervention
Oral Tildacerfont administered daily for 4 consecutive weeks.
Group VI: Cohort 4: Treatment with TildacerfontExperimental Treatment1 Intervention
Oral Tildacerfont administered daily for 4 consecutive weeks.
Group VII: Cohort 3: Age 2-10 Treatment with TildacerfontExperimental Treatment1 Intervention
Oral Tildacerfont administered daily for 12 consecutive weeks.
Group VIII: Cohort 2: Age 11-17 Treatment with TildacerfontExperimental Treatment1 Intervention
Oral Tildacerfont administered daily for 12 consecutive weeks.
Group IX: Cohort 1: Age 11-17 Treatment with TildacerfontExperimental Treatment1 Intervention
Oral Tildacerfont administered daily for 12 consecutive weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tildacerfont
2022
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Spruce BiosciencesLead Sponsor
5 Previous Clinical Trials
250 Total Patients Enrolled
Dennis AguilingStudy DirectorDirector of Clinical Operations
Will Charlton, MDStudy DirectorSpruce Biosciences
6 Previous Clinical Trials
648 Total Patients Enrolled

Media Library

Tildacerfont (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05128942 — Phase 2
Congenital Adrenal Hyperplasia Research Study Groups: Cohort 7: Treatment with Tildacerfont, Cohort 4: Treatment with Tildacerfont, Cohort 6: Treatment with Tildacerfont, Cohort 8: Treatment with Tildacerfont, Cohort 5: Treatment with Tildacerfont, Cohort 9: Treatment with Tildacerfont, Cohort 1: Age 11-17 Treatment with Tildacerfont, Cohort 2: Age 11-17 Treatment with Tildacerfont, Cohort 3: Age 2-10 Treatment with Tildacerfont
Congenital Adrenal Hyperplasia Clinical Trial 2023: Tildacerfont Highlights & Side Effects. Trial Name: NCT05128942 — Phase 2
Tildacerfont (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05128942 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age limit for those wishing to participate in the research project?

"This trial is open to children aged between 6 and 17, with a total of 28 different clinical trials available for minors. Additionally, there are 105 distinct medical studies that cater towards elderly individuals above the age of 65."

Answered by AI

Has Tildacerfont received regulatory approval from the Food and Drug Administration?

"This new treatment, tildacerfont, has not been tested for efficacy yet but there is sufficient clinical data to suggest it's safe. Therefore the safety rating of 2 was assigned by our team at Power."

Answered by AI

Is there still an opportunity for individuals to enter this clinical trial?

"Affirmative. Clinicaltrials.gov implies that this clinical trial, initiated on December 10th 2021, is presently searching for participants. Around 20 patients are needed from four separate medical centres."

Answered by AI

How many participants have been recruited for this research project?

"For this clinical trial to commence, 20 fitting candidates are needed. Eligible applicants can join from either the University of Virginia in Charlottesville or from the University of Utah located in Salt Lake City."

Answered by AI

What sort of patient is most apt to join this clinical research?

"To be considered for the trial, participants must have a diagnosis of adrenocortical hyperfunction and fall within the age range of 6 to 17. The total number of enrollees is limited to 20 individuals."

Answered by AI

How many North American sites are currently running this research project?

"Four medical institutions are currently taking part in this trial: University of Virginia (Charlottesville), University of Utah (Salt Lake City), Indiana University Hospital (Indianapolis) and four other sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 2 Study to Evaluate the Safety, Efficacy and PK of Tildacerfont in Children With CAH
2021. "A Phase 2 Study to Evaluate the Safety, Efficacy and PK of Tildacerfont in Children With CAH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05128942.
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