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Tildacerfont for Congenital Adrenal Hyperplasia

Phase 2
Recruiting
Led By Ron Newfield, M.D
Research Sponsored by Spruce Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female subjects over 18 years old, inclusive
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

Study Summary

This trial looks at whether Tildacerfont can help reduce the amount of glucocorticoid drugs needed to treat people with classic Congenital Adrenal Hyperplasia. The trial will last up to 76 weeks, with an optional extension up to 240 weeks.

Who is the study for?
This trial is for adults over 18 with classic Congenital Adrenal Hyperplasia (CAH) due to 21-hydroxylase deficiency. It's not open to those with other forms of CAH, a history of bilateral adrenalectomy, or hypopituitarism.Check my eligibility
What is being tested?
The study tests if Tildacerfont can reduce the need for high doses of glucocorticoids in CAH patients. Participants will receive either Tildacerfont or a placebo and may continue treatment up to 240 weeks.See study design
What are the potential side effects?
While specific side effects are not listed here, participants should be aware that they might experience unexpected reactions from taking Tildacerfont or the placebo during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 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
Proportion of subjects who can reduce GC dose at Week 24
Secondary outcome measures
Change in the median cumulative HCe dose in subjects with CAH
Effect on body weight in subjects with CAH
Effectiveness in improving HOMA-IR in subjects with CAH
+2 more
Other outcome measures
Change in acne in patients with CAH with acne at baseline
Change in hirsutism in female CAH subjects with hirsutism at baseline
Incidence of Adverse Events and Serious Adverse Events (safety analysis)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tildacerfont GroupExperimental Treatment1 Intervention
Tildacerfont administered daily via oral tablet for 24 weeks at dose level 1; followed by open label tildacerfont for 52 weeks
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered daily via oral tablet for 24 weeks; followed by open label tildacerfont for 52 weeks

Find a Location

Who is running the clinical trial?

Spruce BiosciencesLead Sponsor
5 Previous Clinical Trials
215 Total Patients Enrolled
Ron Newfield, M.DPrincipal InvestigatorRady Children's Hospital-San Diego and Professor of clinical pediatrics at UC San Diego School of Medicine.
Site NameJohns Hopkins
JH IRB Protocol NumberIRB00240450
Principal InvestigatorDr. Hamrahian

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04544410 — Phase 2
Congenital Adrenal Hyperplasia Research Study Groups: Tildacerfont Group, Placebo
Congenital Adrenal Hyperplasia Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04544410 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04544410 — Phase 2

Frequently Asked Questions

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

What are the potential risks associated with Tildacerfont Group?

"Tildacerfont Group's safety is rated a 2 by our team because it is still in Phase 2 trials. This suggests that while there is some data supporting its safety, there is no evidence yet of the medication's efficacy."

Answered by AI

Will this experiment still be helpful for those above the age of 60?

"The age limit for participants in this study is 55 years old. As long as patients are over the age of 18, they may be eligible to enroll."

Answered by AI

What are researchers hoping to discover through this study?

"The primary outcome of this study, which will be measured over the course of 24 weeks, is Change in GC dose at Week 24 according to the sponsor's report. Additionally, this trial will measure secondary outcomes such as weight loss (Absolute kg change in body weight), total cumulative HCe dose (Median total cumulative GC dose in HCe), and percent change in fat mass."

Answered by AI

Are there any current openings for volunteers in this research project?

"Yes, the information available on clinicaltrials.gov indicates that this study is still looking for patients to enroll. The trial was originally posted on September 29th 2020 and updated as recently as September 1st 2022. In total, 41 different sites across the country are recruiting and a total of 90 participants are needed."

Answered by AI

In how many different medical centers is this research project being organized and executed?

"Currently, patients are being enrolled at 42 different clinical sites, with 3 Spruce locations in Rhode island, Ohio, and Massachusetts."

Answered by AI

What is the sample size of this research project?

"In order for this clinical trial to be completed, 90 individuals who match the pre-specified inclusion criteria are needed. These potential participants can come from locations such as Spruce Site in Providence, Rhode island and Spruce Biosciences Clinical Site in Columbus, Ohio."

Answered by AI

How can I sign up for this clinical trial?

"This clinical trial is seeking 90 participants who have congenital adrenal hyperplasia, are between 18 and 55 years old, and meet the following additional criteria: a documented history of classic CAH due to 21-hydroxylase deficiency based on genetic mutation in CYP21A2 and/or documented elevated 17-OHP, currently receiving treatment with HC, HC acetate, prednisone, prednisolone, methylprednisolone (or a combination of the aforementioned GCs), been on a stable, supraphysiologic dose of GC replacement for ≥1 month before screening., For subjects with"

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
How old are they?
65+
18 - 65
What site did they apply to?
Spruce Study Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Spruce Study Site: < 24 hours
Recent research and studies
clinicaltrials.govStudy
A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAH
2020. "A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04544410.
All > Magic Congenital Adrenal Hyperplasia
~13 spots leftby Dec 2024
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