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Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 in Participants with Congenital Adrenal Hyperplasia
EU CTIS ID: 2023-503488-40-00
What this study is testing
Safety Objective: To evaluate the safety and tolerability of CRN04894 Primary Efficacy Objective: To evaluate efficacy of CRN04894, measured by change from Baseline in serum androstenedione (A4)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female participants ≥18 to 75 years of age at the time of signing the Informed Consent Form (ICF). Participants ≥16 years of age may be included in sites located in the United States (US)
- Classic 21-hydroxylase deficiency confirmed by the Investigator and approved by the Medical Monitor.
- On a stable (defined as no dose change of >5 mg/day hydrocortisone equivalent (see Section 12.5) within 6 months prior to Screening) regimen of glucocorticoid replacement (eg, hydrocortisone, prednisolone, prednisone, methylprednisolone).
- Compliance, as judged per investigator discretion, with glucocorticoid replacement and mineralocorticoid replacement (if applicable) regimen documented during the Screening Period
- Minimum total daily dose of ≥15 mg hydrocortisone (or equivalent)
- If on estrogen therapy (any route), dose must be stable for at least 3 months prior to Screening.
You likely can't join if
- Diagnosis of any other form of CAH other than classic 21-hydroxylase deficiency
- History of unstable angina or acute myocardial infarction within 12 weeks prior to Screening or other clinically significant cardiac disease at the time of Screening as judged by the Investigator
- Concomitant mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study, and/or evidence of poor compliance with medical instructions
- History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ
- Women who are pregnant or lactating or, if of childbearing potential, who are unwilling to use highly effective contraception as described in this study. Male participants who are unwilling to use highly effective contraception as described in this study.
- Known history of illicit drug or alcohol abuse within the last year
See the full eligibility criteria
Who can join
- Male or female participants ≥18 to 75 years of age at the time of signing the Informed Consent Form (ICF). Participants ≥16 years of age may be included in sites located in the United States (US)
- Classic 21-hydroxylase deficiency confirmed by the Investigator and approved by the Medical Monitor.
- On a stable (defined as no dose change of >5 mg/day hydrocortisone equivalent (see Section 12.5) within 6 months prior to Screening) regimen of glucocorticoid replacement (eg, hydrocortisone, prednisolone, prednisone, methylprednisolone).
- Compliance, as judged per investigator discretion, with glucocorticoid replacement and mineralocorticoid replacement (if applicable) regimen documented during the Screening Period
- Minimum total daily dose of ≥15 mg hydrocortisone (or equivalent)
- If on estrogen therapy (any route), dose must be stable for at least 3 months prior to Screening.
What rules you out
- Diagnosis of any other form of CAH other than classic 21-hydroxylase deficiency
- History of unstable angina or acute myocardial infarction within 12 weeks prior to Screening or other clinically significant cardiac disease at the time of Screening as judged by the Investigator
- Concomitant mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study, and/or evidence of poor compliance with medical instructions
- History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ
- Women who are pregnant or lactating or, if of childbearing potential, who are unwilling to use highly effective contraception as described in this study. Male participants who are unwilling to use highly effective contraception as described in this study.
- Known history of illicit drug or alcohol abuse within the last year
- Use of antiandrogen therapy in the past 3 months (eg, spironolactone, finasteride, cyproterone acetate, flutamide)
- Use of testosterone, androgen-containing supplements, aromatase inhibitors, or growth hormone
- Dexamethasone or oral betamethasone use within 30 days of Screening
- History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy
- Night shift workers or any other reason for abnormal sleep/wake cycles
- Clinically significant medical condition or abnormal laboratory tests, as judged by the Investigator, other than CAH
- History of major surgery/surgical therapy for any cause within 4 weeks prior to Screening
- Diabetes mellitus treated with insulin for less than 6 weeks prior to Screening, or with change in total daily insulin dose by >15% within 6 weeks prior to Screening
- Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5%(≥69 mmol/mL), or estimated HbA1c based on fructosamine if HbA1c is not evaluable (eg, due to hemoglobinopathies)
- Participants with hypothyroidism who are not receiving adequate hormone replacement therapy based on thyroid hormone levels measured at the time of Screening, as determined by the Investigator
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Brazil
- India
- United Kingdom
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Brazil; India; United Kingdom; Argentina. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.