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An open-label study to evaluate the effect of crinecerfont on androgen reduction and related outcomes in adults with classic CAH
EU CTIS ID: 2025-524282-24-00
What this study is testing
To evaluate the effect of crinecerfont on elevated androstenedione levels in adults with classic CAH on a stable GC dose for at least 6 months.
- Therapeutic confirmatory (Phase III)
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
- Completed informed consent.
- CCI
- All participants must be ≥18 years of age . Female participants must also be ≤45 years of age.
- CCI. Female participants must have AMH ≥1 ng/mL and FSH <25 mIU/mL at screening.
- Have a medically confirmed diagnosis of classic 21-OHD CAH based on standard medically accepted criteria such as elevated 17-OHP level, confirmed CYP21A2 genotype, positive newborn screening with confirmatory second-tier testing, or cosyntropin stimulation
- Have androstenedione CCI (prior to morning GC dose) at screening
You likely can't join if
- Pregnant (ie, positive pregnancy test at screening or Day 1) or lactating, or plans to become pregnant during the study
- CCI
- CCI
- Have had hysterectomy or oophorectomy.
- Have evidence of chronic renal or liver disease based on any of these screening laboratory test abnormalities: • eGFRCr (CKD-EPI, 2021) <45ml/min per 1.73 m2. • AST >3 × ULN. • ALT >3 × ULN. • Total bilirubin >1.5 × ULN unless due to a documented diagnosis of Gilbert's syndrome.
- Have absolute neutrophil count <1.0 × 103/mm3at screening.
See the full eligibility criteria
Who can join
- Completed informed consent.
- CCI
- All participants must be ≥18 years of age . Female participants must also be ≤45 years of age.
- CCI. Female participants must have AMH ≥1 ng/mL and FSH <25 mIU/mL at screening.
- Have a medically confirmed diagnosis of classic 21-OHD CAH based on standard medically accepted criteria such as elevated 17-OHP level, confirmed CYP21A2 genotype, positive newborn screening with confirmatory second-tier testing, or cosyntropin stimulation
- Have androstenedione CCI (prior to morning GC dose) at screening
- Be on a GC dose regimen CCI HCe that has been stable for at least 1 month prior to screening; consists of 1 or more of the following orally administered GCs: hydrocortisone (including modified- or sustained-release hydrocortisone), prednisone, prednisolone, or methylprednisolone; and includes a morning dose of GC
- If treated with fludrocortisone, dose should be stable for at least 1 month prior to screening with an upright PRA during screening that is not greater than ULN on the participant’s usual sodium intake. If PRA is >ULN, the participant must have systolic blood pressure >100 mmHg, without orthostatic hypotension, and with serum sodium and potassium in the normal range.
- Participants with ovaries of childbearing potential must agree to use contraception consistently from screening until 30 days after the last dose of study treatment or final study visit, whichever is longer. Acceptable methods of contraception are required for participants with ovaries: • Bilateral salpingectomy or bilateral tubal occlusion • Intrauterine device or intrauterine hormone-releasing system. • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal, or transdermal, initiated at least 3 months prior to screening. • Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injected, or implanted initiated at least 3 months prior to screening. • Total abstinence from sexual intercourse (periodic abstinence is not acceptable). • Sexual partner(s) who had been vasectomized at least 3 months prior to screening with successful procedure. • Progesterone only where inhibition of ovulation is not the primary mode of action. • Male or female condom with or without spermicide. • Cap, diaphragm or sponge with spermicide.
- CCI
What rules you out
- Pregnant (ie, positive pregnancy test at screening or Day 1) or lactating, or plans to become pregnant during the study
- CCI
- CCI
- Have had hysterectomy or oophorectomy.
- Have evidence of chronic renal or liver disease based on any of these screening laboratory test abnormalities: • eGFRCr (CKD-EPI, 2021) <45ml/min per 1.73 m2. • AST >3 × ULN. • ALT >3 × ULN. • Total bilirubin >1.5 × ULN unless due to a documented diagnosis of Gilbert's syndrome.
- Have absolute neutrophil count <1.0 × 103/mm3at screening.
- Used any active investigational drug in the context of a clinical trial within 30 days or 5 half-lives (whichever is longer) before screening or plans to use such an investigational drug (other than the study drug) during the study.
- Have previously received a CRF1 antagonist, including crinecerfont, within 1 year before screening.
- Using any prohibited concomitant medication and cannot discontinue use of these medications for the duration of the study.
- Have current substance dependence or substance or alcohol abuse (drugs including controlled substance or non-prescribed use of prescription drugs; nicotine and caffeine dependence are not exclusionary).
- CCI
- Have a known or suspected diagnosis of any of the other forms of classic CAH including 11-β-hydroxylase deficiency, 17-α-hydroxylase deficiency, 3-β-hydroxysteroid dehydrogenase deficiency, P450 side-chain cleavage deficiency, or P450 oxidoreductase deficiency.
- Have a significant risk of suicidal or violent behavior. Participants with any suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) in the past 6 months before screening or any history of suicidal behavior within the past year based on the C-SSRS should be excluded.
- Have had a blood loss ≥550 mL or donated blood or blood products within 8 weeks before Day 1.
- In the investigator’s opinion, the participant is not capable of adhering to the protocol requirements
- Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic therapy with oral GCs, or requiring chronic therapy with inhaled GCs that based on dose and hormone profile the investigator deems would yield significant systemic exposure interfering with study endpoints
- Have received dexamethasone for chronic use in the 6 months before screening.
- At increased risk of developing adrenal crisis in the investigator’s opinion, based on, for example, repeated history of adrenal crisis in the past, prior history of adrenal crisis precipitated by reducing GC dose, recent episode(s), etc.
- CCI
- Have a clinically significant medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular, GI, significant malabsorption, hematologic, pulmonary, psychiatric, or endocrine disease [excluding CAH]) that in the opinion of the investigator would preclude the participant from participating in and completing the study or that could confound interpretation of study outcomes
- History of malignancy, unless successfully treated with curative intent and considered to be cured.
- Known sensitivity (ie, hypersensitivity) or allergy to any corticotropin-releasing hormone (CRH) receptor antagonist or to any component of the study treatment
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Serbia
- Argentina
- Turkey
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, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Serbia; Argentina; Turkey. 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.