ClinicalTrials.gov record NCT07859293
An Extension Trial of Asedebart in Participants With Congenital Adrenal Hyperplasia
Interventional, Open-label, Extension Trial of Asedebart (Lu AG13909) in Participants With Congenital Adrenal Hyperplasia
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is an open-label extension study that gives asedebart to people with classic congenital adrenal hyperplasia who previously received asedebart in trial 19873A (NCT05669950). The main goals are to study long-term safety, tolerability, how the drug behaves in the body, and its effects on hormone levels and steroid dosing. Participants receive asedebart per a prespecified dosing schedule and are followed for safety and blood measurements over months to years.
What it is studying. The study is testing long-term safety and tolerability of asedebart when given to people with classic CAH who previously received the drug. It will also measure how much drug is in the blood over time, whether the body develops antibodies to the drug, and whether hormone measurements (for example androstenedione and 17‑hydroxyprogesterone) and daily glucocorticoid dose change while on treatment.
What the researchers hope to learn. Scientific goals are to collect data on long-term safety and tolerability of asedebart; to describe its pharmacokinetics (serum concentrations, AUC, Cmax, Tmax, Ctrough); to record the occurrence of anti-drug antibodies; and to measure changes from baseline in morning androstenedione, 17‑hydroxyprogesterone, and daily glucocorticoid dose.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
The main goal of the trial is to study the long-term safety, how well people can handle the treatment, and how asedebart acts in the body and affects the body when used to treat classic congenital adrenal hyperplasia (CAH). The trial will include participants who have previously received asedebart in trial 19873A (NCT05669950).
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Asedebart
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- The participant has been treated with asedebart in a clinical trial.
- The participant had an acceptable benefit-risk assessment in the prior trial and would benefit from continued treatment with asedebart in the opinion of the investigator.
- For participants with > 12 weeks since their last dose of asedebart: The participant has been on a stable daily dose of GC replacement therapy of ≥ 8 milligram per square meter (mg/m\^2) (adjusted for body surface area in hydrocortisone equivalent dosage [HCe]) for >= 1 month prior to the Screening Visit.
- For participants with > 12 weeks since their last dose of asedebart: The participant is not adequately controlled on their current treatment and, at the Screening/Baseline Visit, has either:
- elevated androgen blood concentrations (A4 > upper limit of normal (ULN) for age and sex) in morning measurements (pre-GC replacement dose) OR
- androgen blood concentrations within the reference range (A4 <= ULN for age and sex) and is being treated with supraphysiological GC (GC daily dose > 13 mg/m\^2 adjusted for body surface area in HCe)
- Key
Exclusion criteria
- The participant has known hypersensitivity or intolerance to asedebart or its excipients.
- The participant has taken any investigational medicinal product (IMP) other than asedebart < 3 months or < 5 half-lives, whichever is longer, prior to the first dose of asedebart in this trial.
- The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.
- The participant has an increased risk of adrenal crisis in the opinion of the investigator (for example history of repeated adrenal crisis in recent years, history of adrenal crisis caused by reduction of GC dose).
- Other protocol-defined criteria apply.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will receive asedebart by injection or infusion according to a prespecified dosing schedule. The study will collect blood samples to measure serum asedebart concentrations and anti‑drug antibodies (some pharmacokinetic measures over about 73 days; antibody and safety monitoring up to 42 months). Morning hormone levels (androstenedione and 17‑hydroxyprogesterone) will be measured at baseline and at Months 12, 24, and 36, and researchers will record treatment‑emergent adverse events throughout participation. Overall follow-up and treatment may continue for up to 42 months.
How the study is structured. Open-label, single experimental arm (all participants receive asedebart) in a Phase 2 extension. Participants who previously received asedebart will get it again per a prespecified injection/infusion schedule. The study includes repeated blood tests to measure drug concentrations, anti-drug antibodies, and hormone levels, with safety monitoring and follow-up over months to years (outcomes reported up to 42 months for some measures; some pharmacokinetic measures up to 73 days).
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Adrenal Hyperplasia, Congenital. Does it apply to my diagnosis?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on congenital adrenal hyperplasia
Important dates
- Study start
- Oct 1, 2026 (estimated)
- Primary completion
- Jul 31, 2031 (estimated)
- Study completion
- Jul 31, 2031 (estimated)
- Target enrollment
- 45 participants (estimated)
- Last updated on registry
- Oct 5, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- H. Lundbeck A/S
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Email contact via H. Lundbeck A/S 📞 +45 36301311 ✉ HQ_Medinfo@Lundbeck.com
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.
Terms used on this page · explanations by MedicalUpdates.ai
- Screening Visit
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- Baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- upper limit of normal
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- investigational
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- 5 half-lives
- The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
- childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- Key Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Key Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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