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New treatment option for Congenital Adrenal Hyperplasia
Official title A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia
ClinicalTrials.gov ID: NCT05669950
What this study is testing
What is Lu AG13909?
Lu AG13909 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for congenital adrenal hyperplasia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial will evaluate the effects of different doses of Lu AG13909 in adult participants with congenital adrenal hyperplasia, also called CAH. CAH is a rare genetic disorder that affects a person's ability to produce certain hormones.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Parts A and B:
- Confirmed diagnosis of 21-hydroxylase deficiency CAH (based on a pathogenic CYP21A2 variant and/or elevated 17-OHP).
- Morning (pre-glucocorticoid [GC] replacement dose) blood concentrations of 17-OHP \>4-times upper limit of normal (ULN).
- Body mass index (BMI) ≥18.5 kilograms (kg)/square meter (m\^2) (minimum 50 kg) and ≤40 kg/m\^2.
- Stable GC replacement therapy for ≥1 month prior to the Screening Visit.
You likely can't join if
- The participant is pregnant or breastfeeding.
- The participant has a clinically significant abnormal laboratory value, electrocardiogram (ECG) parameter, or vital signs value, or other safety...
- The participant has a history of known hypersensitivity or intolerance to Lu AG13909 or its excipients. Part C Only:
- The participant has received at least one dose of Lu AG13909 in Part A or Part B. Other inclusion and exclusion criteria may apply.
See the full eligibility criteria
- Parts A and B:
- Confirmed diagnosis of 21-hydroxylase deficiency CAH (based on a pathogenic CYP21A2 variant and/or elevated 17-OHP).
- Morning (pre-glucocorticoid [GC] replacement dose) blood concentrations of 17-OHP \>4-times upper limit of normal (ULN).
- Body mass index (BMI) ≥18.5 kilograms (kg)/square meter (m\^2) (minimum 50 kg) and ≤40 kg/m\^2.
- Stable GC replacement therapy for ≥1 month prior to the Screening Visit.
- For the salt-wasting form of CAH, the participant must have been on a stable dose of mineralocorticoid replacement for ≥3 months prior to the Screening Visit.
- Apart from CAH, the participant is generally healthy in the opinion of the investigator and based on medical history, physical examination, vital signs, ECGs, and the results of the safety laboratory tests. Part C:
- Confirmed diagnosis of 21-hydroxylase deficiency CAH (based on a pathogenic CYP21A2 variant and/or elevated 17-OHP).
- For Cohort C1 only: Morning (pre-GC replacement dose) blood concentrations of androgens (A4) \> ULN for age and sex.
- For Cohort C2 only: Morning (pre-GC replacement dose) blood concentrations of androgens (A4) ≤ ULN for age and sex and the participant is treated with high doses of GC.
- Stable GC replacement therapy for ≥1 month prior to the Screening Visit.
- For the salt-wasting form of CAH, the participant must have been on a stable dose of mineralocorticoid replacement for ≥1 month prior to the Screening Visit.
- The participant is pregnant or breastfeeding.
- The participant has a clinically significant abnormal laboratory value, electrocardiogram (ECG) parameter, or vital signs value, or other safety findings at the Screening Visit that indicate a potential risk for the...
- The participant has a history of known hypersensitivity or intolerance to Lu AG13909 or its excipients. Part C Only:
- The participant has received at least one dose of Lu AG13909 in Part A or Part B. Other inclusion and exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
- Copenhagen, Denmark
- Angers, France
- Lille, France
- Paris, France
- Strasbourg, France
- Tbilisi, Georgia
- Dublin, Ireland
- Bologna, Italy
- Roma, Italy
- Dobry Lekarz, Poland
- Gothenburg, Sweden
- Stockholm, Sweden
- Birmingham, United Kingdom
- Cambridge, United Kingdom
- London, United Kingdom
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 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States; Copenhagen, Denmark; Angers, France; Lille, France; Paris, France; Strasbourg, France and 10 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.