Health TrialsbyHealthPanel

An Extension Trial of Asedebart in Participants With Congenital Adrenal Hyperplasia

ConditionAdrenal Hyperplasia, Congenital
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorH. Lundbeck A/S

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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/m²) (adjusted for body surface area in hydrocortisone equivalent dosage [HCe]) for >= 1 month prior to the Screening Visit.

elevated androgen blood concentrations (A4 > upper limit of normal (ULN) for age and sex) in morning measurements (pre-GC replacement dose) OR

Disqualifiers

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).

Trial design

Design model

Sequential

Treatments tested in this trial

  • Asedebart

    Drug

    Solution for injection/infusion

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: AsedebartExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Time frame
Up to 42 months

Secondary outcomes

1

Serum Concentration of Asedebart

Time frame
Up to 42 months
2

Area Under the Asedebart Serum Concentration-time Curve in a Dosing Interval (AUC0-tau)

Time frame
Up to 73 days
3

Area Under the Asedebart Serum Concentration-time Curve From Start of Injection to 28 days Post-dose (AUC0-4W)

Time frame
Up to 73 days
4

Maximum Observed Serum Concentration of Asedebart (Cmax)

Time frame
Up to 73 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lundbeck A/S

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: