Status:
RECRUITING
A Trial of Lu AG13909 in Adult Participants With Cushing's Disease
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Cushing's Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This trial will evaluate the effects of Lu AG13909 in adult participants with Cushing's disease (CD). CD is a rare and serious disorder where the body makes too much of a hormone called cortisol. The ...
Detailed Description
This trial is divided into 3 parts: * Part A, consisting of 3 periods: an intravenous (IV) Titration Period, a subcutaneous (SC) Period, and a Safety Follow up Period * Part B, consisting of 3 period...
Eligibility Criteria
Inclusion Criteria:
-
The participant is a man or woman with a confirmed diagnosis of adrenocorticotropic hormone (ACTH) driven CD of pituitary source as per current guidelines
-
Morning plasma ACTH levels > lower limit of normal (LLN) and
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Evidence of a pituitary origin of the excess ACTH:
i. Either MRI confirmation of pituitary adenoma >6 millimeters (mm), or ii. inferior petrosal sinus gradient >2, or iii. histopathology confirmation of ACTH-secreting tumour
-
The participant has a 24-hour UFC >1.5 × ULN (the mean of ≥3 days of 24-hour urine collection).
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Apart from CD and associated well-controlled comorbidities (for example, diabetes mellitus and hypertension), the participant is generally healthy in the opinion of the investigator and based on medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the safety laboratory tests.
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For participants on medical treatment for hypercortisolism due to CD, pre-defined washout periods must be completed prior to the Baseline efficacy assessments.
Exclusion Criteria:
-
The participant is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not willing to use adequate contraceptive methods.
-
The participant has a clinically significant abnormal laboratory value, ECG parameter, vital signs value, or other safety findings at the Screening Visit that indicate a potential risk to the participant's safety if enrolled, in the opinion of the investigator.
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The participant has a history of known hypersensitivity or intolerance to Lu AG13909 or its excipients.
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The participant has immediate need for pituitary surgery within 6 months from screening in the opinion of the investigator.
-
The participant has severe CD per investigator judgement; among others, this could be participants with:
i. poorly controlled hypertension ii. poorly controlled diabetes mellitus iii. severe psychiatric illness iv. compression of the optic chiasm causing any visual field defect or risk thereof v. very high risk of thromboembolic events
-
The participant had pituitary surgery <3 month prior to screening.
-
The participant had pituitary radiotherapy within the last 10 years.
Other protocol-defined criteria apply.
Key Trial Info
Start Date :
June 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06471829
Start Date
June 19 2024
End Date
November 30 2027
Last Update
February 18 2026
Active Locations (26)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109
2
Centre Hospitalier Universitaire d'Angers
Angers, Cedex 09, France, 49933
3
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception
Marseille, Europe, France, 13005
4
Hopital Louis Pradel
Bron, France, 69677