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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504733-53-00 | Other Identifier | CTIS |
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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 main goals of this trial are to learn about
This trial is divided into 3 parts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AG13909 | Experimental | Participants will first receive Lu AG13909 IV per predefined dosing schedule. Participants will then receive Lu AG13909 SC per predefined dosing schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG13909 | Drug | Solution for injection/infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A & Part B: Urinary Free Cortisol (UFC) Complete Response: mean UFC (mUFC) ≤ Upper Limit of Normal (ULN) at the end of the IV/SC Titration Period | Up to 490 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to 1023 days | |
| AUC0-tau,ss: Area Under the Plasma Concentration Curve of Lu AG13909 at Steady State | Up to 1037 days | |
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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
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).
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.
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.
The participant has a history of known hypersensitivity or intolerance to Lu AG13909 or its excipients.
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Email contact via H. Lundbeck A/S | Contact | +45 36301311 | HQ_Medinfo@Lundbeck.com |
| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | HQ_Medinfo@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States | |
| Centre Hospitalier Universitaire d'Angers |
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| CL: Systemic Clearance of Lu AG13909 |
| Up to 1037 days |
| t½: Elimination Half-life of Lu AG13909 | Up to 1037 days |
| Vd: Apparent Volume of Distribution of Lu AG13909 | Up to 1037 days |
| SC Bioavailability (F) of Lu AG13909 | Up to 1037 days |
| Number of Participants With Anti-Drug Antibodies (ADAs) | Up to 1037 days |
| Part A Only: Cmax: Maximum Observed Plasma Concentration of Lu AG13909 | Up to 323 days |
| Part A Only: Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Lu AG13909 | Up to 323 days |
| Part A & Part B: Ctrough: Minimum Observed Concentration of Lu AG13909 | Up to 659 days |
| Part A & Part B: Ttrough: Nominal Time Corresponding to the Occurrence of Ctrough | Up to 659 days |
| UFC Complete Response (mUFC ≤ ULN) or Partial Response (≥50% Reduction in UFC from Baseline and mUFC >ULN) at the End of the IV/SC Titration Period | Up to 491 days |
| Maintenance of UFC Complete Response (mUFC ≤ULN) at the End of the Part B Maintenance Period | Up to 337 days |
| Part A and Part B: Percentage Change from Baseline in mUFC at the End of the Titration Period and the Completion Visit | Baseline, up to 561 days |
| Part A and Part B: UFC Complete Response (mUFC ≤ ULN) or Partial Response (≥50% Reduction in UFC from Baseline and mUFC >ULN) at the Completion Visit | Up to 561 days |
| Part A and Part B: Late Night Salivary Cortisol (LNSC) Complete Response (Mean LNSC (mLNSC)≤ULN) or Partial Response (≥50% Reduction from Baseline in LNSC and mLNSC >ULN) at the End of the Titration Period and the Completion Visit | Up to 561 days |
| Recruiting |
| Angers |
| Cedex 09 |
| 49933 |
| France |
| Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception | Recruiting | Marseille | Europe | 13005 | France |
| Hopital Louis Pradel | Recruiting | Bron | 69677 | France |
| APHP - Hôpital Bicêtre | Recruiting | Le Kremlin-Bicêtre | 94275 | France |
| Centre Hospitalier Universitaire De Lille | Recruiting | Lille | 59000 | France |
| Hopital Haut-Leveque | Recruiting | Pessac | 33604 | France |
| Ltd Tbilisi Central Hospital | Recruiting | Tbilisi | Europe | 0159 | Georgia |
| National Institute of Endocrinology | Recruiting | Tbilisi | Europe | 0159 | Georgia |
| Multiprofile Clinic Consilium Medulla Ltd | Recruiting | Tbilisi | Europe | 0186 | Georgia |
| Ltd Aversi Clinic | Recruiting | Tbilisi | 160 | Georgia |
| Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika | Recruiting | Budapest | 1083 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Recruiting | Debrecen | 4032 | Hungary |
| University Hospital of Pecs | Recruiting | Pécs | 7624 | Hungary |
| Azienda Ospedale Università di Padova | Recruiting | Padova | Europe | 35128 | Italy |
| Azienda Ospedaliero-Universitaria Pisana | Recruiting | Pisa | Europe | 56124 | Italy |
| Università degli Studi di Messina - Azienda Ospedaliera Universitaria Policlinico 'Gaetano Martino' | Recruiting | Messina | Sicily | 98124 | Italy |
| Azienda Ospedaliera Universitaria Sant'Andrea | Recruiting | Rome | 00189 | Italy |
| AOU Citta della Salute e della Scienza di Torino | Recruiting | Torino | 10126 | Italy |
| University Hospital in Krakow | Recruiting | Krakow | 30-688 | Poland |
| Institutul National de Endocrinologie "C.I. Parhon" | Recruiting | Bucharest | 011863 | Romania |
| Spitalul Clinic Judetean de Urgenta Cluj-Napoca | Recruiting | Clju-Napoca | 400347 | Romania |
| Spitalul Clinic Judetean Mures | Recruiting | Mures | 540139 | Romania |
| Hospital de la Santa Creu i de Sant Pau | Recruiting | Barcelona | 08041 | Spain |
| Hospital Universitario Ramon y Cajal | Recruiting | Madrid | 28034 | Spain |
| Northern Care Alliance, North Manchester General Hospital | Recruiting | Manchester | Europe | M8 5RB | United Kingdom |
| University of Birmingham Institute of Metabolism and Systems Research | Recruiting | Birmingham | B15 2TT | United Kingdom |
| ID | Term |
|---|---|
| D047748 | Pituitary ACTH Hypersecretion |
| ID | Term |
|---|---|
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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