Phase
Condition
Cushing's Disease
Treatment
Lu AG13909
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The participant is a man or woman with a confirmed diagnosis of adrenocorticotropichormone (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. inferiorpetrosal sinus gradient >2, or iii. histopathology confirmation of ACTH-secretingtumour
The participant has a 24-hour UFC >1.5 × ULN (the mean of ≥3 days of 24-hour urinecollection).
Apart from CD and associated well-controlled comorbidities (for example, diabetesmellitus and hypertension), the participant is generally healthy in the opinion ofthe 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-definedwashout periods must be completed prior to the Baseline efficacy assessments.
Exclusion
Exclusion Criteria:
The participant is pregnant, breastfeeding, intends to become pregnant, or is ofchild-bearing potential and not willing to use adequate contraceptive methods.
The participant has a clinically significant abnormal laboratory value, ECGparameter, vital signs value, or other safety findings at the Screening Visit thatindicate a potential risk to the participant's safety if enrolled, in the opinion ofthe investigator.
The participant has a history of known hypersensitivity or intolerance to Lu AG13909or its excipients.
The participant has immediate need for pituitary surgery within 6 months fromscreening in the opinion of the investigator.
The participant has severe CD per investigator judgement; among others, this couldbe participants with: i. poorly controlled hypertension ii. poorly controlled diabetes mellitus iii.severe psychiatric illness iv. compression of the optic chiasm causing any visualfield 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.
Study Design
Study Description
Connect with a study center
Centre Hospitalier Universitaire d'Angers
Angers 3037656, Cedex 09 49933
FranceActive - Recruiting
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception
Marseille 2995469, Europe 13005
FranceActive - Recruiting
Hopital Louis Pradel
Bron, 69677
FranceSite Not Available
Hopital Louis Pradel
Bron 3029931, 69677
FranceActive - Recruiting
APHP - Hôpital Bicêtre
Le Kremlin Bicêtre, 94275
FranceSite Not Available
APHP - Hôpital Bicêtre
Le Kremlin-Bicêtre 3003737, 94275
FranceActive - Recruiting
Centre Hospitalier Universitaire De Lille
Lille, 59000
FranceSite Not Available
Centre Hospitalier Universitaire De Lille
Lille 2998324, 59000
FranceActive - Recruiting
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception
Marseille, 13005
FranceSite Not Available
Hopital Haut-Leveque
Pessac, 33604
FranceSite Not Available
Hopital Haut-Leveque
Pessac 2987805, 33604
FranceActive - Recruiting
Ltd 'Multiprofile Clinic Consilium Medulla'
Tbilisi 611717, Europe 0186
GeorgiaActive - Recruiting
Ltd Tbilisi Central Hospital
Tbilisi 611717, Europe 0159
GeorgiaActive - Recruiting
Multiprofile Clinic Consilium Medulla Ltd
Tbilisi 611717, Europe 0186
GeorgiaActive - Recruiting
National Institute of Endocrinology
Tbilisi 611717, Europe 0159
GeorgiaActive - Recruiting
Aversi Clinic
Tbilisi, 160
GeorgiaActive - Recruiting
Ltd 'Multiprofile Clinic Consilium Medulla'
Tbilisi, 0186
GeorgiaSite Not Available
Ltd Aversi Clinic
Tbilisi, 160
GeorgiaActive - Recruiting
Ltd Tbilisi Central Hospital
Tbilisi, 0159
GeorgiaActive - Recruiting
Multiprofile Clinic Consilium Medulla
Tbilisi, 0186
GeorgiaActive - Recruiting
National Institute of Endocrinology
Tbilisi, 0159
GeorgiaActive - Recruiting
Tbilisi Central Hospital
Tbilisi, 0159
GeorgiaActive - Recruiting
Ltd Aversi Clinic
Tbilisi 611717, 160
GeorgiaActive - Recruiting
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
Budapest, 1083
HungarySite Not Available
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
Budapest 3054643, 1083
HungaryActive - Recruiting
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
HungarySite Not Available
Debreceni Egyetem Klinikai Kozpont
Debrecen 721472, 4032
HungaryActive - Recruiting
University Hospital of Pecs
Pécs, 7624
HungarySite Not Available
University Hospital of Pecs
Pécs 3046526, 7624
HungaryActive - Recruiting
Azienda Ospedale Università di Padova
Padua 3171728, Europe 35128
ItalyActive - Recruiting
Azienda Ospedaliero-Universitaria Pisana
Pisa 3170647, Europe 56124
ItalyActive - Recruiting
AOU Policlinico G. Martino
Messina 2524170, 98124
ItalyActive - Recruiting
Azienda Ospedaliero-Universitaria Pisana
Pisa, 56124
ItalySite Not Available
Azienda Ospedaliera Universitaria Sant'Andrea
Rome, 00189
ItalySite Not Available
Azienda Ospedaliera Universitaria Sant'Andrea
Rome 3169070, 00189
ItalyActive - Recruiting
AOU Citta della Salute e della Scienza di Torino
Torino, 10126
ItalySite Not Available
AOU Città della Salute e della Scienza di Torino
Torino, 10126
ItalyActive - Recruiting
AOU Citta della Salute e della Scienza di Torino
Torino 8980539, 10126
ItalyActive - Recruiting
Institutul National de Endocrinologie "C.I. Parhon"
Bucharest, 011863
RomaniaSite Not Available
Institutul National de Endocrinologie "C.I. Parhon"
Bucharest 683506, 011863
RomaniaActive - Recruiting
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Clju-Napoca, 400347
RomaniaActive - Recruiting
Spitalul Clinic Judetean Mures
Mures, 540139
RomaniaActive - Recruiting
Hospital de la Santa Creu i de Sant Pau
Barcelona, 08041
SpainSite Not Available
Hospital de la Santa Creu i de Sant Pau
Barcelona 3128760, 08041
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainSite Not Available
Hospital Universitario Ramon y Cajal
Madrid 3117735, 28034
SpainActive - Recruiting
Northern Care Alliance, North Manchester General Hospital
Manchester 2643123, Europe M8 5RB
United KingdomActive - Recruiting
University of Birmingham Institute of Metabolism and Systems Research
Birmingham 2655603,
United KingdomActive - Recruiting
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
United StatesActive - Recruiting

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