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 1. the effect of Lu AG13909 on cortisol levels. 2. the safety and tolerability of Lu AG13909. 3. the pharmacokinetic parameters of Lu AG13909 (how the drug is absorbed, distributed, and processed by the body).
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 periods: a SC Titration Period, a Maintenance Period, and a Safety Follow-up Period * Extension Period, consisting of a Long-Term Efficacy/Safety Period after Part B and a Safety Follow-up Period
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Solution for injection/infusion
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
Time frame: Up to 490 days
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 1023 days
AUC0-tau,ss: Area Under the Plasma Concentration Curve of Lu AG13909 at Steady State
Time frame: Up to 1037 days
CL: Systemic Clearance of Lu AG13909
Time frame: Up to 1037 days
t½: Elimination Half-life of Lu AG13909
Time frame: Up to 1037 days
Vd: Apparent Volume of Distribution of Lu AG13909
Time frame: Up to 1037 days
SC Bioavailability (F) of Lu AG13909
Time frame: Up to 1037 days
Number of Participants With Anti-Drug Antibodies (ADAs)
Time frame: Up to 1037 days
Part A Only: Cmax: Maximum Observed Plasma Concentration of Lu AG13909
Time frame: Up to 323 days
Part A Only: Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Lu AG13909
Time frame: Up to 323 days
Part A & Part B: Ctrough: Minimum Observed Concentration of Lu AG13909
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University of Michigan Health-A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, United States
RECRUITINGWashington University School of Medicine in St. Louis
St Louis, Missouri, United States
RECRUITINGHospices Civils de Lyon (HCL) - Hopital Louis Pradel - Centre De Reference Maladie De Rendu-Osler
Bron, Auvergne-Rhône-Alpes, France
RECRUITINGCentre Hospitalier Universitaire de Lille (CHU Lille)
Lille, Hauts-de-France, France
RECRUITINGCentre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque
Pessac, New Aquitaine, France
RECRUITINGCentre Hospitalier Universitaire d'Angers - Centre de recherche clinique
Angers, Pays de la Loire Region, France
RECRUITINGAssistance Publique Hopitaux de Marseille (AP-HM) - Hopital de la Conception - Pole Psychiatrie C...
Marseille, Provence-Alpes-Côte d'Azur Region, France
RECRUITINGAPHP - Hôpital Bicêtre
Le Kremlin-Bicêtre, France
RECRUITINGAversi Clinic - Central Branch
Tbilisi, Europe, Georgia
RECRUITINGMultiprofile Clinic Consilium Medulla Ltd
Tbilisi, Europe, Georgia
RECRUITING...and 18 more locations
Time frame: Up to 659 days
Part A & Part B: Ttrough: Nominal Time Corresponding to the Occurrence of Ctrough
Time frame: 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
Time frame: Up to 491 days
Maintenance of UFC Complete Response (mUFC ≤ULN) at the End of the Part B Maintenance Period
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 561 days