A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing's disease
This Study is
No Longer Enrolling
This study is a clinical research study consisting of 2 different periods (in the Core phase) with a total expected duration of 48 weeks and the first 12 weeks being a double-blind placebo controlled portion and then 36 weeks of study drug treament, followed by an optional extension phase for an additional 52 weeks (in which case the total duration of study participation will be up to 100 weeks). It is sponsored by the pharmaceutical company named Novartis (the ?Sponsor?). Around 69 patients will join this study in approximately 35 centers located in different countries (around 12) across the world. The purpose of this study is to confirm the effectiveness and safety of osilodrostat in treating patients with Cushing's Disease.
MoreAdult
Males and Females Ages 18-75 Key inclusion criteria: ?Confirmed CD that is persistent or recurrent as evidenced by all of the following criteria being met (i.e., a, b and c): 1.mUFC > 1.3 x ULN (Mean of three 24-hour urine samples collected preferably on 3 consecutive days, during screening after washout of prior medical therapy for CD (if applicable), confirmed by the central laboratory and available before Day 1), with ≥2 of the individual UFC values being > 1.3 x ULN. 2.Morning plasma ACTH above Lower Limit of Normal 3.Confirmation (based on medical history) of pituitary source of excess ACTH as defined by any one or more of the following three criteria: i. Histopathologic confirmation of an ACTH-staining adenoma in patients who have had prior pituitary surgery. OR ii. MRI confirmation of pituitary adenoma > 6 mm OR iii. Bilateral inferior petrosal sinus sampling (BIPSS) with either CRH or DDAVP stimulation for patients with a tumor ≤ 6mm. The criteria for a confirmatory BIPSS test are any of the following: Pre-dose central to peripheral ACTH gradient > 2; Post-dose central to peripheral ACTH gradient > 3 after either CRH or DDAVP stimulation ?Patients that received glucocorticoid replacement therapy must have discontinued such therapy for at least seven days or 5 half-lives prior to screening, whichever is longer. ?Patients with de novo CD can be included only if they are not considered candidates for surgery (e.g., poor surgical candidates due to co-morbidities, inoperable tumors, patients who refuse to have surgical treatment, or surgical treatment is not available).
For detailed information, visit ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT02697734
III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
Treatment
University of Colorado Hospital
Protocol Number: 17-0483
More information available at ClinicalTrials.gov: NCT02697734
Not finding the right Study for you? Join ResearchMatch, a nation-wide registry connecting volunteers and researchers