Bratislava-stare Mesto, Slovakia
A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer
The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of BMS-986365 versus investigator's choice comprising Docetaxel + Prednisone/Prednisolone or Abiraterone + Prednisone/Prednisolone or Enzalutamide. In Part 1, participants will be randomized 1:1:1 to one of the two BMS-986365 dose levels, or to the active comparator arm (investigator's choice). In Part 2 of the study, participants will be randomized 1:1 between BMS-986365 selected dose, or to the active comparator arm (investigator's choice).
Phase
3Span
202 weeksSponsor
CelgeneBratislava
Recruiting
A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
This is a global, multicenter, randomized Phase 3 study evaluating PF-06821497 (mevrometostat) in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCRPC where no systemic anti-cancer treatments have been initiated after documentation of mCRPC with the exception of ADT (androgen deprivation therapy) and first-generation anti-androgen agents. Prior treatment with any of the ARSi's enzalutamide, darolutamide, apalutamide, or abiraterone acetate, is not permitted in any setting. Chemotherapy is permitted in the castrate sensitive setting. This study consists of a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. Participants will be randomized on a 1:1 basis to receive (Arm A) PF-06821497 in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.
Phase
3Span
215 weeksSponsor
PfizerBratislava
Recruiting
Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio
The study will consist of a screening period, a treatment and assessment period and an End of Study visit. Eligibility for the study will be determined during a screening period. Subjects who meet the eligibility criteria will be randomised to either AVT16 or Entyvio.
Phase
3Span
101 weeksSponsor
Alvotech Swiss AGBratislava
Recruiting
Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.
This is a Phase IIb, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in adults with type 2 diabetes mellitus, compared to placebo and active comparator. The study is planned to be conducted in approximately 15 countries, approximately 90 sites will be involved.
Phase
2Span
65 weeksSponsor
AstraZenecaBratislava
Recruiting
DORAYA-HF OUS Assessment of the Doraya Catheter for the Treatment of ADHF Patients With Insufficient Response to Diuretics
Phase
N/ASpan
96 weeksSponsor
Revamp Medical Ltd.Bratislava
Recruiting
Bratislava
Recruiting
Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer
This is a prospective, interventional, clinical study with in 2 cohorts. Target of subjects is 50 per cohort and an anticipated total duration of 36 months. Participants will undergo 4 sessions of HRV BI with the trainer where they will learn about the prognostic role of the vagal nerve in cancer and in reducing distress and pain, and how to perform deep paced breathing with the HRV monitoring. They will perform the training daily (3-times, minimum 7 minutes each) at home with the online control for 3 months. Researchers will compare the effect of addition of 3-months training of HRV BI to SOC on inflammation, HRV, quality of life (QoL), cognitive functions, salivary cortisol slopes, sleep quality and treatment outcomes of patients with colorectal and breast cancer.
Phase
N/ASpan
261 weeksSponsor
Comenius UniversityBratislava
Recruiting
Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine
Phase
3Span
88 weeksSponsor
AbbVieBratislava
Recruiting
A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of induction therapy with 2 active dose regimens of MORF-057 versus matching placebo in adult study participants with moderately to severely active CD. After completion of the 14-week Induction Period, all participants will receive open-label MORF-057 during the 38-week Maintenance Period. All participants who complete the full 52-week Treatment Period will also have the opportunity to continue treatment in a 52-week Maintenance Extension.
Phase
2Span
222 weeksSponsor
Morphic Therapeutic, IncBratislava
Recruiting
A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease
The drug being tested in this study is TAK-279. TAK-279 is being tested to treat participants with moderately to severely active Crohn's disease. The study will look at the efficacy and safety of TAK-279. The study will enroll approximately 268 participants. During the Induction Period participants will be randomly assigned to one of the following treatment groups in a ratio of 1:1:1:1 to receive TAK-279 or placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): 1. TAK-279 Dose 1 2. TAK-279 Dose 2 3. TAK-279 Dose 3 4. Placebo This multi-center trial will be conducted globally. The overall study duration is approximately 60 weeks including a 4-week safety follow-up period.
Phase
2Span
177 weeksSponsor
TakedaBratislava
Recruiting