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ICoN-1: A Randomized Double-Blind Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101 (Clofazimine Inhalation Suspension) When Added to Guideline-Based Therapy in Participants with Pulmonary Nontuberculous Mycobacterial Infection (Part A) Followed by an Open-Label Extension (Part B)
The purpose of this clinical trial is to study if Clofazimine Inhalation Suspension can help treat people with non-tuberculous mycobacterium (NTM) lung disease versus placebo ...Phase
Interventional
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A PHASE III MULTICENTER RANDOMIZED OPEN-LABEL STUDY COMPARING THE EFFICACY AND SAFETY OF GLOFITAMAB (RO7082859) IN COMBINATION WITH POLATUZUMAB VEDOTIN PLUS RITUXIMAB CYCLOPHOSPHAMIDE DOXORUBICIN AND PREDNISONE (POLA-R-CHP) VERSUS POLA-R-CHP IN PREVIOUSLY UNTREATED PATIENTS WITH LARGE B-CELL LYMPHOMA
This study is to see which treatment (glofitamab in combination with Pola-R-CHP or Pola-R-CHP alone) works better for a large B-Cell Lymphoma. It involves patients ...
Phase
Interventional
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The RESTORATIVE303 Study: A Randomized Double-Blind Placebo-Controlled Phase 3 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection
The purpose of this research study is to see if the study drug, VE303, compared with placebo is safe and effective in preventing patients from ...Phase
Interventional
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A Phase 3 Randomized Double-Blind Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
The purpose of this study is to evaluate the safety and efficacy (how well something works) of EFX in people with NASH/MASH. NASH/MASH ...Phase
Interventional
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The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living with Obesity
The purpose of this study is to test if the investigational medicine (a medicine being studied) may help reduce the risk for heart disease and ...Phase
Interventional
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A Phase 3 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sj gren s Syndrome With Moderate-to-severe Systemic Disease Activity
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of a study drug called dazodalibep (also known as VIB4920) in participants ...Phase
Interventional
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Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Participants with Cholestatic Pruritus (EXPAND)
The purpose of this clinical research study is to learn more about the use of the study drug, maralixibat, for the treatment of cholestatic pruritus ...Phase
Interventional
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A Phase 3 randomized open-label multicenter controlled study to evaluate the efficacy and safety of zanidatamab in combination with physician s choice chemotherapy compared to trastuzumab in combination with physician s choice chemotherapy for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on or are intolerant to previous trastuzumab deruxtecan treatment
This study tests a new treatment called zanidatamab against a standard treatment called trastuzumab. Both treatments will be given with chemotherapy chosen by the doctor ...
Phase
Interventional
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An open-label randomized trial of zanidatamab with standard-of-care therapy against standard-of-care therapy alone for advanced HER2-positive biliary tract cancer (BTC)
This study is testing a new treatment called zanidatamab to see how well it works and how safe it is for people with a type ...
Phase
Interventional
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A Phase 3 Single-arm Multicenter Study to Evaluate the Efficacy and Safety of UGN-103 a Novel Formulation of UGN-102 for the Treatment of Patients With Low Grade (LG) Nonmuscle Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence (UTOPIA)
This study will test how well UGN-103, a new form of UGN-102, works and how safe it is for patients with low-grade bladder cancer (LG ...
Phase
Interventional
