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NCT05763121
This study will assess the efficacy and safety of dexpramipexole as an adjunctive oral therapy in participants with inadequately controlled asthma with an eosinophilic phenotype and a history of asthma exacerbations.
NCT07051252
The purpose of this study is to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy.
NCT05085366
The main purpose of this study is to evaluate the efficacy of mRNA 1647 vaccine in CMV-seronegative female participants and to evaluate the safety and reactogenicity of mRNA-1647 vaccine in all participants. The purpose of the Phase 3 extension substudy is to extend the observation period of the main study and to assess the longer-term immunogenicity, efficacy, and safety of the mRNA-1647 vaccine against primary CMV infection in healthy females who were CMV-seronegative at Baseline of the mRNA-1647-P301 main study (including participants who remain CMV-seronegative upon entry into the extension substudy and participants who seroconverted during the main study). The extension substudy will also evaluate the immune persistence and safety of mRNA-1647 in a subset of female participants who were CMV-seropositive at Baseline of the main study. No interventional vaccine will be administered in the extension substudy.
NCT05040360
This phase II trial studies the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pancreatic neuroendocrine tumors.
NCT06558279
The purpose of this study is to evaluate the efficacy and safety of efgartigimod PH20 SC given by a pre-filled syringe in adult patients with ocular myasthenia gravis. The study consists of a part A (approximately 7 weeks) and a part B (up to 2 years). In part A, half of the participants will receive efgartigimod PH20 SC and the other half will receive placebo. In part B, all participants will receive efgartigimod PH20 SC. The participants will be in the study for about up to 2 years and 12 weeks.
NCT06685692
A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Moderate Alcohol Associated Hepatitis (Part 1)
NCT03919162
This is a Phase 2A multi-center, randomized, double blind, placebo-controlled, parallel group study of varoglutamstat, with a stage gate to Phase 2B. In Phase 2A there will be adaptive dosing evaluation of three dose levels with exposure to varoglutamstat or placebo for a minimum of 24 weeks, with preliminary evaluation of both cognitive function and pharmacodynamic changes on EEG spectral analysis in approximately 180 participants. In the event that the stage gate for Phase 2B is reached, then Phase 2B will assesses efficacy and longer-term safety in a larger study group, i.e., 414.
NCT05392114
The purpose of this study is to evaluate the long-term safety and efficacy of donidalorsen in people with HAE and the effects of donidalorsen on the number of HAE attacks and their impact on quality of life (QoL).
NCT05111626
The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab. The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.
NCT05478252
The study compares two semaglutide medicines and looks at how well they control blood sugar levels, in participants with type 2 diabetes (T2D). Participants will either get the currently available semaglutide or the semaglutide which is produced through a new manufacturing process. Participants need to take one injection of semaglutide once a week, on the same day of every week. Participants will have a total of 11 clinic visits and the study will last for about 35 weeks (approximately 8 months).
NCT07011667
This study will look at how well CagriSema helps people living with obesity to lose weight and maintain the weight loss long-term. The study has 2 parts: The first part is called 'the main study' and the second part is called 'the extension study'. In the main study participants will either get CagriSema (a study medicine) or placebo (a dummy medicine that looks like CagriSema but has no active ingredient). Which treatment participants get is decided by chance. Participants are two times more likely to get CagriSema than placebo. If participants get CagriSema in the main study, participants will continue on CagriSema in the extension study. Which dose of CagriSema participants will continue on is decided by chance. If participants get placebo in the main study, participants will get CagriSema in the extension study. Participants will take one injection of study medicine once a week. The study will last for about 3 years and 3 months.
NCT04722887
The purpose of this study is to evaluate the safety and tolerability of 72 milligrams per kilogram (mg/kg) and 180 mg/kg Alpha-1 15%, administered as a single-dose subcutaneous (SC) infusion and subsequently as weekly SC infusions over 8 weeks in participants with Alpha1-Antitrypsin Deficiency (AATD).
NCT05185843
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) effects of olezarsen (formerly known as AKCEA -APOCIII-LRX) in participants with FCS previously treated with volanesorsen.
NCT06937177
This is a randomized, double-blind, placebo-controlled study of B07, administered daily by subcutaneous (SC) injection, in up to 120 patients with newly diagnosed metastatic colorectal cancer. This study will evaluate different doses of B07 on weight, body composition and BMI in patients with sub-optimal BMIs (≤ 29 kg/m\^2). Treatment will start at the second cycle of first-line cancer chemotherapy and continue for 12-weeks with the goal of maintaining body weight and muscle mass in patients undergoing chemotherapy relative to control.
NCT05852938
Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy
NCT05611671
This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adult patients with moderately to severely active Ulcerative Colitis (UC).
NCT06768671
This is a study to evaluate the pharmacokinetic (PK) and safety of sonelokimab in adolescent patients with HS.
NCT04949256
The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma. The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). As of Amendment 09, Study MK-7902-014 will begin close out activities. Any participant who discontinues study intervention for any reason will be discontinued from the study without further follow-up. Second Course and treatment beyond disease progression will no longer be offered. No safety concerns contributed to the termination of this study.
NCT06730750
This is a study of BMS-986490 as a monotherapy and in combination with bevacizumab in participants with select advanced solid tumors known to express CEACAM5.
NCT05885022
To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma.