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Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
Expand descriptionThis is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.
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Retro-prospective Study of Safety & Performance of Round XTENDOBUTTON™ Fixation Device Post Knee Repair
Expand descriptionThe 12 month post-operative study is designed to provide safety and performance data on the Round XTENDOBUTTON™ fixation device after knee repair.
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A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer
Expand descriptionThe reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.
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Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
Expand descriptionThe purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878).
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Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-HZ in Healthy Adult Volunteers
Expand descriptionThis is a Phase 1, first in human (FIH), randomised, active-controlled, double-blind study designed to assess the safety and tolerability and explore preliminary efficacy of the EG-HZ vaccine. Oversight will be provided by a Safety Review Committee (SRC).
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Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)
Expand descriptionA multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.
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Study of APG-1252 Plus Paclitaxel in Patients With Relapsed/Refractory Small Cell Lung Cancer
Expand descriptionThis is a multi-center, open-label, phase Ib/II study of combination therapy with APG-1252 plus paclitaxel in patients with relapsed/refractory small-cell lung cancer(SCLC). The phase Ib portion will be done using time-to-event continual reassessment method (TITE-CRM) methodology to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of APG-1252 with a fixed dose of paclitaxel. The phase II portion will utilize a Simon two-stage design to determine the efficacy of the combination therapy with response rate as the primary endpoint.
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A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRa) Expression
Expand descriptionThis Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine (MIRV) vs. IC chemotherapy in participants with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRa. Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. The FRa positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.
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A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer
Expand descriptionThe purpose of the study is to see if treatment with nivolumab plus bempegaldesleukin or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with high-risk urothelial cancer, including muscle-invasive bladder cancer who are not able to receive cisplatin chemotherapy.
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Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children
Expand descriptionInternational registry to collect prospective treatment and outcomes data on specific, key non-pathological fractures in children with open physes. Data will be collected during follow-up visits according to standard of care at 3 to 8 weeks, 3, 6, 12 and 24 months