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해외임상승인현황 정보 :: 순번, 임상시험 제목, 적응증, 연구설계, 의뢰자/실시기관, 임상단계, 게시일자
순번 임상시험 제목 적응증 연구설계 의뢰자/실시기관 임상단계 게시일자
1 The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients HIV-1 Infection Biological: UB-421(25 mg/kg) Q2W|Biological: UB-421(25 mg/kg) Q4W United BioPharma|National Taiwan University Hospital|Taipei Veterans General Hospital, Taiwan|Taoyuan General Hospital|Kaohsiung Medical University Chung-Ho Memorial Hospital|Kaohsiung Veterans General Hospital. Phase 2 2019-08-01
2 Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients Urticaria Chronic Biological: UB-221 United BioPharma Phase 1 2019-04-08
3 A Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy Psoriatic Arthritis Biological: placebo for rizankizumab|Biological: risankizumab AbbVie Phase 3 2019-03-25
4 Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma Asthma Biological: Tezepelumab|Other: Placebo AstraZeneca|Amgen Phase 3 2019-01-07
5 Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002) Carcinoma, Hepatocellular Drug: lenvatinib|Biological: pembrolizumab|Drug: saline placebo Merck Sharp & Dohme Corp.|Eisai Inc. Phase 3 2018-12-31
6 Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS Relapsing Multiple Sclerosis Biological: Ofatumumab|Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap)|Biological: 13-valent pneumococcal conjugate vaccine (13-PCV)|Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV)|Biological: Seasonal Quadrivalent influenza vaccine|Biological: Keyhole limpet hemocyanin (KLH) neo-antigen Novartis Pharmaceuticals|Novartis Phase 3 2018-12-28
7 Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756) Breast Cancer Biological: Pembrolizumab (K)|Drug: Placebo (P)|Drug: Paclitaxel (X)|Drug: Doxorubicin hydrochloride (A)|Drug: Epirubicin (E)|Drug: Cyclophosphamide (C)|Drug: Endocrine therapy|Radiation: Radiation therapy|Procedure: Surgery Merck Sharp & Dohme Corp. Phase 3 2018-12-27
8 Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43) Ovarian Cancer|Fallopian Tube Cancer|Peritoneal Neoplasms Biological: Pembrolizumab|Drug: Placebo for pembrolizumab|Drug: Carboplatin|Drug: Paclitaxel|Drug: Olaparib|Drug: Placebo for olaparib|Biological: Bevacizumab Merck Sharp & Dohme Corp.|European Network for Gynaecological Oncological Trial Groups Phase 3 2018-12-18
9 Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689) Head and Neck Neoplasms Biological: Pembrolizumab 200 mg|Radiation: Radiotherapy 60 Gray/day|Radiation: Radiotherapy 66 Gray/day|Radiation: Radiotherapy 70 Gray/day|Drug: Cisplatin 100 mg/m^2 Merck Sharp & Dohme Corp. Phase 3 2018-12-17
10 A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13??in Healthy Infants (V114-031/PNEU-LINK) Pneumococcal Infections Biological: V114|Biological: Prevnar 13??Percentage of Participants with a Solicited Injection-site Adverse Event|Percentage of Participants with a Solicited Systemic Adverse Event|Percentage of Participants with a Vaccine-related Serious Adverse Event|Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) at 30 days after Dose 3|Geometric Mean Concentration of Serotype-specific IgG before Dose 4|Geometric Mean Concentration of Serotype-specific IgG at 30 Days after Dose 4|Percentage of Participants Meeting the Serotype-specific IgG Threshold of ??.35 쨉g/mL Merck Sharp & Dohme Corp. Phase 3 2018-12-14