총 15건

해외임상승인현황 정보 :: 순번, 임상시험 제목, 적응증, 연구설계, 의뢰자/실시기관, 임상단계, 게시일자
순번 임상시험 제목 적응증 연구설계 의뢰자/실시기관 임상단계 게시일자
1 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
2 Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676) High-risk Non-muscle Invasive Bladder Cancer Biological: Pembrolizumab|Biological: BCG Merck Sharp & Dohme Corp. Phase 3 2018-12-24
3 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
4 A Phase III Study of Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines Chronic Spontaneous Urticaria Biological: Ligelizumab|Biological: Omalizumab|Other: Placebo Novartis Pharmaceuticals|Novartis Phase 3 2018-10-17
5 An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1) Ulcerative Colitis Drug: Mirikizumab|Drug: Placebo Eli Lilly and Company Phase 3 2018-06-18
6 Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome Acute Coronary Syndrome Biological: Apolipoprotein A-I [human] (apoA-I)|Other: Placebo CSL Behring Phase 3 2018-03-21
7 A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy Ulcerative Colitis (UC) Drug: risankizumab IV|Drug: placebo for risankizumab|Drug: risankizumab SC AbbVie Phase 2|Phase 3 2018-03-07
8 Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients Migraine Biological: Erenumab|Other: Placebo Novartis Pharmaceuticals|Novartis Phase 3 2018-02-08
9 A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's Disease Drug: placebo for risankizumab IV|Drug: risankizumab SC|Drug: risankizumab IV AbbVie Phase 3 2018-01-03
10 A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s) Arthritis, Psoriatic Drug: Guselkumab|Drug: Placebo Janssen Research & Development, LLC Phase 3 2017-08-24