Peripheral and penile angiography with iotrolan 280 versus non-ionic monomers: results of the European clinical phase II and III trials

1995 ◽  
Vol 5 (S2) ◽  
pp. S30-S38 ◽  
Author(s):  
J. K. Gmeinwieser ◽  
B. -I. Wenzel-Hora
Keyword(s):  
Phase Ii ◽  
Clinical Phase ◽  
Phase Ii And Iii

scholarly journals Clinical phase II and III studies of an AS03‐adjuvanted H5N1 influenza vaccine produced in an EB66 ® cell culture platform

2020 ◽  
Vol 14 (5) ◽  
pp. 551-563
Author(s):  
Masafumi Endo ◽  
Mitsuyoshi Tanishima ◽  
Kayo Ibaragi ◽  
Kenshi Hayashida ◽  
Tadashi Fukuda ◽  
...  
Keyword(s):  
Cell Culture ◽  
Influenza Vaccine ◽  
Phase Ii ◽  
Clinical Phase ◽  
H5n1 Influenza ◽  
Phase Ii And Iii

scholarly journals A Clinical Phase II Study to Assess Efficacy, Safety, and Tolerability of Waterfree Cyclosporine Formulation for Treatment of Dry Eye Disease

Ophthalmology ◽  
2019 ◽  
Vol 126 (6) ◽  
pp. 792-800 ◽  
Author(s):  
David L. Wirta ◽  
Gail L. Torkildsen ◽  
Helen R. Moreira ◽  
John D. Lonsdale ◽  
Joseph B. Ciolino ◽  
...  
Keyword(s):  
Phase Ii ◽  
Dry Eye ◽  
Phase Ii Study ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Clinical Phase

scholarly journals Ixabepilone-associated peripheral neuropathy: data from across the phase II and III clinical trials

2012 ◽  
Vol 20 (11) ◽  
pp. 2661-2668 ◽  
Author(s):  
Linda T. Vahdat ◽  
Eva S. Thomas ◽  
Henri H. Roché ◽  
Gabriel N. Hortobagyi ◽  
Joseph A. Sparano ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Peripheral Neuropathy ◽  
Phase Ii ◽  
Phase Ii And Iii

Telaprevir Versus Boceprevir in Chronic Hepatitis C: A Meta-Analysis of Data From Phase II and III Trials

2013 ◽  
Vol 35 (2) ◽  
pp. 190-197 ◽  
Author(s):  
Mugdha Sitole ◽  
Matthew Silva ◽  
Linda Spooner ◽  
Morgan K. Comee ◽  
Michael Malloy
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Chronic Hepatitis C ◽  
Phase Ii ◽  
Meta Analysis ◽  
Phase Ii And Iii

Tildrakizumab: A Review of Phase II and III Clinical Trials

2018 ◽  
Vol 53 (4) ◽  
pp. 413-418 ◽  
Author(s):  
Sree S. Kolli ◽  
Sarah D. Gabros ◽  
Adrian Pona ◽  
Abigail Cline ◽  
Steven R. Feldman
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Biological Therapy ◽  
Common Adverse Effect ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Severe Psoriasis ◽  
Phase Iii ◽  
Physician Global Assessment ◽  
Phase Ii And Iii

Objective: Tildrakizumab, an inhibitor of the p19 subunit of interleukin (IL)-23, was recently Food and Drug Administration (FDA) approved for patients with moderate to severe psoriasis. This article will review the phase II and III clinical trial data of tildrakizumab. Data Sources: A PubMed search from January 2000 to September 2018 was done with the search terms tildrakizumab, guselkumab, risankizumab, p19, interleukin-23, and psoriasis. Study Selection and Data Extraction: Articles discussing phase II and III clinical trial data for tildrakizumab were selected. Data Synthesis: In phase II and phase III trials, tildrakizumab was safe and efficacious compared with placebo and etanercept. More patients achieved Psoriasis Area and Severity Index 75 receiving tildrakizumab (200 mg, 62%-74%; 100 mg, 61%-66%; 25 mg, 64%; 5 mg, 33%) compared with placebo (4%-6%, P < 0.0001) and etanercept (48%, P = 0.01). More patients achieved Physician Global Assessment (PGA) response of “clear” or “minimal” receiving tildrakizumab (200 mg, 59%; 100 mg, 55%-58%) than the placebo group (4%-7%, P < 0.0001). 59% of patients who received tildrakizumab 200 mg achieved a PGA response of “clear” or “minimal” compared with etanercept (48%, P = 0.0031). The most common adverse effect was infection. Relevance to Patient Care and Clinical Practice: Tildrakizumab is a new, FDA-approved, physician-administered biological therapy for patients with moderate to severe psoriasis. It appears to be efficacious and safe so far. Conclusion: Tildrakizumab is efficacious and safe for the treatment of patients with moderate to severe psoriasis. IL-23/p19 inhibitors are a promising class of biological therapy.

Biomarker-Based Phase II and III Clinical Trials in Oncology

2019 ◽  
pp. 261-284
Author(s):  
Shigeyuki Matsui ◽  
Masataka Igeta ◽  
Kiichiro Toyoizumi
Keyword(s):  
Clinical Trials ◽  
Phase Ii ◽  
Phase Ii And Iii
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