CLINICAL TRIALS PROFILE FOR BARICITINIB
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505(b)(2) Clinical Trials for BARICITINIB
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Dosage | NCT05187793 ↗ | Randomized Study of Efficacy of Different Treatment Regimens of Olokizumab | Recruiting | Federal Budget Institution of Science "Central Research Institute of Epidemiology" of the Rospotrebnadzor | Phase 3 | 2021-07-08 | The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation. This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial. |
| New Dosage | NCT05187793 ↗ | Randomized Study of Efficacy of Different Treatment Regimens of Olokizumab | Recruiting | Group of companies Medsi, JSС | Phase 3 | 2021-07-08 | The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation. This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial. |
| New Dosage | NCT05187793 ↗ | Randomized Study of Efficacy of Different Treatment Regimens of Olokizumab | Recruiting | R-Pharm | Phase 3 | 2021-07-08 | The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation. This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for BARICITINIB
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00902486 ↗ | INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs | Completed | Incyte Corporation | Phase 2 | 2009-05-01 | This was a randomized, double blind, placebo controlled, dose ranging, parallel group study. Participants who had active rheumatoid arthritis (RA) who had inadequate response to any disease modifying anti-rheumatic drug (DMARD) therapy including biologics were enrolled. Screening evaluations were performed within approximately 28 days of randomization. The duration of the study was 6 months with the primary endpoint assessed at 3 months. Eligible participants were randomly assigned to one of three doses (4, 7 or 10 mg QD) of INCB028050 (Baricitinib) or placebo. |
| NCT01185353 ↗ | A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy | Completed | Incyte Corporation | Phase 2 | 2010-10-01 | The purpose of this trial is to evaluate the safety and efficacy of LY3009104 in participants with Rheumatoid Arthritis (RA). |
| NCT01185353 ↗ | A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy | Completed | Eli Lilly and Company | Phase 2 | 2010-10-01 | The purpose of this trial is to evaluate the safety and efficacy of LY3009104 in participants with Rheumatoid Arthritis (RA). |
| NCT01247350 ↗ | A Study of LY3009104(Baricitinib) for Healthy Subjects | Completed | Eli Lilly and Company | Phase 1 | 2010-11-01 | To evaluate the safety and tolerability of LY3009104 when given orally as single and multiple doses in Japanese healthy subjects. |
| NCT01299285 ↗ | Disposition of 14C-LY3009104 Following Oral Administration in Healthy Human Subjects | Completed | Eli Lilly and Company | Phase 1 | 2011-02-01 | This is a single dose study of radiolabeled [14C]-LY3009104 in healthy male volunteers to study the absorption, distribution, metabolism, and elimination of LY3009104. This study requires minimum of 7 days and maximum of 22 days stay. This study is for research purposes only and is not intended to treat any medical condition. |
| NCT01469013 ↗ | Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy | Completed | Eli Lilly and Company | Phase 2 | 2011-11-01 | This is a Phase 2b, outpatient, randomized, double-blinded (with a single-blind extension), placebo-controlled, dose-ranging, parallel-group study of baricitinib (LY3009104) in Japanese participants with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy. Baricitinib will be orally administered once a day with background methotrexate [6 to 16 milligrams (mg)/week] therapy for 12 weeks in the double-blind treatment period (1, 2, 4 or 8 mg/day, or placebo), and for 52 weeks in the single-blind extension period (4 or 8 mg/day). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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