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). |
| NCT01490632 ↗ | A Phase 2b Study of Baricitinib in Participants With Moderate to Severe Psoriasis | Completed | Incyte Corporation | Phase 2 | 2011-12-01 | This is a dose-ranging study designed to investigate the efficacy and safety of Baricitinib in the treatment of participants with moderate to severe, chronic plaque psoriasis as assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety assessments. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for Baricitinib
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