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Last Updated: June 30, 2022

CLINICAL TRIALS PROFILE FOR BARICITINIB


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505(b)(2) Clinical Trials for Baricitinib

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
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, JS–° 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 >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 >Phase >Start Date >Summary

Clinical Trial Conditions for Baricitinib

Condition Name

Condition Name for Baricitinib
Intervention Trials
Rheumatoid Arthritis 17
Healthy Volunteers 12
Atopic Dermatitis 9
Covid-19 8
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Condition MeSH

Condition MeSH for Baricitinib
Intervention Trials
Arthritis 22
COVID-19 19
Arthritis, Rheumatoid 19
Dermatitis 10
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Clinical Trial Locations for Baricitinib

Trials by Country

Trials by Country for Baricitinib
Location Trials
United States 545
Japan 154
Germany 91
United Kingdom 87
Mexico 67
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Trials by US State

Trials by US State for Baricitinib
Location Trials
Florida 28
California 25
Texas 25
New York 25
Pennsylvania 24
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Clinical Trial Progress for Baricitinib

Clinical Trial Phase

Clinical Trial Phase for Baricitinib
Clinical Trial Phase Trials
Phase 4 7
Phase 3 36
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for Baricitinib
Clinical Trial Phase Trials
Completed 39
Recruiting 27
Not yet recruiting 19
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Clinical Trial Sponsors for Baricitinib

Sponsor Name

Sponsor Name for Baricitinib
Sponsor Trials
Eli Lilly and Company 61
Incyte Corporation 20
National Institute of Allergy and Infectious Diseases (NIAID) 2
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Sponsor Type

Sponsor Type for Baricitinib
Sponsor Trials
Industry 92
Other 71
NIH 5
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