Baricitinib

Generic Name: Baricitinib

Brand Names: Olumiant

Drug Type: Small Molecule

Chemical Formula: C_₁₆H_₁₇N_₇O_₂S

CAS Number: 1187594-09-7

Unique Ingredient Identifier: ISP4442I3Y

Background: Baricitinib is a Janus kinase (JAK) inhibitor. JAKs are tyrosine protein kinases that play an important role in pro-inflammatory signaling pathways. Overactive JAKs have been implicated in autoimmune disorders, such as rheumatoid arthritis. By inhibiting the actions of JAK1 and JAK2, baricitinib attenuates JAK-mediated inflammation and immune responses.

Baricitinib was first approved by the European Commission (EC) in February 2017 for the treatment of rheumatoid arthritis in adults and was later approved by the FDA in 2018. The EC later approved baricitinib for the treatment of atopic dermatitis, making it the first JAK inhibitor used for this indication in Europe. While baricitinib was granted emergency use as a treatment for COVID-19 in combination with remdesivir under the Emergency Use Authorization (EUA) in November 2020, the FDA fully approved the use of baricitinib for the treatment of COVID-19 in May 2022.

Indication: In the US and Europe, baricitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers. Baricitinib may be used as monotherapy or in combination with methotrexate or other DMARDs.

In Europe, baricitinib is indicated for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy.

In the US, baricitinib is also indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. Recently, it is also approved as the treatment for severe alopecia areata in adults.

Associated Conditions: Alopecia Areata (AA), Coronavirus Disease 2019 (COVID‑19), Severe Atopic Dermatitis, Moderate Atopic dermatitis, Moderate, active Rheumatoid arthritis, Severe, active Rheumatoid arthritis

Associated Therapies: -

Clinical Trials

Molecular Signatures in Inflammatory Skin Disease

Recruiting

Conditions: Atopic Dermatitis
Psoriasis

Interventions: Drug: Ustekinumab
Drug: Brodalumab
Drug: Ixekizumab
Drug: Baricitinib
Drug: Infliximab
Drug: Secukinumab
Drug: Dupilumab
Drug: Tralokinumab
Drug: Abrocitinib
Drug: Upadacitinib

First Posted Date: 2017-11-30

Last Posted Date: 2024-12-04

Lead Sponsor: Prof. Dr. Stephan Weidinger

Target Recruit Count: 300

Registration Number: NCT03358693

Locations: 🇩🇪
Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel, Kiel, Germany

A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis

Phase 3

Completed

Conditions: Atopic Dermatitis

Interventions: Drug: Baricitinib
Drug: Placebo

First Posted Date: 2017-11-07

Last Posted Date: 2023-07-21

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 1645

Registration Number: NCT03334435

Locations: 🇦🇺
Fremantle Dermatology, Perth, Western Australia, Australia
🇩🇪
Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg, Germany
🇭🇺
SZTE AOK Borgyogyaszati es Allergologiai Klinika, Szeged, Csongrad, Hungary

and more 181 locations

A Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis

Phase 3

Completed

Conditions: Atopic Dermatitis

Interventions: Drug: Baricitinib
Drug: Placebo

First Posted Date: 2017-11-07

Last Posted Date: 2020-08-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 660

Registration Number: NCT03334396

Locations: 🇲🇽
Hospital Univ. Dr. Jose Eleuterio Gonzalez, Monterrey, Nuevo León, Mexico
🇲🇽
RM Pharma Specialists S.A. de C.V., Distrito Federal, Mexico
🇨🇳
National Cheng Kung University Hospital, Tainan City, Taiwan

and more 89 locations

Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis

Phase 3

Completed

Conditions: Atopic Dermatitis

Interventions: Drug: Baricitinib
Drug: Placebo

First Posted Date: 2017-11-07

Last Posted Date: 2020-01-22

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 615

Registration Number: NCT03334422

Locations: 🇭🇺
Oroshaza Varosi Onkormanyzat Korhaza, Oroshaza, Hungary
🇯🇵
Nomura Dermatology Clinic, Yokohama-shi, Kanagawa, Japan
🇯🇵
Yamate Dermatological Clinic, Shinjuku, Tokyo, Japan

and more 77 locations

Baricitinib in Relapsing Giant Cell Arteritis

Phase 2

Completed

Conditions: Arteritis, Giant Cell

Interventions: Drug: Baricitinib

First Posted Date: 2017-01-20

Last Posted Date: 2022-04-08

Lead Sponsor: Matthew J Koster

Target Recruit Count: 15

Registration Number: NCT03026504

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

Study of Baricitinib, a JAK1/2 Inhibitor, in Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

Phase 1

Completed

Conditions: Chronic Graft-Versus-Host Disease
Chronic Graft vs Host Disease

Interventions: Drug: Baricitinib

First Posted Date: 2016-05-03

Last Posted Date: 2024-10-08

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 24

Registration Number: NCT02759731

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

A Study of Baricitinib (LY3009104) in Healthy Chinese Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Placebo
Drug: Baricitinib

First Posted Date: 2016-05-02

Last Posted Date: 2017-12-07

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 33

Registration Number: NCT02758613

Locations: 🇨🇳
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician., Beijing, China

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Phase 3

Recruiting

Conditions: Community-acquired Pneumonia, Influenza, COVID-19

Interventions: Other: No systemic corticosteroid
Other: No antiviral agent for COVID-19
Other: No immune modulation for COVID-19
Drug: Standard course macrolide
Other: No antiviral agent for influenza
Drug: Local standard venous thromboprophylaxis
Other: No immunoglobulin
Other: No simvastatin
Other: No cysteamine
Other: No Immune Modulator for Influenza
Other: No vitamin C
Other: No antiplatelet
Procedure: Clinician-preferred mechanical ventilation strategy
Other: No renin-angiotensin system inhibitor
Other: No endothelial modulator
Drug: Ceftriaxone
Drug: Eritoran
Drug: Moxifloxacin or Levofloxacin
Drug: Fixed-duration Hydrocortisone
Drug: Extended course macrolide
Drug: Five-days oseltamivir
Drug: Lopinavir / Ritonavir
Biological: Convalescent plasma
Drug: Angiotensin converting enzyme inhibitor
Drug: Nirmatrelvir/ritonavir
Drug: Therapeutic dose anticoagulation
Procedure: Protocolised mechanical ventilation strategy
Drug: Interferon beta-1a
Drug: Vitamin C
Drug: Simvastatin
Drug: Aspirin
Drug: Cysteamine
Drug: Imatinib
Drug: Angiotensin Receptor Blockers
Drug: Shock-dependent hydrocortisone
Drug: Ten-days oseltamivir
Drug: P2Y12 inhibitor
Drug: Conventional low dose thromboprophylaxis
Biological: Delayed administration of convalescent plasma
Drug: Piperacillin-tazobactam
Drug: Hydroxychloroquine
Drug: Anakinra
Drug: Apremilast
Drug: Baricitinib
Drug: Remdesivir
Drug: Hydroxychloroquine + lopinavir/ritonavir
Drug: Nirmatrelvir/ritonavir + remdesivir
Drug: Fixed-duration higher dose Hydrocortisone
Drug: Intermediate dose thromboprophylaxis
Drug: ARB + DMX-200
Drug: Ceftaroline
Drug: Baloxavir Marboxil
Drug: Tocilizumab
Drug: Fixed-duration dexamethasone
Drug: Amoxicillin-clavulanate
Drug: Five-days oseltamivir + baloxavir marboxil
Drug: Continuation of therapeutic dose anticoagulation
Drug: Ivermectin
Drug: Sarilumab
Drug: Ten-days oseltamivir + baloxavir marboxil

First Posted Date: 2016-04-13

Last Posted Date: 2024-07-12

Lead Sponsor: UMC Utrecht

Target Recruit Count: 20000

Registration Number: NCT02735707

Locations: 🇨🇦
Toronto Western Hospital, Toronto, Ontario, Canada
🇺🇸
University of Illinois Health, Chicago, Illinois, United States
🇦🇺
Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia

and more 405 locations

A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)

Phase 2

Completed

Conditions: Systemic Lupus Erythematosus

Interventions: Drug: Placebo
Drug: Baricitinib

First Posted Date: 2016-03-15

Last Posted Date: 2018-11-21

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 314

Registration Number: NCT02708095

Locations: 🇺🇸
The Ohio State University, Columbus, Ohio, United States
🇺🇸
University of Arizona, Tucson, Arizona, United States
🇨🇳
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Taipei, Taiwan

and more 29 locations

A Study of Baricitinib (LY3009104) in Participants With Moderate-to-Severe Atopic Dermatitis

Phase 2

Completed

Conditions: Atopic Dermatitis

Interventions: Drug: Placebo
Drug: Baricitinib
Drug: Triamcinolone (Optional)

First Posted Date: 2015-10-15

Last Posted Date: 2020-06-17

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 124

Registration Number: NCT02576938

Locations: 🇺🇸
Medical Dermatology Specialists, Atlanta, Georgia, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
Menter Dermatology Research Institute, Dallas, Texas, United States

and more 7 locations

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