Dupilumab

Generic Name
Dupilumab
Brand Names
Dupixent
Drug Type
Biotech
Chemical Formula
-
CAS Number
1190264-60-8
Unique Ingredient Identifier
420K487FSG
Background

Dupilumab is a fully human monoclonal antibody of the immunoglobulin G4 subclass that binds to the interleukin-4 (IL-4) receptor, inhibiting the receptor signaling pathways. As an interleukin-4 receptor alpha antagonist, dupilumab inhibits the signaling of pro-inflammatory cytokines, called interleukins (IL), that induce inflammatory and immunological reacti...

Indication

In the US, dupilumab is indicated for the treatment of patients aged six months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. In Europe and Canada, the drug for this indication is approved for patients aged six years and older. In E...

Associated Conditions
Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP), Eosinophilic Esophagitis, Moderate to Severe Asthma, Moderate to Severe Atopic Dermatitis, Oral Steroid-Dependent Asthma (Disorder), Prurigo Nodularis, Severe Asthma, Severe Atopic Dermatitis, Moderate Atopic dermatitis, Moderate Prurigo Nodularis, Severe Prurigo Nodularis
Associated Therapies
Add-on therapy, Maintenance therapy

Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)

First Posted Date
2013-11-08
Last Posted Date
2020-03-18
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
54
Registration Number
NCT01979016

Open-label Study of Dupilumab in Patients With Atopic Dermatitis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-09-24
Last Posted Date
2023-10-17
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
2733
Registration Number
NCT01949311
Locations
🇵🇱

Regeneron Study Site 5, Warszawa, Mazowieckie, Poland

🇪🇸

Regeneron Study Site 4, Barcelona, Spain

🇬🇧

Regeneron Study Site 1, London, United Kingdom

and more 6 locations

An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis

First Posted Date
2013-08-12
Last Posted Date
2017-06-26
Lead Sponsor
Sanofi
Target Recruit Count
60
Registration Number
NCT01920893
Locations
🇺🇸

Investigational Site Number 840013, Boston, Massachusetts, United States

🇺🇸

Investigational Site Number 840014, Rolling Hills Estates, California, United States

🇺🇸

Investigational Site Number 840015, Denver, Colorado, United States

and more 11 locations

Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Phase 2
Completed
Conditions
Interventions
First Posted Date
2013-05-22
Last Posted Date
2017-08-28
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
380
Registration Number
NCT01859988

An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

First Posted Date
2013-05-15
Last Posted Date
2017-06-26
Lead Sponsor
Sanofi
Target Recruit Count
776
Registration Number
NCT01854047
Locations
🇯🇵

Investigational Site Number 392024, Sakai-Shi, Japan

🇯🇵

Investigational Site Number 392003, Toride-Shi, Japan

🇯🇵

Investigational Site Number 392035, Yokohama-Shi, Japan

and more 198 locations

Study of Dupilumab in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis

Phase 2
Completed
Conditions
Interventions
First Posted Date
2012-03-08
Last Posted Date
2018-08-10
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
109
Registration Number
NCT01548404

Safety and Tolerability of Dupilumab in Participants With Moderate to Severe Atopic Dermatitis

First Posted Date
2011-06-30
Last Posted Date
2020-02-26
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
37
Registration Number
NCT01385657

Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma

First Posted Date
2011-03-11
Last Posted Date
2017-06-08
Lead Sponsor
Sanofi
Target Recruit Count
104
Registration Number
NCT01312961
Locations
🇺🇸

Investigational Site Number 840003, Minneapolis, Minnesota, United States

🇺🇸

Investigational Site Number 840006, Saint Louis, Missouri, United States

🇺🇸

Investigational Site Number 840047, Anaheim, California, United States

and more 47 locations
© Copyright 2024. All Rights Reserved by MedPath