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 Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2017-11-17
Last Posted Date
2020-08-13
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
367
Registration Number
NCT03345914
Locations
🇬🇧

Regeneron Research Site, Sheffield, United Kingdom

Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis

First Posted Date
2017-09-26
Last Posted Date
2024-06-18
Lead Sponsor
University of California, San Francisco
Target Recruit Count
18
Registration Number
NCT03293030
Locations
🇺🇸

UCSF Psoriasis and Skin Treatment Center, San Francisco, California, United States

Study of REGN3500 and Dupilumab in Patients With Asthma

First Posted Date
2017-04-13
Last Posted Date
2020-01-18
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
32
Registration Number
NCT03112577
Locations
🇺🇸

WCCT Global, Cypress, California, United States

🇬🇧

Celerion, Belfast, United Kingdom

🇬🇧

Hammersmith Medicine Research, London, United Kingdom

and more 2 locations

Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis

First Posted Date
2017-02-15
Last Posted Date
2019-07-23
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
251
Registration Number
NCT03054428
Locations
🇨🇦

Regeneron Investigational Site, Windsor, Ontario, Canada

🇨🇦

Regeneron Research Site, Richmond Hill, Ontario, Canada

Study of Dupilumab Auto-injector Device When Used by Patients With Atopic Dermatitis

First Posted Date
2017-02-10
Last Posted Date
2018-08-01
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
176
Registration Number
NCT03050151
Locations
🇺🇸

Regeneron Investigational Site, Tacoma, Washington, United States

Dupilumab Compassionate Use Study

Conditions
First Posted Date
2017-01-13
Last Posted Date
2018-03-07
Lead Sponsor
Sally E. Wenzel MD
Registration Number
NCT03020810

Evaluation of Dupilumab in Children With Uncontrolled Asthma

First Posted Date
2016-10-31
Last Posted Date
2022-03-28
Lead Sponsor
Sanofi
Target Recruit Count
408
Registration Number
NCT02948959
Locations
🇺🇸

Investigational Site Number 840012, Tucson, Arizona, United States

🇺🇸

Investigational Site Number 840001, Rolling Hills Estates, California, United States

🇺🇸

Investigational Site Number 840016, Ann Arbor, Michigan, United States

and more 96 locations

A Study to Assess the Efficacy and Safety of Dupilumab in Participants With Severe Atopic Dermatitis (AD) That Are Not Controlled With Oral Cyclosporine A (CSA) or for Those Who Cannot Take Oral CSA Because it is Not Medically Advisable

Phase 3
Completed
Conditions
Interventions
First Posted Date
2016-04-29
Last Posted Date
2020-08-20
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
325
Registration Number
NCT02755649
Locations
🇩🇪

Site 7, Berlin, Germany

🇩🇪

Site 5, Berlin, Germany

🇬🇧

Site 1, London, United Kingdom

and more 4 locations

Open Label, Drug-Drug Interaction (DDI) Study of Dupilumab (REGN668/SAR231893) in Patients With Moderate to Severe Atopic Dermatitis (AD)

First Posted Date
2016-01-06
Last Posted Date
2016-08-22
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
14
Registration Number
NCT02647086
Locations
🇺🇸

Regeneron Study Site, Raleigh, North Carolina, United States

Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2015-11-23
Last Posted Date
2024-06-10
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
880
Registration Number
NCT02612454
Locations
🇬🇧

Regeneron Investigational Site, Sheffield, South Yorkshire, United Kingdom

🇩🇪

Regeneron Study Site, Muenchen, Germany

🇺🇸

Regeneron Investigational site, Philadelphia, Pennsylvania, United States

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