Clinical trials: Dupilumab
Lichen Simplex Chronicus
A Study to Investigate Improvement in Pruritus of Lichen Simplex Chronicus With Dupilumab Injections Compared With Placebo in Male and Female Participants Aged at Least 18 Years (STYLE 2)
This is a parallel, Phase 3, 2-arm study for treatment. The purpose of this study is to measure improvement in pruritus with dupilumab subcutaneous injections compared with placebo injections in male and female participants aged…
- Trial name
- NCT06687980
- Testing
- Dupilumab
- Where
- 63 sites in United States, Argentina and 15 more
- Volunteers
- 138 people
- Sponsor
- Sanofi
Type 2 Inflammatory Disorders
Compassionate Use or Expanded Access of Dupilumab
Provide Compassionate Use or Expanded Access of Dupilumab
- Trial name
- NCT04776694
- Testing
- Dupilumab
- Sponsor
- Regeneron Pharmaceuticals
Atopic Dermatitis (AD)
A Phase 1 Clinical Study Comparing GS101 and Dupixent® After Subcutaneous Injection
This is a randomized, double-blind, three-arm, parallel-group study designed to demonstrate the similarity of the pharmacokinetics (PK), safety, and immunogenicity of GS101 injection compared with U.S.
- Trial name
- NCT07411755
- Testing
- GS101 injection, U.S. commercial Dupixent®, CN commercial Dupixent®
- Where
- China
- Volunteers
- 294 people, healthy volunteers welcome
- Sponsor
- Jiangsu Genscend Biopharmaceutical Co., Ltd
Asthma
An Observational, Retrospective Multicentre Medical Record Review to Describe the Post-authorisation Early Clinical Experience of Dupilumab in the Treatment of Adult Severe Asthma
The purpose of this retrospective medical record review is to describe the real-world clinical effectiveness of dupilumab with patients in the United Kingdom with severe asthma.
- Trial name
- DUPIAZA (NCT06064526)
- Testing
- No intervention
- Where
- France
- Volunteers
- 144 people
- Sponsor
- Sanofi
Pruritus
Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)
The main objective of the study is to assess efficacy and safety of dupilumab given up to 24 weeks in adults with CPUO. This is a master protocol which includes 2 parallel-treatment, double-blind, 2- arm Phase 3 staggered studies…
- Trial name
- NCT05263206
- Testing
- Dupilumab, Fexofenadine (loratadine if not available)
- Where
- 94 sites in United States, Argentina and 11 more
- Volunteers
- 284 people
- Sponsor
- Sanofi
Eosinophilic Esophagitis (EoE)
A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis
This study is researching an experimental drug called dupilumab (called "study drug"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding…
- Trial name
- EoE-TOTs (NCT07112378)
- Testing
- dupilumab
- Where
- 13 sites in United States
- Volunteers
- 20 people
- Sponsor
- Regeneron Pharmaceuticals
Healthy Volunteers
A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chinese Volunteers
This study is a multicenter, randomized, double-masked, parallel-group, reference-drug-controlled clinical trial of IBI3027 in healthy male volunteers.
- Trial name
- NCT07502534
- Testing
- IBI3027, DUPIXENT® (dupilumab)
- Where
- China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Prurigo Nodularis
A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study. The study consists of 3 periods: Screening period: 2 to 4 weeks. Treatment period: 24 weeks. Post-intervention follow-up period: 16 weeks.
- Trial name
- NCT06293053
- Testing
- Dupilumab
- Where
- 15 sites in United States
- Volunteers
- 18 people
- Sponsor
- Sanofi
Atopic Dermatitis, Dermatitis Atopic
Dupilumab Skin BArrier Function and LIpidomics STudy in Atopic Dermatitis in China
This is a 16-week, open label, exploratory study designed to investigate dupilumab's effect on skin barrier function as measured by transepidermal water loss (TEWL) before and after skin tape stripping.
- Trial name
- BALISTAD-CN (NCT05624112)
- Testing
- Dupilumab
- Where
- China
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy
Safety, Tolerability and Pharmacokinetics of SAR231893 (REGN668) in Healthy Japanese Adult Male Subjects
Primary Objective: Assess the safety and tolerability of SAR231893 (REGN668) after ascending single subcutaneous (SC) doses in healthy Japanese adult male subjects Secondary Objectives: Assess the following parameters after…
- Trial name
- NCT01537653
- Testing
- SAR231893 (REGN668)
- Where
- Japan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Sanofi
Moderate-to-Severe Atopic Dermatitis, Dermatitis, Dermatitis Atopic
Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
The primary objective of the study was to demonstrate the efficacy of dupilumab as a monotherapy in participants ≥12 years to <18 years of age with moderate-to-severe atopic dermatitis (AD).
- Conditions
- Moderate-to-Severe Atopic Dermatitis, Dermatitis, Dermatitis Atopic, Eczema, Skin Diseases, Skin, Diseases Genetic, Genetic
- Trial name
- NCT03054428
- Testing
- Dupilumab
- Where
- 45 sites in United States, Canada
- Volunteers
- 251 people
- Sponsor
- Regeneron Pharmaceuticals
Atopic Dermatitis
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
The purpose of this study is to find out how well tilrekimig works, how safe it is, and how it affects the body in adults and adolescents with moderate to severe atopic dermatitis (eczema).
- Trial name
- Tilrek (NCT07783425)
- Testing
- Tilrekimig, Dupilumab
- Where
- 32 sites in United States, Japan
- Volunteers
- 1,375 people
- Sponsor
- Pfizer
Eosinophilic Gastritis (EoG), Eosinophilic Duodenitis (EoD)
A Study to Learn How Well Dupilumab Works in Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis and the Side Effects it May Have
This study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD).
- Conditions
- Eosinophilic Gastritis (EoG), Eosinophilic Duodenitis (EoD), Eosinophilic Gastrointestinal Disease (EGID), Eosinophilic Gastroenteritis
- Trial name
- ENGAGE (NCT05831176)
- Testing
- Dupilumab
- Where
- 53 sites in United States, Canada and 2 more
- Volunteers
- 22 people
- Sponsor
- Regeneron Pharmaceuticals
Nasal Polyps
An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis
Primary Objective: To evaluate the efficacy of dupilumab (SAR231893/REGN668) in the treatment of bilateral Nasal Polyposis (NP) by assessment of the endoscopic nasal polyp score (NPS) in comparison to placebo.
- Trial name
- NCT01920893
- Testing
- Dupilumab, Mometasone furoate nasal spray
- Where
- 14 sites in United States, Belgium and 2 more
- Volunteers
- 60 people
- Sponsor
- Sanofi
Dermatitis, Atopic
Study of Patients Receiving DUPIXENT® for Atopic Dermatitis (AD)
A long-term observational registry in patients with atopic dermatitis (AD) initiating treatment with DUPIXENT® (dupilumab)
- Trial name
- PROSE (NCT03428646)
- Testing
- Dupilumab
- Where
- 99 sites in United States, Canada
- Volunteers
- 858 people
- Sponsor
- Regeneron Pharmaceuticals
Atopic Dermatitis
Real-world Effectiveness Study of Long-term Treatment With Dupilumab in Participants ≥6 Years With Atopic Dermatitis
This is a Prospective, non-interventional (NIS) observational study in patients (≥6 years) with atopic dermatitis (AD) receiving dupilumab for the prospective evaluation of signs and symptoms, quality of life and disease control.
- Trial name
- PROTYPE2 (NCT06039241)
- Where
- 55 sites in Germany
- Volunteers
- 572 people
- Sponsor
- Sanofi
Chronic Rhinosinusitis With Nasal Polyps
Dupilumab in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyp (SINUS-M52)
This was a Phase 4, open-label, single-arm, multicenter study to evaluate the efficacy and safety of dupilumab subcutaneous (SC) injection monotherapy in Japanese participants aged 18 or older with CRSwNP that is not adequately…
- Trial name
- NCT05049122
- Testing
- Dupilumab SAR231893
- Where
- Japan
- Volunteers
- 25 people
- Sponsor
- Sanofi
Chronic Obstructive Pulmonary Disease
Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation
Primary Objective: To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by Annualized rate of acute moderate or severe COPD…
- Trial name
- NOTUS (NCT04456673)
- Testing
- Dupilumab SAR231893, Inhaled Corticosteroid, Inhaled Long-Acting Beta Agonist
- Where
- 334 sites in United States, Argentina and 27 more
- Volunteers
- 935 people
- Sponsor
- Sanofi
Atopic Dermatitis
A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants.
This is a randomised, double-blind, three-arm, parallel group, single-dose, Phase 1 comparative study of CKD-706, US-Dupixent, and EU-Dupixent in healthy adult participants.
- Trial name
- CKD-706 (NCT07358156)
- Testing
- CKD-706, US-Dupixent, EU-Dupixent
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 519 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Atopic Dermatitis
SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"
Primary Objective: To evaluate the effect of dupilumab on sleep quality in adult participants with moderate to severe atopic dermatitis (AD).
- Trial name
- NCT04033367
- Testing
- Dupilumab
- Where
- 42 sites in United States, Australia and 8 more
- Volunteers
- 188 people
- Sponsor
- Sanofi