Clinical trials: Dupilumab
Healthy Volunteers
Single Dose Comparability Study of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults
This is a parallel group, treatment, Phase 1, open-label, 2-arm study to demonstrate pharmacokinetic comparability between subcutaneous (SC) single dose of new dupilumab product and SC single dose of current dupilumab product in…
- Trial name
- NCT05976386
- Testing
- Dupilumab (SAR231893)
- Where
- United States
- Volunteers
- 182 people, healthy volunteers welcome
- Sponsor
- Sanofi
Atopic Dermatitis
Dupilumab Skin Barrier Function Study in Atopic Dermatitis
Primary Objective: Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after skin tape stripping (STS) in pre-defined lesional skin in participants with moderate to severe atopic dermatitis…
- Trial name
- BALISTAD (NCT04447417)
- Testing
- Dupilumab SAR231893
- Where
- 2 sites in United States, Canada
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Sanofi
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
Neurodermatitis
Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME)
Primary Objective: To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapies or when those therapies are not advisable.
- Trial name
- NCT04183335
- Testing
- Dupilumab SAR231893, Moisturizers, Low to medium potent topical corticosteroids
- Where
- 63 sites in United States, Argentina and 6 more
- Volunteers
- 151 people
- Sponsor
- Sanofi
Neurodermatitis
Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)
Primary Objective: To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapy or when those therapies are not advisable.
- Trial name
- NCT04202679
- Testing
- Dupilumab SAR231893, Moisturizers, Low to medium potent topical corticosteroids
- Where
- 57 sites in United States, Canada and 9 more
- Volunteers
- 160 people
- Sponsor
- Sanofi
Dermatitis Atopic
Dupilumab Effect on Pruritus Neuro-mechanisms in Patients With Atopic Dermatitis
Primary Objective: Assess change in neuronal architecture following long term treatment with dupilumab in skin biopsies from atopic dermatitis (AD) participants with chronic pruritus.
- Trial name
- DIFFEREN-STAD (NCT04823130)
- Testing
- Dupilumab (SAR231893)
- Where
- 3 sites in United States, Germany
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Sanofi
Dermatitis Atopic
Dupilumab-PEdiatric Skin Barrier Function and LIpidomics STudy in Patients With Atopic Dermatitis
Primary Objective: Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after skin tape stripping (STS) in predefined lesional skin in pediatric participants with moderate to severe atopic…
- Trial name
- PELISTAD (NCT04718870)
- Testing
- Dupilumab SAR231893
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 41 people, healthy volunteers welcome
- 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
Atopic Dermatitis
Dupilumab in Japanese Patients With Atopic Dermatitis
Primary Objective: To evaluate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) Secondary Objective: To evaluate the efficacy of dupilumab administered concomitantly with TCS.
- Trial name
- NCT04678882
- Testing
- Dupilumab SAR231893
- Where
- 19 sites in Japan
- Volunteers
- 62 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
Cold Urticaria
Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS)
Primary Objective: To demonstrate the efficacy of dupilumab in adult and adolescent participants with primary acquired chronic inducible cold urticaria (ColdU) who remain symptomatic despite the use of an H1-antihistamine…
- Trial name
- NCT04681729
- Testing
- Dupilumab SAR231893, Non sedating H1-antihistamine
- Where
- 33 sites in United States, Argentina and 3 more
- Volunteers
- 82 people
- Sponsor
- Sanofi
Asthma
The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma
Primary Objective: To assess the effect of dupilumab on lung inflammation and related changes in airway volumes detectable by functional respiratory imaging Secondary Objective: To evaluate the effect of dupilumab at Week 24 on…
- Trial name
- VESTIGE (NCT04400318)
- Testing
- Dupilumab
- Where
- 65 sites in United States, Bulgaria and 11 more
- Volunteers
- 109 people
- Sponsor
- Sanofi
Neterton Syndrome
Successful Treatment of Netherton Syndrome With Combination of Secukinumab and Dupilumab
In this study, we describe our experience with secukinumab (IL-17A inhibitor) and dupilumab (IL-4/IL-13 inhibitor) treatment of a group of pediatric patients with severe Neterton syndrome.
- Trial name
- NCT07151508
- Testing
- Secukinumab was administered in a weight-adapted dosing regimen ? Dupilumab was administered at a dose dependent on the patient's weight and age
- Where
- Russia
- Volunteers
- 15 people
- Sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Healthy Participants, Atopic Dermatitis Patients
A First In Human (FIH) Study of IBI356 in Healthy Participants and in Atopic Dermatitis Patients
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of IBI356 in Healthy Participants and in Atopic Dermatitis Patients
- Trial name
- NCT06193434
- Testing
- IBI356 for MAD, Dupilumab for MAD, IBI356 for SAD
- Where
- China
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Chronic Spontaneous Urticaria
Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)
Primary Objective: This study aimed to demonstrate the efficacy of dupilumab in study participants with CSU who remained symptomatic despite the use of H1 antihistamine (Study A and C: omalizumab naïve; Study B: omalizumab…
- Trial name
- NCT04180488
- Testing
- Dupilumab SAR231893, non sedating H1-antihistamine
- Where
- 98 sites in United States, Argentina and 9 more
- Volunteers
- 397 people
- Sponsor
- Sanofi
Atopic Dermatitis, Psoriasis
Molecular Signatures in Inflammatory Skin Disease
This pilot project intends to examine the utility of a systems medicine approach to identify regulatory networks and their perturbation in psoriasis and atopic dermatitis, and to obtain a comprehensive perspective on disease and…
- Trial name
- MSID (NCT03358693)
- Testing
- Anti-TNF, Anti-IL12/23, Anti-IL17
- Where
- Germany
- Volunteers
- 300 people
- Sponsor
- Prof. Dr. Stephan Weidinger
Atopic Dermatitis
A Long-term Data Collection Study of Participants in France Aged 6 Years Old or More With Atopic Dermatitis Receiving Dupilumab
This is a long-term study to collect data over 3 years in order to find out what is likely to happen in the future regarding participants 6 years of age and older who receive dupilumab for Atopic Dermatitis (AD) commonly known as…
- Trial name
- DUPILAB (NCT06169527)
- Testing
- Dupilumab
- Where
- 42 sites in France
- Volunteers
- 303 people
- Sponsor
- Sanofi
Keloid
Dupilumab in the Treatment of Keloids
This study is a prospective, randomized, double blind, placebo-controlled clinical trial. The study will include a total of 44 subjects with clinically measurable keloid lesions.
- Trial name
- NCT04988022
- Testing
- Dupilumab
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Bullous Pemphigoid
Compassionate Use of Dupilumab for Adult Patients With Bullous Pemphigoid
The objective of the program is to provide patients with Bullous Pemphigoid (BP), that participated in the R668-BP-1902 (NCT04206553) phase 2/3 study, dupilumab treatment and evaluate the long-term safety of dupilumab.
- Trial name
- NCT05906706
- Testing
- dupilumab
- Sponsor
- Regeneron Pharmaceuticals
Chronic Rhinosinusitis With Nasal Polyps, Asthma; Eosinophilic
A Real-world, Head-to-head Comparison of Dupilumab Versus Mepolizumab in Danish Patients With Chronic Rhinosinusitis With Nasal Polyps
The goal of this randomized clinical trial is to compare the effects of two newly available biological drugs for the treatment of severe chronic rhinosinusitis with nasal polyps in Danish patients.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps, Asthma; Eosinophilic, Eosinophilia
- Trial name
- TORNADO (NCT05942222)
- Testing
- dupilumab, mepolizumab
- Where
- 9 sites in Denmark
- Volunteers
- 220 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet