Clinical trials: Dupilumab
Eosinophilic Esophagitis (EoE)
Local Clinical and Immunological Responses in Eosinophilic Esophagitis (EoE) Patients, Role of Mucosal Barrier Function and Type II Inflammation
Eosinophilic esophagitis (EoE) is an allergic inflammation of the esophagus. If not treated properly, inflammation and narrowing of the esophagus can occur. This can eventually lead to food impaction.
- Trial name
- SINFONIA (NCT07012928)
- Where
- Netherlands
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.
Skin Inflammation, Allergic Contact Dermatitis
Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
The purpose of this study is to answer: how do inflammation and anti-inflammatory skin therapies work in the skin? Inflammation is a protective response from the body's immune system to injury, disease, or irritation.
- Trial name
- NCT05535738
- Testing
- Squaric Acid Dibutyl Ester, Known patch test allergens, Dupilumab
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Wei-Che Ko
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
Healthy Volunteers
A Study to Investigate the Pharmacokinetics (PK), Tolerability and Safety of Two Different Dupilumab Drug Products in Healthy Participants.
This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetic of 2 different dupilumab drug products in adult healthy volunteers. The duration per participant is up to 11 weeks.
- Trial name
- NCT05976373
- Testing
- Dupilumab (SAR231893)
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy Participants
A Phase I Study of 9MW4113 Injection Versus Dupixent®
It is a randomized, double-blinded, parallel, single-dose, Phase I comparative study to evaluate the pharmacokinetic, safety, and immunogenicity similarity between 9MW4113 and Dupixent® in healthy Chinese adult participants.
- Trial name
- NCT07791342
- Testing
- 9MW4113 injection, Dupilumab
- Where
- China
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Atopic Dermatitis
A PhaseⅠ Comparative Study to Evaluate the Pharmacokinetics of QL2108 to Dupixent®
It is a randomized, double-blinded, parallel, single-dose, PhaseⅠcomparative study to evaluate the pharmacokinetics and safety of QL2108 to Dupixent® in healthy Chinese adult subjects.
- Trial name
- NCT06614907
- Testing
- QL2108 injection, Dupixent®
- Where
- China
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Eosinophilic Esophagitis
A Non-interventional Observational Study to Assess Long-term Efficacy and Safety of Dupilumab for the Treatment of Patients (>= 12 Years) With Eosinophilic Esophagitis Under Real-world-conditions in Germany
This is a longitudinal, observational non-interventional study (NIS) designed to characterize the patient population who receives dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany with…
- Trial name
- ProMEAL (NCT06695897)
- Testing
- Dupilumab
- Where
- 15 sites in Germany
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Sanofi
Chronic Spontaneous Urticaria (CSU), Hidradenitis Suppurativa (HS)
SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
The goal of this observational study is to comprehensively profile six immune-mediated inflammatory diseases, including atopic dermatitis (AD), plaque psoriasis (PSO), hidradenitis suppurativa (HS), cutaneous T-cell lymphoma…
- Conditions
- Chronic Spontaneous Urticaria (CSU), Hidradenitis Suppurativa (HS), Psoriasis (PsO), Atopic Dermatitis (AD)
- Trial name
- SKINERGY (NCT07021495)
- Where
- 8 sites in Netherlands
- Volunteers
- 840 people, healthy volunteers welcome
- Sponsor
- Leiden University Medical Center
Atopic Dermatitis
IL-4 and Insulin Resistance for Treatment of Patients With Atopic Dermatitis
The purpose of this study is to better understand the interactions between the innate immune system, in particular eosinophils, their secreted cytokines (interleukin-4), and metabolism in human health and disease states such as…
- Trial name
- NCT05372003
- Testing
- Dupilumab, Photo therapy
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Atopic Dermatitis (AD), Asthma
Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy
The objective is to evaluate the potential effect of exposure to dupilumab in pregnancy compared to the primary comparison group of disease-matched pregnant women who are not exposed to dupilumab, and the secondary comparison…
- Trial name
- NCT04173442
- Testing
- dupilumab
- Where
- United States
- Volunteers
- 581 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
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
Nasal Polyps, Sinusitis
Dupixent Study for Alternate Administration
Investigators will investigate an alternate Dupilumab administration schedule in patients with recurrent chronic rhinosinusitis with nasal polyposis, who have a history of full endoscopic sinus surgery and are on appropriate…
- Conditions
- Nasal Polyps, Sinusitis, Chronic Disease
- Trial name
- NCT06750471
- Testing
- Dupilumab
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Madigan Army Medical Center
Biosimilarity
A Study to Evaluate the Biosimilarity of GLR1044 Injection and Dupilumab Injection (Dupixent®) in Healthy Adult Male Subjects
This is a randomized, double-blind, single-dose, parallel comparison biosimilarity study conducted in healthy Chinese adult male subjects. It is planned to enroll 198 male subjects in this study.
- Trial name
- NCT07334496
- Testing
- GLR1044 injection, Dupilumab Injection
- Where
- China
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- Gan & Lee Pharmaceuticals.
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
Chronic Rhinosinusitis (Diagnosis)
Viral and Epigenetic Influences in CRSwNP
Background/rationale While multiple disorders feature a Type 2 (T2) inflammation, triggers for T2 remains unknown. In Chronic Rhinosinusitis with Nasal Polyposis CRSwNP), a classic Type 2 disorder, dysfunction of the epithelial…
- Trial name
- NCT05857228
- Testing
- Endoscopic sinus surgery (ESS)
- Where
- Canada
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
Asthma Atopic, Asthma Severe Persistent Uncontrolled
Expression of TSLP Isoforms in Asthma
Asthma is a heterogeneous disease characterized by chronic airway inflammation, leading to variable airflow obstruction, bronchial hyperresponsiveness, excessive mucus secretion, and, consequently, structural airway remodeling.
- Trial name
- NCT07786870
- Testing
- No Intervention: Observational Cohort
- Where
- Poland
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Medical University of Warsaw
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
AERD - Aspirin Exacerbated Respiratory Disease
Effect of Dupilumab on Aspirin Intolerance
To test the efficacy of dupilumab in patients with AERD regarding the intolerance to salicylic acid after 6 months. This will be evaluated by oral drug provocation testing with low dose salicylic acid after 6 months of dupilumab…
- Trial name
- NCT04442256
- Testing
- Dupilumab
- Where
- Austria
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Healthy Volunteer
A Study to Investigate the Pharmacokinetics, Tolerability and Safety of Two Different Dupilumab Drug Products in Healthy Participants
This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetics of 2 different dupilumab drug product in healthy volunteers. The duration per participant is up to 11 weeks.
- Trial name
- NCT05976360
- Testing
- Dupilumab (SAR231893)
- Where
- 2 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Sanofi