Clinical trials: Dupilumab
Healthy
Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects
Primary Objective: To determine and compare the pharmacokinetic (PK) profiles of 2 different SAR231893 (REGN668) drug products after administration of a single subcutaneous (SC) dose Secondary Objective: To determine and compare…
- Trial name
- NCT01537640
- Testing
- SAR231893 (REGN668) DP1, SAR231893 (REGN668) DP2
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Sanofi
Atopic Dermatitis, AD
An Open-label, Single-arm Longitudinal Study With Dupilumab for Patients With Atopic Dermatitis
24-week, open-label, single-arm longitudinal study of patients with AD, including a comparison between baseline values for adult patients with moderate-to-severe AD and untreated normal control patients.
- Conditions
- Atopic Dermatitis, AD, Eczema
- Trial name
- NCT04520308
- Testing
- Dupilumab Only Product
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Eric Simpson
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.
Healthy
Ascending Dose Study of the Safety and Tolerability of REGN668(SAR231893) in Normal Healthy Volunteers
This study will test the safety and tolerability (how the body reacts to the drug) of REGN668 and placebo (an inactive substance that contains no medicine) in healthy subjects.
- Trial name
- NCT01015027
- Testing
- REGN668
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
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.
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.
Chronic Rhinosinusitis (Diagnosis), COVID-19
The Nasal Microbiome and Its Importance in Disease
Methods: all studies are case control studies on six different groups: normal individuals, non-COVID-19 patients with olfactory dysfunction, COVID-19 positive patients, previous COVID-19 positive patients with prolonged olfactory…
- Conditions
- Chronic Rhinosinusitis (Diagnosis), COVID-19, Anosmia
- Trial name
- NCT05061329
- Where
- Denmark
- Volunteers
- 619 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
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
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
Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis
This is a multi-center, longitudinal study which will characterize the gene expression profiles and transcriptomic endotypes that underlie mild and moderate-severe Atopic dermatitis (AD) and will determine changes in these…
- Trial name
- LEADS (NCT05436535)
- Testing
- Dupilumab, Vanicream- Dupilumab-naïve, Triamcinolone Acetonide
- Where
- 10 sites in United States
- Volunteers
- 433 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Major Depressive Disorder
Dupilumab in Major Depressive Disorder
This study aims primarily to test target engagement of dupilumab by assessing changes in peripheral immune markers following interleukin-4 receptor alpha (IL-4Rα) blockade in adults with major depressive disorder (MDD).
- Trial name
- NCT07908563
- Testing
- Dupilumab Injection
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
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.
Aspirin-exacerbated Respiratory Disease
Dupilumab for Aspirin-exacerbated Respiratory Disease
Subjects with physician-diagnosed aspirin-exacerbated respiratory disease (AERD) who remain unacceptably symptomatic with a SNOT 22 score > 18 despite routine medical therapy will be enrolled in this single center, single-blinded…
- Trial name
- NCT03595488
- Testing
- Dupilumab
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Rochester General Hospital
Olfactory Dysfunction, Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Neural Dissimilarity in Patients With Chronic Rhinosinusitis With Nasal Polyps Treated With Biologics
This project will focus on rehabilitation of olfactory dysfunction in patients with chronic rhinosinusitis with polyps given biological treatment based on functional magnetic resonance imaging.
- Conditions
- Olfactory Dysfunction, Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), Functional Magnetic Resonance Imaging (fMRI)
- Trial name
- NCT07819162
- Where
- Denmark
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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
Healthy Volunteers
Pharmacokinetics and Tolerability of Subcutaneous Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants
This is a Phase 1 study with 2 parallel groups of healthy participants. Participants will be randomized to receive either a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa or a SC dose of dupilumab…
- Trial name
- NCT07646548
- Testing
- Dupilumab coformulated with berahyaluronidase alfa, Dupilumab
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sanofi
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.
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