Heribert Staudinger
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View article: A Randomized Phase I Trial Evaluating Safety and Pharmacokinetics of Single and Multiple Ascending Doses of Eclitasertib, a RIPK1 Inhibitor, in Healthy Participants
A Randomized Phase I Trial Evaluating Safety and Pharmacokinetics of Single and Multiple Ascending Doses of Eclitasertib, a RIPK1 Inhibitor, in Healthy Participants Open
EudraCT 2019-001350-25.
View article: Long-Term Efficacy of Dupilumab in Moderate-to-Severe Asthma Phenotyped by Blood Eosinophils and Exhaled Nitric Oxide
Long-Term Efficacy of Dupilumab in Moderate-to-Severe Asthma Phenotyped by Blood Eosinophils and Exhaled Nitric Oxide Open
Background: Asthma treatment aims to reduce symptom severity and exacerbation risk. Dupilumab, a human monoclonal antibody, blocks the shared receptor for IL-4/IL-13, key drivers of type 2 inflammation. In the Evaluation of Dupilumab in Pa…
View article: A first‐in‐human, single and multiple dose study of lunsekimig, a novel anti‐<scp>TSLP</scp>/anti‐<scp>IL</scp>‐13 <scp>NANOBODY</scp>® compound, in healthy volunteers
A first‐in‐human, single and multiple dose study of lunsekimig, a novel anti‐<span>TSLP</span>/anti‐<span>IL</span>‐13 <span>NANOBODY</span>® compound, in healthy volunteers Open
Lunsekimig is a novel, bispecific NANOBODY® molecule that inhibits both thymic stromal lymphopoietin (TSLP) and interleukin (IL)‐13, two key mediators of asthma pathophysiology. In this first‐in‐human study, we evaluated the safety, tolera…
View article: AERIFY-1/2: two phase 3, randomised, controlled trials of itepekimab in former smokers with moderate-to-severe COPD
AERIFY-1/2: two phase 3, randomised, controlled trials of itepekimab in former smokers with moderate-to-severe COPD Open
Background Accumulating data implicate interleukin (IL)-33, a proinflammatory cytokine released locally upon epithelial cell damage, in the pathogenesis of COPD. In a phase 2 study, itepekimab, a human monoclonal antibody against IL-33, re…
View article: Dupilumab in patients with chronic spontaneous urticaria (LIBERTY-CSU CUPID): Two randomized, double-blind, placebo-controlled, phase 3 trials
Dupilumab in patients with chronic spontaneous urticaria (LIBERTY-CSU CUPID): Two randomized, double-blind, placebo-controlled, phase 3 trials Open
Dupilumab reduced urticaria activity by reducing itch and hives severity in omalizumab-naive patients with CSU uncontrolled with H1-AH. Although the primary end point for Study B was not met, dupilumab effects were small in patients who we…
View article: Immunomodulatory and clinical effects of receptor-interacting protein kinase 1 (RIPK1) inhibitor eclitasertib (SAR443122) in patients with severe COVID-19: a phase 1b, randomized, double-blinded, placebo-controlled study
Immunomodulatory and clinical effects of receptor-interacting protein kinase 1 (RIPK1) inhibitor eclitasertib (SAR443122) in patients with severe COVID-19: a phase 1b, randomized, double-blinded, placebo-controlled study Open
Background Targeting receptor-interacting serine/threonine protein kinase 1 could mitigate the devastating sequelae of the hyperinflammatory state observed in severe cases of COVID-19. This study explored the immunomodulatory and clinical …
View article: Blood eosinophils and fractional exhaled nitric oxide are prognostic and predictive biomarkers in childhood asthma
Blood eosinophils and fractional exhaled nitric oxide are prognostic and predictive biomarkers in childhood asthma Open
Liberty Asthma VOYAGE ClinicalTrials.gov NCT02948959.
View article: Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts
Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts Open
Among patients with COPD who had type 2 inflammation as indicated by elevated blood eosinophil counts, those who received dupilumab had fewer exacerbations, better lung function and quality of life, and less severe respiratory symptoms tha…
View article: Dupilumab in patients with prurigo nodularis: two randomized, double-blind, placebo-controlled phase 3 trials
Dupilumab in patients with prurigo nodularis: two randomized, double-blind, placebo-controlled phase 3 trials Open
Prurigo nodularis (PN) is a chronic inflammatory skin disease with intensely pruritic nodules. The LIBERTY-PN PRIME and PRIME2 phase 3 trials enrolled adults with PN with ≥20 nodules and severe itch uncontrolled with topical therapies. Dup…
View article: Development of Core Outcome Measures sets for paediatric and adult Severe Asthma (COMSA)
Development of Core Outcome Measures sets for paediatric and adult Severe Asthma (COMSA) Open
Background Effectiveness studies with biological therapies for asthma lack standardised outcome measures. The COMSA (Core Outcome Measures sets for paediatric and adult Severe Asthma) Working Group sought to develop Core Outcome Measures (…
View article: 3TR: a pan-European cross-disease research consortium aimed at improving personalised biological treatment of asthma and COPD
3TR: a pan-European cross-disease research consortium aimed at improving personalised biological treatment of asthma and COPD Open
3TR, the largest IMI consortium ever in immune diseases, brings clinical researchers and scientists from several disease areas together, in an endeavour to increase the clinical impact of targeted immune-mediated therapies, including asthm…
View article: Dose counter performance of mometasone furoate/formoterol inhalers in subjects with asthma or COPD
Dose counter performance of mometasone furoate/formoterol inhalers in subjects with asthma or COPD Open
BACKGROUND: Consistent delivery of medication to treat asthma and chronic obstructive pulmonary disease (COPD) is critical for disease control. Dose tracking may eliminate the possibility of sub-therapeutic dosing. This study evaluated the…
View article: <p>Dupilumab Efficacy in Patients Stratified by Baseline Treatment Intensity and Lung Function</p>
Dupilumab Efficacy in Patients Stratified by Baseline Treatment Intensity and Lung Function Open
Dupilumab reduced severe exacerbations and improved lung function, asthma control and quality of life in patients with elevated baseline eosinophils irrespective of baseline ICS dose or FEV1% predicted.
View article: Efficacy and Safety of Multiple Dupilumab Dose Regimens After Initial Successful Treatment in Patients With Atopic Dermatitis
Efficacy and Safety of Multiple Dupilumab Dose Regimens After Initial Successful Treatment in Patients With Atopic Dermatitis Open
ClinicalTrials.gov identifier: NCT02395133.
View article: The effect of dupilumab on lung function parameters in patients with oral corticosteroid-dependent severe asthma
The effect of dupilumab on lung function parameters in patients with oral corticosteroid-dependent severe asthma Open
Background: In Phase 3 LIBERTY ASTHMA VENTURE (NCT02528214), add-on dupilumab reduced oral corticosteroid (OCS) use while reducing severe exacerbations and improving pre-bronchodilator (BD) forced expiratory volume in 1 s (FEV1) in OCS-dep…
View article: Efficacy and Safety of Dupilumab in Adolescents With Uncontrolled Moderate to Severe Atopic Dermatitis
Efficacy and Safety of Dupilumab in Adolescents With Uncontrolled Moderate to Severe Atopic Dermatitis Open
ClinicalTrials.gov identifier: NCT03054428.
View article: Validation of the Peak Pruritus Numerical Rating Scale
Validation of the Peak Pruritus Numerical Rating Scale Open
Atopic dermatitis (AD) is a chronic skin disease occurring in about 5 to 10% of adults worldwide. It can cause intense and persistent itch. For almost two-thirds of patients with moderate-to-severe AD, the itching lasts at least 12 hours a…
View article: Conjunctivitis in dupilumab clinical trials
Conjunctivitis in dupilumab clinical trials Open
BACKGROUND: Dupilumab, which blocks the shared receptor component for interleukin (IL)-4 and IL-13, is approved for inadequately-controlled moderate-to-severe atopic dermatitis (AD) and moderate-to-severe eosinophilic or oral corticosteroi…
View article: Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study
Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study Open
The safety and efficacy profile from this study supports the role of dupilumab as continuous long-term treatment for patients with moderate to severe AD.
View article: Dupilumab improves patient-reported outcomes in patients with chronic rhinosinusitis with nasal polyps and comorbid asthma
Dupilumab improves patient-reported outcomes in patients with chronic rhinosinusitis with nasal polyps and comorbid asthma Open
sponsorship: The research was sponsored by Sanofi and Regeneron Pharmaceuticals. (Sanofi, Regeneron Pharmaceuticals)
View article: Conjunctivitis in dupilumab clinical trials
Conjunctivitis in dupilumab clinical trials Open
Conjunctivitis was more frequent with dupilumab treatment in most AD trials. In dupilumab trials in other type 2 diseases, incidence of conjunctivitis was overall very low, and was similar for dupilumab and placebo. In AD, the incidence of…
View article: Peak Pruritus Numerical Rating Scale: psychometric validation and responder definition for assessing itch in moderate‐to‐severe atopic dermatitis
Peak Pruritus Numerical Rating Scale: psychometric validation and responder definition for assessing itch in moderate‐to‐severe atopic dermatitis Open
The Peak Pruritus NRS is a well-defined, reliable, sensitive and valid scale for evaluating worst itch intensity in adults with moderate-to-severe AD.