Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen 
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 11 Diseases   24 Trials   24 Trials   1081 News 


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  • ||||||||||  tezepelumab (AMG 157) / AstraZeneca, Amgen
    High TSLP Bronchoalveolar Lavage Levels Are Linked to Disease Severity in a Subset of Children with Severe Asthma (PENNSYLVANIA CONVENTION CENTER, Room 113 B-C (100 Level)) -  Mar 15, 2020 - Abstract #ATS2020ATS_3660;    
    High TSLP levels in this population was also associated with increased IL-5 levels, suggesting that TSLP may play a key role in mediating allergic TH2 bronchopulmonary responses in children as previously demonstrated in adults with asthma. These data indicate that TSLP may play a role in the pathogenesis of pediatric asthma and thus provide initial support to investigate the potential use of anti-TSLP biologics to treat severe asthma in children.
  • ||||||||||  Xolair (omalizumab) / Roche, Novartis
    Patient Clinical Characteristics and Biomarkers Associated with Underlying Exacerbation Risk in Asthma (PENNSYLVANIA CONVENTION CENTER, Room 113 B-C (100 Level)) -  Mar 15, 2020 - Abstract #ATS2020ATS_3651;    
    Evaluating pooled placebo patient populations will allow strategic insights into biomarker and patient clinical characteristics/response relationships for patients with asthma. Baseline blood eosinophil counts and FeNO are relevant predictors of exacerbation risk and uncontrolled asthma.
  • ||||||||||  tezepelumab (AMG 157) / AstraZeneca, Amgen
    Seasonal Variability of Exacerbations in Patients with Severe, Uncontrolled Asthma and Clinical Benefits of Tezepelumab: Results from the PATHWAY Phase 2b Study (PENNSYLVANIA CONVENTION CENTER, Hall G (100 Level)) -  Mar 15, 2020 - Abstract #ATS2020ATS_3320;    
    P2
    In the placebo group, the mean (standard deviation) numbers of days with exacerbations per patient were 2.5 (7.2), 1.6 (4.9), 1.9 (5.5) and 2.3 (7.4) during winter, spring, summer and fall, respectively, compared with 0.6 (2.8), 0.4 (2.0), 0.2 (1.6) and 0.7 (3.2), respectively, in the 210mg group, and 0.9 (3.7), 0.5 (2.8), 0.5 (3.0) and 0.8 (3.3), respectively, in the pooled tezepelumab group . Mean weekly exacerbation days per patient over the seasons are shown in Figure 1.ConclusionsIn patients with severe, uncontrolled asthma, treatment with tezepelumab reduced AAER, the proportion of patients with two or more exacerbations, and the mean number of days with exacerbations per patient versus placebo across all seasons.
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    Enrollment closed:  NOZOMI: Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma (clinicaltrials.gov) -  Mar 11, 2020   
    P3,  N=65, Active, not recruiting, 
    Tezepelumab treatment resulted in similar reductions in AAER in patients with high and low baseline levels of IL-5 and IL-13, providing further evidence that tezepelumab can meaningfully reduce exacerbations in a broad population of patients with severe asthma. Recruiting --> Active, not recruiting
  • ||||||||||  tezepelumab (AMG 157) / AstraZeneca, Amgen
    Development of a Highly Sensitive Assay to Quantitate Circulating Thymic Stromal Lymphopoietin (TSLP) Levels in Blood (Convention Center, 200 Level, Hall D) -  Mar 1, 2020 - Abstract #AAAAI2020AAAAI_1106;    
    Higher TSLP serum concentrations were detected in AD patients compared with healthy individuals and these concentrations were highly associated with AD severity. Our assay demonstrated TSLP quantitation with improved fg/mL-level sensitivity and may have utility in clinical studies evaluating aberrant TSLP levels.
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    Trial completion date, Trial primary completion date:  A Dose Ranging Placebo-Controlled Double-Blind Study to Evaluate the Safety and Efficacy of Tezepelumab in Atopic Dermatitis (clinicaltrials.gov) -  Feb 27, 2020   
    P2,  N=300, Recruiting, 
    Tezepelumab reduced exacerbations in patients with severe, uncontrolled asthma irrespective of baseline BMI, providing further evidence that tezepelumab can meaningfully reduce exacerbations in a broad population of patients with severe asthma. Trial completion date: Jul 2021 --> Oct 2021 | Trial primary completion date: Jul 2021 --> Oct 2021
  • ||||||||||  Retrospective data, Review, Journal:  Monoclonal antibodies in type 2 asthma: a systematic review and network meta-analysis. (Pubmed Central) -  Feb 7, 2020   
    Tralokinumab improved lung function compared to placebo...However, no statistically significant superiority was observed of one biologic over the other in the network meta-analysis. More studies with direct head to head comparisons and better defined endotypes are required.
  • ||||||||||  tezepelumab (AMG 157) / AstraZeneca, Amgen
    Journal:  Tezepelumab: a novel biological therapy for the treatment of severe uncontrolled asthma. (Pubmed Central) -  Nov 10, 2019   
    The results of preliminary clinical trials are encouraging. Several unanswered questions concerning basic pathophysiological aspects of TSLP variants, the long-term safety and efficacy of tezepelumab with different phenotypes/endotypes of asthma should be addressed.
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    Trial completion date, Trial primary completion date:  DIRECTION: Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma (clinicaltrials.gov) -  Nov 1, 2019   
    P3,  N=396, Recruiting, 
    Several unanswered questions concerning basic pathophysiological aspects of TSLP variants, the long-term safety and efficacy of tezepelumab with different phenotypes/endotypes of asthma should be addressed. Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Jun 2023 --> Dec 2023
  • ||||||||||  Xolair (omalizumab) / Roche, Novartis
    Biomarker, Journal:  Novel Biological Therapies in Severe Asthma: Targeting the Right Trait. (Pubmed Central) -  Oct 30, 2019   
    Unfortunately, little is known about non-type 2 asthma. Further studies are needed to identify biomarkers to guide targeted therapies of different forms of non-type 2 asthma.
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    Enrollment closed:  PATH-HOME: Tezepelumab Home Use Study (clinicaltrials.gov) -  Oct 6, 2019   
    P3,  N=216, Active, not recruiting, 
    Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    Enrollment open:  COURSE: Tezepelumab COPD Exacerbation Study (clinicaltrials.gov) -  Aug 20, 2019   
    P2a,  N=282, Recruiting, 
    Co-sponsored by MedImmune, a member of the AstraZeneca Group, and Amgen Inc. Not yet recruiting --> Recruiting
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    New P2a trial:  COURSE: Tezepelumab COPD Exacerbation Study (clinicaltrials.gov) -  Jul 30, 2019   
    P2a,  N=282, Not yet recruiting, 
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    Enrollment open, Trial completion date, Trial primary completion date:  DIRECTION: Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma (clinicaltrials.gov) -  Jun 25, 2019   
    P3,  N=396, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Trial completion date: Dec 2022 --> Apr 2023 | Trial primary completion date: Dec 2022 --> Apr 2023
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    New P3 trial:  PATH-HOME: Tezepelumab Home Use Study (clinicaltrials.gov) -  May 29, 2019   
    P3,  N=210, Recruiting, 
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    Trial primary completion date:  Effects of Anti-TSLP in Patients With Asthma (clinicaltrials.gov) -  Apr 28, 2019   
    P2,  N=40, Recruiting, 
    Not yet recruiting --> Recruiting | Trial completion date: Dec 2022 --> Apr 2023 | Trial primary completion date: Dec 2022 --> Apr 2023 Trial primary completion date: Dec 2018 --> Sep 2019
  • ||||||||||  Xolair (omalizumab) / Roche, Novartis
    Clinical, Review, Journal:  New perspectives of childhood asthma treatment with biologics. (Pubmed Central) -  Apr 14, 2019   
    ...Omalizumab and, more recently, mepolizumab are the first biologics approved for children (6-18 years)...Moreover, several other drugs-lebrikizumab, dupilumab, tezepelumab, mepolizumab, reslizumab, benralizumab-are used or are being studied in both teenagers and adults and could benefit younger children in the near future...Long-term effectiveness and particularly the impact on the natural history of asthma should also be investigated. Severe asthma in children is a complex disease and patients have to be referred to a specialized pediatric asthma center to confirm diagnosis and initiate the best treatment strategy which could include biologics whilst taking into account their high cost.