ecleralimab (CSJ117) / Novartis - LARVOL DELTA

Lessons learned from clinical trials of thymic stromal lymphopoietin (TSLP) inhibition. (PubMed, J Allergy Clin Immunol) - "Tezepelumab is currently the only approved anti-TSLP therapy. Other TSLP-targeting agents, including ecleralimab, SHR-1905, bosakitug, verekitug, sunakiment, TAVO101, ocankitug, HBM9378, MG-ZG122, GB-0895, and solrikitug, are in clinical development."

Journal • Review • Allergic Rhinitis • Allergy • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Dermatitis • Dermatology • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis • Urticaria • IL13 • IL5 • TSLP

Inhaled anti-thymic stromal lymphopoietin antibody fragment, ecleralimab, in severe asthma: A placebo-controlled, multicenter, double-blind, randomized, phase 2b clinical trial. (PubMed, Am J Respir Crit Care Med) - No abstract available

Journal • P2b data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • TSLP

Advancements in Biologic Therapies for Pediatric Asthma: Emerging Therapies and Future Directions. (PubMed, Cureus) - "Biologics such as omalizumab, mepolizumab, dupilumab, benralizumab, and tezepelumab have been reported to reduce severe asthma exacerbations, with reassuring short-term safety profiles among children and adolescents (pediatrics)...Literature review also highlights the emerging treatment regimens for non-T2 endotypes, such as tezepelumab, ecleralimab, and astegolimab (IL-33), which influence both T2 and non-T2 pathways...Ultimately, the continued advancement and strategic implementation of biologic therapies hold the potential to revolutionize the management of severe pediatric asthma, leading to reduced exacerbations and corticosteroid use, improved quality of life, and more precise treatment strategies tailored to individual patient profiles. Moreover, future research should continue to address the challenges related to long-term safety, cost-effectiveness, and equitable access, which are vital to realizing the true potential of biologic therapies in treating pediatric..."

Journal • Review • Asthma • Immunology • Inflammation • Pediatrics • Pulmonary Disease • Respiratory Diseases • IL33

Investigational thymic stromal lymphopoietin inhibitors for the treatment of asthma: a systematic review. (PubMed, Expert Opin Investig Drugs) - "Currently, the only TSLP inhibitor approved for the treatment of severe asthma is the immunoglobulin G (IgG) 2λ anti-TSLP monoclonal antibody (mAb) tezepelumab...Ecleralimab, an inhaled antibody fragment antigen binding, shows promising evidence in enhancing efficacy and reducing systemic adverse events. SAR443765, with its NANOBODY® formulation and bispecific inhibition of TSLP and IL-13, offers improved tissue penetration and efficacy. The mAB TQC2731 exhibits high in vitro bioactivity, and the strength of the mAb UPB-101 is to act against the TSLP receptor...This systematic review highlights the potential of TSLP inhibitors as valuable additions to asthma treatment, even in milder forms of the disease. Future research and cost-reduction efforts are needed to expanding access to these promising therapies."

Journal • Review • Stroma • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CRLF2 • IL13 • TSLP

Inhaled anti-TSLP antibody fragment, ecleralimab, blocks responses to allergen in mild asthma. (PubMed, Eur Respir J) - "Ecleralimab significantly attenuated allergen-induced bronchoconstriction and airway inflammation and was safe in subjects with mild atopic asthma."

Journal • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • TSLP

Development of an inhaled anti-TSLP therapy for asthma. (PubMed, Pulm Pharmacol Ther) - "TSLP plays a role in asthma pathogenesis as an upstream cytokine, and data suggest that TSLP blockade with the anti-TSLP monoclonal antibody, tezepelumab, could be efficacious in a broad asthma population. A Phase IIa proof of concept study, using allergen bronchoprovocation as a model for asthma exacerbations, found that ecleralimab was well-tolerated and reduced allergen-induced bronchoconstriction in adult patients with mild asthma. These results suggest ecleralimab may be a promising, new therapeutic class for asthma treatment."

Journal • Review • Asthma • Eosinophilia • Hematological Disorders • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CRLF2

"The article is from 2020. The committee hearings to strengthen the #CanadaDisabilityBenefit #cdb #pwd are happening now with two remaining dates for letters and presentations on Nov14&16 Huma committee on Parlvu website C-22, link through Google." (,@Gail_Nestel)

Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD (clinicaltrials.gov) - P2 | N=38 | Completed | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Completed | N=300 ➔ 38 | Trial completion date: Aug 2023 ➔ Sep 2022 | Trial primary completion date: Aug 2023 ➔ Sep 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=136 | Terminated | Sponsor: Novartis Pharmaceuticals | N=325 ➔ 136 | Recruiting ➔ Terminated; Sponsor Decision

Enrollment change • Trial termination • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=336 | Terminated | Sponsor: Novartis Pharmaceuticals | N=625 ➔ 336 | Trial completion date: Feb 2024 ➔ Sep 2022 | Recruiting ➔ Terminated | Trial primary completion date: Nov 2023 ➔ Jul 2022; Sponsor Desicion

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

"$NVS's CSJ117 has the same MoA as $AMGN & $AZN's Tezspire, approved for severe asthma in Dec 2021 - analysts had hoped for a mod-to-severe label & expectations have come down" (,@ByMadeleineA)

Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

"$NVS CSJ117, Keymed's CM326 & Biosion's BSI045B are apparently the only anti-TSLP MAbs challenging $AMGN $AZN tezepelumab https://t.co/JEDcieq56y" (,@JacobPlieth)

"$NVS is also seeking to partner out CPK850 (RLBP 1 gene therapy for retinitis pigmentosa) & CSJ117 (anti-TSLP MAb for asthma)" (,@JacobPlieth)

Asthma • Gene Therapies • Genetic Disorders • Immunology • Inherited Retinal Dystrophy • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases • Retinal Disorders • Retinitis Pigmentosa

Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=325 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Aug 2024 ➔ Sep 2022 | Trial primary completion date: May 2024 ➔ Jul 2022

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=325 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jun 2023 ➔ Aug 2024 | Trial primary completion date: Mar 2023 ➔ May 2024

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=625 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Dec 2022 ➔ Feb 2024 | Trial primary completion date: Sep 2022 ➔ Nov 2023

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma (clinicaltrials.gov) - P2; N=325; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Oct 2022 ➔ Jun 2023; Trial primary completion date: Jul 2022 ➔ Mar 2023

Clinical • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma (clinicaltrials.gov) - P2; N=625; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Apr 2022 ➔ Dec 2022; Trial primary completion date: Dec 2021 ➔ Sep 2022

Clinical • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study of effect of CSJ117 on symptoms, pharmacodynamics and safety in patients with COPD (clinicaltrialsregister.eu) - P2; N=300; Ongoing; Sponsor: Novartis Pharma AG

Clinical • New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Study of safety of CSJ117 in participants with moderate to severe uncontrolled asthma (clinicaltrialsregister.eu) - P2; N=375; Ongoing; Sponsor: Novartis Pharma AG

Clinical • New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD (clinicaltrials.gov) - P2; N=300; Recruiting; Sponsor: Novartis Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma (clinicaltrials.gov) - P2; N=325; Recruiting; Sponsor: Novartis Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD (clinicaltrials.gov) - P2; N=300; Not yet recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: May 2023 ➔ Aug 2023; Trial primary completion date: May 2023 ➔ Aug 2023

Clinical • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma (clinicaltrials.gov) - P2; N=325; Not yet recruiting; Sponsor: Novartis Pharmaceuticals

Clinical • New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

[VIRTUAL] The Sputum Transcriptome of Mild Atopic Asthma Following Bronchoprovocation and Inhaled Anti-TSLP Antibody Fragment Treatment (ATS 2021) - "Our optimized sputum processing and RNA extraction protocols resulted in high quality transcriptome data allowing for molecular assessment of the allergen-induced changes in sputum confirming the utility of bronchoprovocation model in mild asthma. The results further our understanding of CSJ117 effect on Th2 pathway in mild atopic asthma patients. These data substantiates the anticipated mode of action of CSJ117 at the molecular level."

Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL13 • IL4 • IL5 • TSLP