felcorekibart (GSK5784283) / Jiangsu Hengrui Pharma, GSK - LARVOL DELTA

A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-1) (clinicaltrials.gov) - P3 | N=514 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

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

PERSISTCRSwNP2: A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) (clinicaltrials.gov) - P3 | N=218 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-1) (clinicaltrials.gov) - P3 | N=624 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

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

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

PERSISTCRSwNP1: A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) (clinicaltrials.gov) - P3 | N=218 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

PERSISTCRSwNP2: A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) (clinicaltrials.gov) - P3 | N=218 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-2) (clinicaltrials.gov) - P3 | N=370 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-1) (clinicaltrials.gov) - P3 | N=624 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-1) (clinicaltrials.gov) - P3 | N=514 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-2) (clinicaltrials.gov) - P3 | N=624 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283 (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

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

Efficacy and Safety of SHR-1905 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P2 | N=114 | Completed | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Active, not recruiting ➔ Completed

Trial completion • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283 (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P1 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=260 | Active, not recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Trial completion date: Apr 2025 ➔ Dec 2026 | Trial primary completion date: Apr 2025 ➔ Dec 2026

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

A Dose Finding Study With an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=307 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2027 ➔ Sep 2027

Enrollment closed • Trial completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Pharmacokinetics, Pharmacodynamics, Safety, and Preliminary Efficacy of Subcutaneous Injection of SHR-1905 in Adolescent Asthmatic Subjects - an Open-label, Single-dose Phase II Clinical Study (clinicaltrials.gov) - P2 | N=9 | Completed | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Active, not recruiting ➔ Completed

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

A Study to Investigate the Efficacy and Safety of SHR-1905 in Patients With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Investigate the Efficacy and Safety of SHR-1905 in Patients With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=70 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | N=20 ➔ 70 | Trial completion date: Sep 2026 ➔ Feb 2027 | Trial primary completion date: Apr 2026 ➔ Sep 2026

Enrollment change • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and Safety of SHR-1905 Injection in Subjects With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P3 | N=280 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

A Study to Investigate the Efficacy and Safety of SHR-1905 in Patients With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

AI-Guided Design and Development of HXN-1011: A Potent Anti-TSLP Biparatopic Antibody (EADV 2025) - "Furthermore, in an OVA-induced asthma model using hTSLP/hTSLPR transgenic mice, HXN- 1011 effectively reduced lung inflammation, as evidenced by decreased BALF cell counts, eosinophil levels, and CCL17 expression, outperforming both Tezepelumab and GSK5784283. Furthermore, in an MC903+OVA-induced skin and lung inflammation model, HXN-1011 demonstrated superior efficacy across all tested parameters including reductions in epidermal hyperplasia, immune cell infiltration and lung inflammation... HXN-1011 is a next-generation biparatopic antibody exhibiting exceptional potency and holding significant potential to enhance clinical efficacy in the treatment of TSLP-driven inflammatory diseases, including atopic dermatitis, asthma, chronic obstructive pulmonary disease (COPD), and other related indications. Preclinical studies and IND-enabling research for HXN-1011 are currently underway."

Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Dermatitis • Dermatology • Immunology • Inflammation • Pneumonia • Pulmonary Disease • Respiratory Diseases • CRLF2 • IL7R • STAT5 • STAT5AWqe • TSLP

Late Breaking Abstract - AI-guided biparatopic TSLP nanobody based TSLP/IL-4Rα and TSLP/ST2 bispecific antibodies for chronic respiratory diseases (ERS 2025) - " Epitope analysis validated an AI-guided biparatopic TSLP nanobody, exhibiting superior in vitro activity approximately 200-fold better than Tezepelumab, and also surpassing GSK5784283...It exhibited synergistic TARC inhibition in PBMCs and demonstrated superior anti-inflammatory effects in an OVA- induced asthma mouse model compared to Tezepelumab and Dupilumab...Similarly, the TSLP/ST2 BiAb matched the TSLP activity of the biparatopic nanobody and outperformed Astegolimab in ST2 activity of 10 times. The BiAbs derived from a best-in-class biparatopic TSLP nanobody hold significant promise for the treatment of asthma and COPD."

Late-breaking abstract • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases • CRLF2 • IL7R • TSLP

A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma (clinicaltrials.gov) - P3 | N=408 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

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

Hengrui initiates Phase III clinical trial of TSLP monoclonal antibody for asthma [Google translation] (163.com) - "On July 30, 2025 , the Drug Clinical Trial Registration and Information Disclosure Platform showed that Hengrui Medicine registered a Phase III clinical study to evaluate the efficacy and safety of SHR-1905 injection in patients with severe uncontrolled asthma. This is also the third indication approved for the drug."

Trial status • Asthma

A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma (clinicaltrials.gov) - P3 | N=408 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases