SHR-1703 / Jiangsu Hengrui Pharma - LARVOL DELTA

A randomized, double-blind, placebo-controlled clinical study evaluating the efficacy and safety of subcutaneous injection of SHR-1703 in patients with allergic bronchopulmonary aspergillosis (ABPA) (ChiCTR) - P=N/A | N=21 | Not yet recruiting | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University

New trial • Allergic Bronchopulmonary Aspergillosis • Pulmonary Disease • Respiratory Diseases

A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

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

A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

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

Safety, pharmacokinetics and pharmacodynamics of SHR-1703, an anti-interleukin-5 monoclonal antibody, in healthy subjects: a phase I randomized, placebo-controlled trial (ERS 2024) - "SHR-1703 may be a potential therapeutic approach of eosinophilia-associated diseases owing to good safety profiles and obvious efficacy in reducing the level of eosinophils in healthy Chinese subjects."

Clinical • P1 data • PK/PD data • Eosinophilia • Inflammation • IL5

A Study to Evaluate the Long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

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

Safety, pharmacokinetics and pharmacodynamics of SHR-1703, an innovative long-acting anti-interleukin-5 monoclonal antibody, in healthy subjects: a randomized, double-blind, dose-escalation, placebo-controlled phase I study. (PubMed, Expert Opin Investig Drugs) - P1 | "Pharmacokinetics, pharmacodynamics, immunogenicity, safety and tolerability of SHR-1703 support further clinical development of SHR-1703 in eosinophil-associated diseases. The study was registered on the ClinicalTrials.gov (identifier: NCT04480762)."

Clinical • Journal • P1 data • PK/PD data • IL5

A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA） (clinicaltrials.gov) - P2/3 | N=112 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2023 ➔ Nov 2023

Enrollment open • Trial initiation date • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Langerhans Cell Histiocytosis • Rare Diseases • Vasculitis

A Study to Evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients With Eosinophil Phenotype (clinicaltrials.gov) - P2 | N=85 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

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

A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA） (clinicaltrials.gov) - P2/3 | N=112 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P2/3 trial • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Langerhans Cell Histiocytosis • Rare Diseases • Vasculitis

A Trial of SHR-1703 in Asthma (clinicaltrials.gov) - P1 | N=23 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

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

A Study to Evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients With Eosinophil Phenotype (clinicaltrials.gov) - P2 | N=84 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A Trial of SHR-1703 in Healthy Adults (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

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

A Study to Evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients With Eosinophil Phenotype (clinicaltrials.gov) - P2 | N=84 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

A Trial of SHR-1703 in Asthma (clinicaltrials.gov) - P1 | N=22 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting | N=16 ➔ 22 | Trial completion date: Sep 2022 ➔ Jun 2023 | Trial primary completion date: Sep 2022 ➔ Jun 2023

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

A Trial of SHR-1703 in Healthy Subjects (clinicaltrials.gov) - P1; N=1; Terminated; Sponsor: Atridia Pty Ltd.; N=48 ➔ 1; Trial completion date: Dec 2022 ➔ Nov 2021; Recruiting ➔ Terminated; Trial primary completion date: Jun 2022 ➔ Sep 2021; Adjustment of the clinical development plan for this product globally

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

A Trial of SHR-1703 in Healthy Adults (clinicaltrials.gov) - P1; N=42; Active, not recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Not yet recruiting ➔ Active, not recruiting; Trial completion date: Feb 2021 ➔ Dec 2021; Trial primary completion date: Feb 2021 ➔ Sep 2021

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

A Trial of SHR-1703 in Asthma (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

A Trial of SHR-1703 in Healthy Subjects (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: Atridia Pty Ltd.; Not yet recruiting ➔ Recruiting

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

A Trial of SHR-1703 in Healthy Subjects (clinicaltrials.gov) - P1; N=48; Not yet recruiting; Sponsor: Atridia Pty Ltd.

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

A Trial of SHR-1703 in Healthy Adults (clinicaltrials.gov) - P1; N=42; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Clinical • New P1 trial • Asthma • Respiratory Diseases