SHR-1819 / Jiangsu Hengrui Pharma - LARVOL DELTA

Safety, Pharmacokinetics, and Pharmacodynamics of SHR-1819 in Children and Adolescents with Uncontrolled Moderate-to-Severe Atopic Dermatitis:Results from a Multicenter, Open-label, Single-arm Phase Ib/II Study (EADV 2026) - No abstract available

Clinical • P1/2 data • PK/PD data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and Safety of SHR-1819 in Adult Patients with Prurigo Nodularis:Results from a Multicenter, Randomized, Double-blinded, Placebo-controlled Phase II/III Trial (The Results of the Phase II Trial) (EADV 2026) - No abstract available

Clinical • P2/3 data • Immunology • Prurigo Nodularis

Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=652 | Completed | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Active, not recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Aug 2026 | Trial primary completion date: Dec 2026 ➔ Aug 2026

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

Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=652 | Active, not recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Trial completion date: Mar 2026 ➔ Dec 2026 | Trial primary completion date: Mar 2026 ➔ Dec 2026

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

A Clinical Study on the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis (clinicaltrials.gov) - P2 | N=108 | Completed | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Recruiting ➔ Completed

Trial completion • Allergic Rhinitis • Immunology • Inflammation

A Study on the Bioavailability of SHR-1819 Injection Administered Subcutaneously Using Different Injection Devices in Healthy Subjects (clinicaltrials.gov) - P1 | N=160 | Completed | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE SUBCUTANEOUS INJECTIONS OF SHR-1819 IN PATIENTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS (clinicaltrials.gov) - P1 | N=21 | Completed | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis (clinicaltrials.gov) - P3 | N=196 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Allergic Rhinitis • Immunology • Inflammation

SHR-1819-204: A Phase Ib/II Study to Investigate the Safety of SHR-1819 in Children and Adolescents With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=51 | Completed | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis (clinicaltrials.gov) - P3 | N=196 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P3 trial • Allergic Rhinitis • Immunology • Inflammation

A Study of SHR-1819 in Patients With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=201 | Active, not recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Anti-IL-4Rα antibody SHR-1819 for moderate-to-severe atopic dermatitis: a randomized phase 2 study. (PubMed, BMC Med) - P2 | "SHR-1819 demonstrated promising efficacy in improving the signs and symptoms of AD, with a well-tolerated safety profile and favorable pharmacokinetic, and pharmacodynamic characteristics."

Journal • P2 data • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Pruritus

A Study on the Bioavailability of SHR-1819 Injection Administered Subcutaneously Using Different Injection Devices in Healthy Subjects (clinicaltrials.gov) - P1 | N=160 | Active, not recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Active, not recruiting | Initiation date: Dec 2025 ➔ Mar 2026

Enrollment closed • Trial initiation date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis (clinicaltrials.gov) - P2/3 | N=423 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | N=236 ➔ 423 | Trial completion date: Aug 2026 ➔ Oct 2028 | Trial primary completion date: Jun 2026 ➔ Oct 2028

Enrollment change • Trial completion date • Trial primary completion date • Immunology • Prurigo Nodularis

A Study of SHR-1819 Injection in Adolescents With Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=201 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2025 ➔ Mar 2026

Enrollment open • Trial initiation date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Extend Efficacy and Safety of SHR-1819 Injection in Adult Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=79 | Completed | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Enrolling by invitation ➔ Completed | N=240 ➔ 79

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

A Study of SHR-1819 in Patients With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study of SHR-1819 in Patients With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

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

A Phase III Study of SHR-1819 Injection in Adolescents With Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=201 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P3 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study of SHR-2173 in Participants With Systemic Lupus Erythematosus (clinicaltrials.gov) - P2 | N=245 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P2 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Study on the Bioavailability of SHR-1819 Injection Administered Subcutaneously Using Different Injection Devices in Healthy Subjects (clinicaltrials.gov) - P1 | N=160 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=652 | Active, not recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2025 ➔ Mar 2026

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

A Clinical Study on the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Allergic Rhinitis • Immunology • Inflammation

A Clinical Study on the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P2 trial • Allergic Rhinitis • Immunology • Inflammation

SHR-1819-204: A Phase Ib/II Study to Investigate the Safety of SHR-1819 in Children and Adolescents With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Trial completion date: Aug 2025 ➔ Dec 2025 | Trial primary completion date: Jun 2025 ➔ Sep 2025

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