SHR-1139 / Jiangsu Hengrui Pharma - LARVOL DELTA

Efficacy and safety of SHR-1139, a novel anti-IL-23p19/IL-36R bispecific antibody, in patients with moderate-to-severe plaque psoriasis: interim results from a randomized, double-blind, placebo-controlled phase 2 trial (EADV 2026) - No abstract available

Bispecific • Clinical • P2 data • Dermatology • Immunology • Plaque Psoriasis • Psoriasis

A Clinical Study Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Ulcerative Pyoderma Gangrenosum (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Shandong First Medical University | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Pyoderma Gangrenosum

Phase II Clinical Trial of SHR-1139 Injection in Patients With Psoriasis (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

A Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1139 Injection in Patients With Plaque Psoriasis (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P2 trial • Dermatology • Immunology • Psoriasis

Phase II Clinical Trial of SHR-1139 Injection in Patients With Psoriasis (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P2 trial • Dermatology • Immunology • Psoriasis

SHR-1139-202: A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 in Patients With Moderate-to-severe Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=21 | Active, not recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

2026 AAD-Hengrui Pharmaceutical's world-first IL-23p19/IL-36R dual-target antibody SHR-1139 for patients with moderate-to-severe plaque psoriasis phase I study data released [Google translation] (Jiangsu Hengrui Press Release) - "At week 16, the clinically efficient treatment groups of SHR-1139 were higher than those in the placebo group. At week 16, the PASI 90 response rate in the SHR-1139 300 mg group and the SHR-1139 100 mg group was 83.3% and 66.7%, respectively, and the percentage change in PASI relative to the baseline was 98.5% and 96.6%, respectively. The clinical response continued until week 52. At week 52, the PASI 90 response rate was 100 percent and 66.7 percent, respectively, and the percentage change in PASI relative to baseline was -100.0 percent and-95.7 percent, respectively."

P1 data • Psoriasis

A Randomized, Double-blind, Dose-Escalation, Placebo-Controlled Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-1139 for Patients with Moderate-to-Severe Plaque Psoriasis (AAD 2026) - "SHR-1139 demonstrated good safety, tolerability, and long-lasting efficacy in psoriasis patients, potentially supporting once-per-year dosing in further studies."

Clinical • P1 data • PK/PD data • Dermatology • Dyslipidemia • Immunology • Infectious Disease • Plaque Psoriasis • Psoriasis

A Study to Evaluate SHR-1139 Injection in Patients With Pyoderma Gangrenosum (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P2 trial • Dermatology • Pyoderma Gangrenosum

A Trial of SHR-1139 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Atridia Pty Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis

SHR-1139-202: A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 in Patients With Moderate-to-severe Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Phase I Clinical Trial of Single Subcutaneous Injection or Intravenous Infusion of SHR-1139 Injection in Healthy Chinese Subjects and Multiple Subcutaneous Injections in Patients With Moderate-to-severe Plaque Psoriasis (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

A Clinical Study Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Ulcerative Pyoderma Gangrenosum (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: Shandong First Medical University

New P2 trial • Dermatology • Pyoderma Gangrenosum

A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 in Patients With Moderate-to-severe Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Trial of SHR-1139 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Atridia Pty Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

Jiangsu Hengrui Pharmaceuticals…announced that China’s National Medical Products Administration (NMPA) has granted approval for clinical trials of two independently developed biologics: SHR‑3045 injection for rheumatoid arthritis (RA) and SHR‑1139 injection for ulcerative colitis (UC) (flcube.com)

New trial • Rheumatoid Arthritis • Ulcerative Colitis

A Trial Comparing SHR-1139 Injection With Placebo in Patients With Moderate-to-severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=145 | Active, not recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis

A Trial of SHR-1139 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Atridia Pty Ltd.

New P1 trial • Dermatology • Immunology • Psoriasis

A Phase I Clinical Trial of Single Subcutaneous Injection or Intravenous Infusion of SHR-1139 Injection in Healthy Chinese Subjects and Multiple Subcutaneous Injections in Patients With Moderate-to-severe Plaque Psoriasis (clinicaltrials.gov) - P1 | N=64 | Active, not recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P1 trial • Dermatology • Immunology • Psoriasis