SSGJ-613 / 3SBio - LARVOL DELTA

A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment. (clinicaltrials.gov) - P2 | N=157 | Active, not recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2024 ➔ Oct 2024

Enrollment closed • Trial primary completion date • Gout • Immunology • Inflammatory Arthritis • Rheumatology

SSGJ-613 RELIEVES PAIN AND REDUCES THE RISK OF ACUTE FLARES IN PATIENTS WITH GOUT: RESULTS OF A RANDOMIZED, DOUBLE-BLIND, PHASE II STUDY (EULAR 2024) - "These results demonstrated that a single injection of SSGJ-613 could achieve rapid pain relief similar to that of steroids in Chinese patients with gout and provide effective prophylaxis against flares. To confirm the efficacy and safety of SSGJ-613 in Chinese gout patients, further trials will be initiated soon."

Clinical • P2 data • Gout • Immunology • Inflammatory Arthritis • Pain • Rheumatology • CRP • IL1B

A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment. (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Gout • Immunology • Inflammatory Arthritis • Rheumatology

A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment. (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P2 trial • Gout • Immunology • Inflammatory Arthritis • Rheumatology

A Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P3 trial • Gout • Inflammatory Arthritis • Rheumatology

The MAD Study of SSGJ-613 in Healthy Subjects (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatology

A Phase Ib/II Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout (clinicaltrials.gov) - P1/2 | N=120 | Recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P1/2 trial • Gout • Inflammatory Arthritis • Rheumatology

New crown antigen detection ushered in the liberalization of many science and technology innovation board companies to respond to related business situations [Google translation] (Sina Corp) - "Sunshine Guojian announced that..the company's recombinant anti-IL-1β humanized monoclonal antibody injection (R&D code: SSGJ-613) received the approval issued by the State Food and Drug Administration for the clinical trial of acute gouty arthritis 'Drug Clinical Trials'. Approval Notice', SSGJ-613 has completed the enrollment of all subjects in the Phase Ia clinical trial, and will conduct a Phase Ib/II clinical trial for acute gouty arthritis indications in the near future."

Enrollment closed • New P1/2 trial • Idiopathic Arthritis • Immunology

Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection (clinicaltrials.gov) - P1; N=34; Recruiting; Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Clinical • New P1 trial • Idiopathic Arthritis • Immunology • Rheumatology • IL1B