anflekitug (SSGJ-613) / 3SBio - LARVOL DELTA

Efficacy and safety of SSGJ-613 for acute gout flares in participants initiating urate-lowering therapy: a phase 2, randomized, open-label, multicenter, active-controlled trial (ACR Convergence 2026) - No abstract available

Clinical • P2 data • Gout • Inflammatory Arthritis • Rheumatology

SSGJ-613 for the treatment of acute gout flares: results from a randomized, double-blind, double-dummy, active-controlled phase 3 trial (ACR Convergence 2026) - No abstract available

Clinical • P3 data • Gout • Inflammatory Arthritis • Rheumatology

SSGJ-613 Alleviates Pain and Reduces the Risk of Acute Flares in Patients With Gout: A Randomized, Double-Blind, Phase II Study. (PubMed, Int J Rheum Dis) - P3 | "A single injection of SSGJ-613 demonstrated rapid pain relief comparable to corticosteroid therapy at 72 h and provided superior protection against gout flare recurrence over 12 weeks in Chinese patients, supporting its potential as an effective treatment option for acute gouty arthritis with prolonged therapeutic benefits."

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

A Study of SSGJ-613 in Gout Participants Initiating Urate-Lowering Treatment (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

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

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