Iremod (iguratimod) / Simcere - LARVOL DELTA

The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome (clinicaltrials.gov) - P4 | N=78 | Recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University | Trial completion date: Jul 2023 ➔ Jul 2025 | Trial primary completion date: Dec 2022 ➔ Dec 2024

Trial completion date • Trial primary completion date • Immunology • Sjogren's Syndrome

Iguratimod suppresses plasma cell differentiation and ameliorates experimental Sjögren's syndrome in mice by promoting TEC kinase degradation. (PubMed, Acta Pharmacol Sin) - "After immunization, ESS mice were orally treated with iguratimod (10, 30, 100 mg·kg-1·d-1) or hydroxychloroquine (50 mg·kg-1·d-1) for 70 days. Together, we demonstrate that iguratimod effectively ameliorates ESS via its unique suppression of TEC function, which will be helpful for its clinical application. Targeting TEC kinase, a new regulatory factor for B cells, may be a promising therapeutic option."

Journal • Preclinical • Immunology • Sjogren's Syndrome • Targeted Protein Degradation

Efficacy, safety, and recurrence of Iguratimod combined with csDMARDs treatment in rheumatoid arthritis: A prospective real-world study (EULAR 2023) - P4 | "Conclusion The RA patients could achieve deeper REM and sustained after long-term treatment of IGU combination with csDMARDs. LDA or REM should be achieved before reducing the dose of IGU and csDMARDs, especially for the long-course, younger, with shorter morning stiffness RA patients."

Clinical • Real-world • Real-world evidence • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Iguratimod Combined With Tofacitinib in the Treatment of Rheumatoid Arthritis (clinicaltrials.gov) - P4 | N=138 | Not yet recruiting | Sponsor: Nanfang Hospital of Southern Medical University

New P4 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome (clinicaltrials.gov) - P4 | N=78 | Recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting ➔ Recruiting | Initiation date: Jul 2021 ➔ Jan 2022

Enrollment open • Trial initiation date • Sjogren's Syndrome

The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Peking University People's Hospital

New P2 trial • Hematological Disorders • Thrombocytopenia • Thrombocytopenic Purpura

The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome (clinicaltrials.gov) - P4; N=78; Not yet recruiting; Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P4 trial • Sjogren's Syndrome

Iguratimod promotes transformation of mononuclear macrophages in elderly patients with rheumatoid arthritis by nuclear factor-κB pathway. (PubMed, World J Clin Cases) - "Iguratimod can promote the transformation of mononuclear macrophages from M1 to M2 in elderly patients with RA by inhibiting the nuclear factor-κB pathway, thus improving symptoms of RA."

Clinical • Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CD163 • IL1B • IL4 • IL6 • MRC1

A Study to Evaluate the Efficacy and Safety of Iguratimod Compared to Placebo in Patients With Active Primary Sjogren's Syndrome. (clinicaltrials.gov) - P2; N=144; Recruiting; Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

New P2 trial • Complement-mediated Rare Disorders • Immunology • Sjogren's Syndrome

Safety and efficacy of combination therapy of iguratimod with methotrexate for patients with active rheumatoid arthritis with an inadequate response to methotrexate: an open-label extension of a randomized, double-blind, placebo-controlled trial. (PubMed) - "No deaths occurred. Efficacy and tolerance of iguratimod + MTX therapy was maintained to 52 weeks in patients with active RA with inadequate response to MTX."

Journal • Biosimilar • Immunology • Inflammation • Rheumatoid Arthritis

Iguratimod in Kidney Transplant Recepients (clinicaltrials.gov) - P=N/A; N=60; Recruiting; Sponsor: The First Affiliated Hospital with Nanjing Medical University; Not yet recruiting ➔ Recruiting

Enrollment open • Biosimilar • Immunology

Efficacy and safety evaluation of a combination of iguratimod and methotrexate therapy for active rheumatoid arthritis patients: a randomized controlled trial. (PubMed) - "There was no significant increase in adverse events in the MTX + T-614 group comparing with the MTX group (P > 0.05). The combination of MTX and T-614 therapy appeared to have a good efficacy and safety for active RA and was superior to MTX-alone therapy after 24 weeks of treatment."

Journal • Biosimilar • Immunology • Inflammation • Pain • Rheumatoid Arthritis

The combined effects of iguratimod, a novel DMARD, and methotrexate on adjuvant-induced arthritis and collagen-induced arthritis (EULAR 2012) - Anticipated preclinical publication at EULAR 2012

Anticipated data publication • Immunology • Rheumatoid Arthritis

Iguratimod as Treatment for Active Lupus Nephritis (clinicaltrials.gov) - P2; N=120; Not yet recruiting; Sponsor: RenJi Hospital

New P2 trial • Biosimilar • Complement-mediated Rare Disorders • Lupus

A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - P3; N=200; Not yet recruiting; Sponsor: ImmuPharma

New P3 trial • Biosimilar • Lupus

A study of iguratimod in patients with active rheumatoid arthritis (clinicaltrials.gov) - P4, N=2,400; Not yet recruiting; New P4 trial

New trial • Immunology • Rheumatoid Arthritis