Tests GNC-038 injection against placebo in rheumatoid arthritis

Trial details

Who runs it

Sichuan Baili Pharmaceutical Co., Ltd.

Trial code

NCT06857227

Record updated

15 April 2025

Original description

This study is a randomized controlled phase I clinical study with safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics in patients with rheumatoid arthritis.Read full original descriptionShow less

A Randomized Controlled Phase l Clinical Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of GNC-038 Tetra-specific Antibody Injection in Rheumatoid Arthritis

This study is a randomized controlled phase I clinical study with safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics in patients with rheumatoid arthritis.

Inclusion: Subjects can understand the informed consent form, voluntarily participate in and sign the informed consent form; No gender limit; Age: ≥18 years old and ≤75 years old; Life expectancy greater than 6 months; Patients diagnosed with rheumatoid arthritis according to 1987 or 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria; Patients were moderately to severely active RA at the time of screening; A stable standard-of-care regimen was maintained for at least 30 days before the first dose; Previous treatment with antirheumatic drugs other than MTX: Leflunomide should be discontinued at least 8 weeks before the start of study treatment or cholestyramine should be used for 14 days; Erythrocyte sedimentation rate (ESR) > 28mm/hr or C-reactive protein (CRP) > 10mg/L; Positive rheumatoid factor and/or anti-cyclic citrullinated peptide antibodies; There were CD19+ B cells in the peripheral blood of the patient; Diagnosis of rheumatoid arthritis (RA) more than 6 months; The organ function level before the first administration met the requirements; Fertile female subjects or male subjects with fertile partners must use highly effective contraception from 7 days before the first dose until 24 weeks after the termination of treatment and should commit not to donate eggs (eggs, oocytes)/sperm for assisted reproduction for 1 year after the last study treatment. Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose; Participants were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.

Exclusion: B cell-targeted therapy agents administered within 6 months before GNC-038 treatment; Received CAR-T therapy within 6 months before GNC-038 treatment; Use of anti-TNF drugs within 8 weeks before administration; Use of any JAK inhibitor within 2 weeks before dosing; Antimalarial drugs, sulfasalazine, penicillamine, etc. were used within 4 weeks before the drug administration; Use of phytochemicals within 4 weeks before administration; The use of other biological agents or other non-B cell depleting clinical investigational drugs before drug administration did not exceed 5 half-lives; Received an intra-articular injection within 4 weeks before study entry; Receipt of any investigational drug within 28 days before dose or within 5 half-lives of the investigational drug; A history of any cardiovascular disease described in the protocol within 6 months before screening; A history of ≥ grade 2 bleeding within 30 days before screening or the need for long-term continuous anticoagulant therapy; Having a history or evidence of suicidal thoughts within 6 months before signing ICF, which is considered by the researcher to be a significant risk of suicide; Investigators considered a history of alcohol or drug abuse in the 12 months before screening; Any active infection requiring systemic antibiotic treatment within 2 weeks before or during screening; Confirmed diagnosis of another autoimmune rheumatic disease; History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation; Presence of: 1) active hepatitis B at screening; 2) hepatitis C or HIV infection; 3) syphilis infection; Poorly controlled hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg); Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of GNC-038; Diagnosed with malignant tumor within 5 years before signing ICF; History of splenectomy; A history of severe and/or disseminated viral infection; Active M. tuberculosis infection may be present; Prolonged QT interval at rest (QTcf > 450 msec in men or > 470 msec in women); ACR functional class IV or bedridden/wheelchair-bound; Women who are pregnant or breastfeeding; Other situations of poor compliance, unwillingness or inability to comply with the study protocol as judged by the investigator.

ClinicalTrials.gov NCT06857227