Tests SCTB35 in adults with systemic lupus erythematosus

Trial details

Who runs it

Sinocelltech Ltd.

Trial code

NCT06841042

Record updated

21 February 2025

Original description

This study is a multicenter Phase Ib/II clinical trial aimed at evaluating the safety, tolerability and efficacy of SCTB35 in patients with systemic lupus erythematosus (SLE).Read full original descriptionShow less

A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SCTB35 in Patients with Systemic Lupus Erythematosus

This study is a multicenter Phase Ib/II clinical trial aimed at evaluating the safety, tolerability and efficacy of SCTB35 in patients with systemic lupus erythematosus (SLE).

Inclusion: Age 18-75 years；; Diagnosed with SLE for ≥12 weeks prior to screening (2019-ACR/EULAR criteria); SLEDAI-2K ≥ 8 at screening, or ≥6 if there is hypocomplementemia or elevated anti-dsDNA antibody levels; Positive for ANA (1:80) or positive for anti-dsDNA and/or anti-Sm antibodies within the last 12 months or at screening; Currently receiving ≥1 stable dose of standard treatment: oral corticosteroids, antimalarials, or conventional immunosuppressive drugs; Stable corticosteroid dose for ≥4 weeks prior to baseline; Stable dose of antimalarial drugs for ≥4 weeks prior to baseline; Stable dose of immunosuppressive agents for ≥4 weeks prior to baseline; All male participants or females of reproductive potential must agree to use reliable contraception with their partner from signing the ICF through 6 months after the last dose of the study drug; Understanding of the study procedures and voluntary signing of the informed consent form.

Exclusion: Received treatments that may affect the drug's effect:; Received live vaccines or attenuated vaccines within 28 days prior to baseline or screening; Received any investigational treatment within 30 days prior to baseline or within 5 half-lives of the investigational drug (whichever is longer); Alcohol abuse or drug misuse within 12 months prior to screening; Required hospitalization for major surgery within 4 weeks prior to screening or within 12 weeks post-study drug administration; Severe active or unstable lupus-related neuropsychiatric disorders; Other autoimmune diseases that may interfere with efficacy evaluation; Catastrophic antiphospholipid syndrome; Clinically significant bleeding risk; Participants with recurrent, chronic, or other active infections as assessed by the investigator; Severe or uncontrolled disease, which would prevent participation in the study; Positive viral serology tests, including HIV, HCV, and HBV; Tuberculosis screening: Known active tuberculosis or latent tuberculosis infection (LTBI); Any type of active infection except nail bed fungal infections; Severe infections; History of progressive multifocal leukoencephalopathy (PML); Diagnosed with type 1 or type 2 diabetes with poor control; Uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg); History of malignancy within 5 years prior to baseline; Intolerance to the study drug or contraindications, including a history of severe allergic reactions to monoclonal antibodies or any component of SCTB35 injection; Participants with mental disorders or poor compliance; History of solid organ or hematopoietic stem cell/bone marrow transplant, or expected to undergo transplant surgery during the study; Any other condition that the investigator deems unsuitable for participation in the study; Abnormal laboratory results:; AST or ALT >2.5 x ULN; Total bilirubin >1.5 x ULN; ANC <1.5x10⁹/L; Platelets <75x10⁹/L; Hemoglobin <100g/L; eGFR <30 mL/min/1.73 m²; Positive serum HCG; Severe lupus nephritis; Pregnant or breastfeeding.

ClinicalTrials.gov NCT06841042