A Phase Ib Study of QLS4131 in Subjects With Systemic Lupus Erythematosus

Launched by QILU PHARMACEUTICAL CO., LTD. · May 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called QLS4131 for people with Systemic Lupus Erythematosus (SLE), a condition where the immune system mistakenly attacks the body. The main goals are to see how safe this treatment is, how well it is tolerated, and to find the right dose that works best for patients. Participants will receive a single injection of QLS4131, and the study will gradually increase the dose to find the maximum amount that can be given safely.

To be eligible for this trial, participants must be between 18 and 70 years old and have been diagnosed with SLE for at least 12 weeks. They should also have specific antibodies in their blood that indicate active lupus disease. Those who are currently taking certain standard treatments for lupus may participate, as long as their doses have been stable for a month. It's important to note that this trial is not recruiting yet, and participants will need to understand the study procedures and agree to take part by signing a consent form.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18 to 70 (inclusive);
• • Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (ACR) Classification Criteria at least 12 weeks or more prior to screening;
• • Participants with positive antinuclear antibody (ANA) (≥ 1:80), or positive anti-dsDNA antibody and/or positive anti-Sm antibody at screening;
• • Active SLE disease at screening, as demonstrated by a SLEDAI-2K \>= 8 at screening, or SLEDAI-2K \>= 6 at the presence of low complement and/or positive anti-dsDNA antibodies;
• * Current receipt of one or more of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroids, antimalarial agents, and conventional immunosuppressants:
• • 1. For participants receiving an oral corticosteroid, treatment with ≤40 mg/day prednisone or equivalent, at a dose that has been stable for at least 4 weeks prior to first dose;
• • 2. For participants receiving an antimalarial, the medication(s) must have been at a stable dose ≥ 4 weeks prior to the first dose;
• • 3. For participants receiving immunosuppressants, treatment with a single immunosuppressant at a stable dose for ≥ 4 weeks prior to the first dose: conventional immunosuppressants include azathioprine, mycophenolate mofetil, mycophenolic acid, and methotrexate (oral, subcutaneous or intravenous routes).
• • Participants who understand and abide by the study procedures, voluntarily participate in this study, and sign the Informed Consent Form in person.
• Exclusion Criteria:
• • Participants with known intolerance or allergy to the investigational product or drugs that may be used in the study (e.g., Tocilizumab) and any components;
• • Participants with active severe active or unstable lupus-associated neuropsychiatric disease;
• • Participants with other autoimmune diseases that may affect the efficacy evaluation;
• • Participants with poorly controlled hypertension and diabetes;
• • Participants with severe lupus nephritis;
• • Participants with a history of malignancy within 5 years prior to screening;
• • Participants with a previous history of vital organ transplantation;
• • Participants who have had opportunistic infections within 12 weeks prior to the first dose;
• • Receipt of any CAR-T, CAR-NK or other gene therapy;
• • Pregnant or lactating women.