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

NCT ID: NCT07001839

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-12-31

Brief Summary

The goal of this open label, dose escalation phase 1b clinical trial is to investigate the safety, tolerability, pharmacokinetic, pharmacodynamics, immunogenicity and preliminary clinical efficacy of QLS4131 in subjects with systemic lupus erythematosus (SLE). The main questions it aims to answer are:

• The safety, tolerability and maximum tolerated dose (MTD) of QLS4131 for Injection in participants with SLE.
• The recommended Phase 2 dose (RP2D) of QLS4131 for Injection in participants with SLE.

Participants will be administered different target dose of QLS4131 for Injection only once. A step-up dosing approach will be implemented at high dose level as determined by the safety monitoring committee.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QLS4131

Target dose of each cohort will be administered only once

Group Type: EXPERIMENTAL

QLS4131 for Injection.

Intervention Type: DRUG

Eligible participants will be assigned to 1 of the 9 dose groups ranging from 0.06 μg/kg to 600 μg/kg.

Interventions

QLS4131 for Injection.

Eligible participants will be assigned to 1 of the 9 dose groups ranging from 0.06 μg/kg to 600 μg/kg.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Dandan Guo, PM

Role: CONTACT

dandan1.guo@qilu-pharma.com

13668889421

Other Identifiers

QLS4131-201

Identifier Type: -

Identifier Source: org_study_id