The Purpose of This Study is to Evaluate the Efficacy and Safety of 626 in the Treatment of SLE

Not Applicable

Not yet recruiting

• Conditions: Systemic Lupus Erythematosus (SLE)
• Interventions: Drug: 626; Drug: Placebo

• Registration Number: NCT07185269
• Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Brief Summary

This study will evaluate the effect and safety of 626 in patients with SLE

Detailed Description

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease with heterogeneous manifestations and disease course. Despite advances in medical care, there are still significant unmet needs in SLE with persistent disease activity, disease flares, intolerance to standard of care (SOC) therapies, and development of organ damage and co-morbidities.

The purpose of this study is to demonstrate the clinical efficacy and safety of 626 added to standard of care (SoC) therapy compared to placebo with SoC therapy in subjects with SLE.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-09
• Study Start: 2025-09-11
• Study First Submitted QC: 2025-09-18
• Last Update Submitted: 2025-09-18
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Primary Completion: 2028-08-12
• Study Completion: 2028-11-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• Able to understand protocol requirements and sign a written ICF.

• Male or female subjects aged 18-70 years when signing the ICF.

• Body weight between 40 and 90 kg.

• Diagnosed with SLE at least 6 months before the Screening Visit by a qualified physician，confirmed according to the 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE.

• At screening, meet at least one of the following criteria:

  1. Anti-nuclear antibody (ANA) titer ≥ 1:80;
  2. Positive anti-dsDNA antibody..

• Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 with clinical SLEDAI score ≥4 points at Screening and Baseline Visit .

• Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.

Exclusion Criteria

• Study participant has a mixed connective tissue disease, and/or overlap syndrome of systemic lupus erythematosus (SLE) with systemic sclerosis.
• Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition
• Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
• History of cancer.
• Active severe lupus nephritis present within 2 months prior to baseline. Or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2, or protein:creatinine ratio >2.0 g/g.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group M1	626	dose level 1 of 626
Group M1	Placebo	dose level 1 of 626
Group M2	626	dose level 2 of 626
Group M2	Placebo	dose level 2 of 626
Group M3	626	dose level 3 of 626
Group M3	Placebo	dose level 3 of 626
Group M4	626	dose level 4 of 626
Group M4	Placebo	dose level 4 of 626
626 Dose A	626	626 Dose A subcutaneous (SC) injection.
626 Dose B	626	626 Dose B subcutaneous (SC) injection
Placebo	Placebo	Placebo subcutaneous (SC) injection.

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events	During the 32- or 36-week study period	Incidence of adverse events will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments.

Secondary Outcome Measures

Name	Time	Method
SLE Responder Index (SRI-4)	During the 20- or 24-week treatment period	Proportion of subjects achieving an SLE Responder Index (SRI-4) response
BILAG-based Combined Lupus Assessment (BICLA) Response	During the 20- or 24-week treatment period	Proportion of patients achieving a BILAG-based Combined Lupus Assessment (BICLA) response

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing Municipality, China