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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-24

Study Completion Date

2028-11-04

Brief Summary

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

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Detailed Description

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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.

Conditions

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Systemic Lupus Erythematosus (SLE)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Intervention Type DRUG

626 subcutaneous (SC) injection.

Interventions

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626

626 subcutaneous (SC) injection. Placebo subcutaneous (SC) injection.

Intervention Type DRUG

626

626 subcutaneous (SC) injection.

Intervention Type DRUG

Placebo

Placebo subcutaneous (SC) injection.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No