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Recruiting NCT07185269

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

Phase I / Phase II Interventional Systemic Lupus Erythematosus (SLE)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 626, 626, Placebo.
Who it may be relevant to
Registry conditions: Systemic Lupus Erythematosus (SLE). Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ib/II Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Immunogenicity of Anti-BDCA2 Antibody SSGJ-626 in Subjects With Systemic Lupus Erythematosus

Overview

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.

Interventions

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

Primary outcome measures

  • Number of participants with Adverse Events [Time frame: During the 32- or 36-week study period]
Secondary outcome measures (2)
  • SLE Responder Index (SRI-4) [Time frame: During the 20- or 24-week treatment period]
  • BILAG-based Combined Lupus Assessment (BICLA) Response [Time frame: During the 20- or 24-week treatment period]

Eligibility criteria

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:
  • Anti-nuclear antibody (ANA) titer ≥ 1:80;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT07185269 · SSGJ-626-SLE-Ib/II-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗