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

Sunshine Guojian Pharmaceutical

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Systemic Lupus Erythematosus (SLE)

Treatments: Drug: Placebo; Drug: 626

Study type: Interventional

Funder types: Industry

Identifiers

NCT07185269

SSGJ-626-SLE-Ib/II-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 198 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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198 participants in 7 patient groups, including a placebo group

Group M1

Experimental group

Description:

dose level 1 of 626

Treatment:

Drug: 626

Drug: 626

Drug: Placebo

Group M2

Experimental group

Description:

dose level 2 of 626

Treatment:

Drug: 626

Drug: 626

Drug: Placebo

Group M3

Experimental group

Description:

dose level 3 of 626

Treatment:

Drug: 626

Drug: 626

Drug: Placebo

Group M4

Experimental group

Description:

dose level 4 of 626

Treatment:

Drug: 626

Drug: 626

Drug: Placebo

626 Dose A

Experimental group

Description:

626 Dose A subcutaneous (SC) injection.

Treatment:

Drug: 626

Drug: 626

626 Dose B

Experimental group

Description:

626 Dose B subcutaneous (SC) injection

Treatment:

Drug: 626

Drug: 626

Placebo

Placebo Comparator group

Description:

Placebo subcutaneous (SC) injection.

Treatment:

Drug: Placebo