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

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

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

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus (SLE)
• Intervention / Treatment: Drug: Placebo; Drug: 626; Drug: 626

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 Type: Interventional
• Enrollment (Estimated): 198
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Qinghong Zhou; Phone Number: +86 18911301578; Email: zhouqinghong@3sbio.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Mengtao Li; Phone Number: +86 13911788572; Email: Mengtao.li@cstar.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo subcutaneous (SC) injection.	Drug: Placebo; Placebo subcutaneous (SC) injection.
Experimental: Group M1; dose level 1 of 626	Drug: Placebo; Placebo subcutaneous (SC) injection.; Drug: 626; 626 subcutaneous (SC) injection. Placebo subcutaneous (SC) injection.; Drug: 626; 626 subcutaneous (SC) injection.
Experimental: Group M2; dose level 2 of 626	Drug: Placebo; Placebo subcutaneous (SC) injection.; Drug: 626; 626 subcutaneous (SC) injection. Placebo subcutaneous (SC) injection.; Drug: 626; 626 subcutaneous (SC) injection.
Experimental: Group M3; dose level 3 of 626	Drug: Placebo; Placebo subcutaneous (SC) injection.; Drug: 626; 626 subcutaneous (SC) injection. Placebo subcutaneous (SC) injection.; Drug: 626; 626 subcutaneous (SC) injection.
Experimental: Group M4; dose level 4 of 626	Drug: Placebo; Placebo subcutaneous (SC) injection.; Drug: 626; 626 subcutaneous (SC) injection. Placebo subcutaneous (SC) injection.; Drug: 626; 626 subcutaneous (SC) injection.
Experimental: 626 Dose A; 626 Dose A subcutaneous (SC) injection.	Drug: 626; 626 subcutaneous (SC) injection. Placebo subcutaneous (SC) injection.; Drug: 626; 626 subcutaneous (SC) injection.
Experimental: 626 Dose B; 626 Dose B subcutaneous (SC) injection	Drug: 626; 626 subcutaneous (SC) injection. Placebo subcutaneous (SC) injection.; Drug: 626; 626 subcutaneous (SC) injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Adverse Events	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.	During the 32- or 36-week study period

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Peak Plasma Concentration (Cmax)	During the 32- or 36-week study period
Area under the Concentration-Time Curve up to the Last Measurable Concentration（AUC0-last）	During the 32- or 36-week study period
Time to Peak Concentration（Tmax ）	During the 32- or 36-week study period

Collaborators and Investigators

• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2025
• Primary Completion (Estimated): August 12, 2028
• Study Completion (Estimated): November 4, 2028

Study Registration Dates

• First Submitted: September 9, 2025
• First Submitted That Met QC Criteria: September 18, 2025
• First Posted (Estimated): September 22, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: SSGJ-626-SLE-Ib/II-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No