To Evaluate the Efficacy and Safety of SG301 SC Injection in Systemic Lupus Erythematosus

NCT07447986 | Recruiting Phase 2

• 1 other identifier: CSG-301 SC-205
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This was a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study. The primary objective was to evaluate the efficacy of SG301 SC injection in participants with Systemic Lupus Erythematosus (SLE) based on the Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response rate. The secondary objectives were to assess the safety, pharmacokinetics, pharmacodynamics, and immunogenicity profiles of SG301 SC injection in these participants .

Conditions

Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4)

  SRI-4 response is defined as: * Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of ≥ 4 points; * No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline; * No worsening in Physician's Global Assessment (PGA), defined as an increase of ≥ 0.3 from baseline;

  From baseline to week 25

Study Arms (3)

SG301 SC - A

EXPERIMENTAL

SG301 SC Injection

Drug: SG301 SC Injection

SG301 SC -B

EXPERIMENTAL

SG301 SC Injection

Drug: SG301 SC Injection

Placebo

PLACEBO COMPARATOR

SG301 SC Placebo

Drug: SG301 SC placebo

Interventions

SG301 SC Injection DRUG

One injection per week for 8 doses, followed by one injection every two weeks for another 8 doses, with a total of 16 injections administered.

SG301 SC - A

SG301 SC placebo DRUG

One injection per week for 8 doses, followed by one injection every two weeks for another 8 doses, with a total of 16 injections administered.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in the clinical study and sign a written informed consent form.
• Participants must be diagnosed with SLE in accordance with the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatism (ACR) SLE classification criteria and have inadequate response to standard treatment, intolerance to standard treatment, or recurrent disease.
• SLEDAI-2K score ≥ 8 points, with clinical features corresponding to a SLEDAI-2K score ≥ 4 points.
• Positive serological test results for autoantibodies, defined as antinuclear antibody (ANA) positivity and/or anti-double-stranded DNA (anti-dsDNA) antibody positivity.
• Body weight ≥ 35 kg.
• Must have received standard treatment for at least 8 weeks before the first dose and maintained a stable dose of the treatment unchanged for at least 4 weeks before the first dose.
• Participants of childbearing potential or whose partners are of childbearing potential must agree to use effective contraceptive measures throughout the entire study period and within 6 months after the last dose.

You may not qualify if:

• Previous use of CD38 or monoclonal antibodies targeting CD38.
• Active central nervous system (CNS) disease within 2 months before the first dose, or CNS disease that the investigator believes may require treatment with prohibited therapies specified in the protocol.
• Diagnosis of mixed connective tissue disease or a history of any overlap syndrome between SLE and systemic sclerosis.
• Laboratory abnormalities.
• Current acute or chronic infection meeting any of the following criteria.
• Participation in any other clinical trial within 4 weeks before the first dose (excluding participants who provided informed consent but did not receive trial treatment, or only received placebo).
• Use of any targeted T or B lymphocyte drugs (e.g., rituximab) within 3 months before the first dose.
• Receipt of any B cell-depleting drugs (such as belimumab, telitacicept) within 4 weeks or 5 half-lives (whichever is shorter) before the first dose.
• Receipt of JAK inhibitor treatment within 2 weeks before the first dose.
• Presence of severe cardiovascular and cerebrovascular diseases.
• Mycobacterium tuberculosis infection.
• Presence of HIV infection, active hepatitis B, or hepatitis C.
• Known history of active syphilis.
• History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/or bone marrow transplantation.
• Other conditions that the investigator believes would prevent the participant from participating in the study.

Sponsors & Collaborators

• Hangzhou Sumgen Biotech Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Yue Song

CONTACT

+86-18511021346; songyue@sumgenbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 4, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)