Study of CM313(SC) Injection in Systemic Lupus Erythematosus(SLE)

NCT06791772 | Not Yet Recruiting Phase 2

• 1 other identifier: CM313-106106
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of CM313(SC) injection in systemic lupus erythematosus(SLE)

Conditions

Systemic Lupus Erythematosus

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

  Up to week 24

Study Arms (3)

Group A

EXPERIMENTAL

CM313

Biological: CM313 injection

Group B

EXPERIMENTAL

CM313

Biological: CM313 injection

Group C

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

CM313 injection BIOLOGICAL

CM313 600mg（4ml）/vial. Subcutaneous injection 600mg. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses.

Group A

Placebo DRUG

Placebo 4 mL/vial. Subcutaneous injection 4 or 8 mL. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses.

Group C

Eligibility Criteria

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

You may qualify if:

• Males or females aged 18 to 65 years.
• Voluntarily signed the informed consent form (ICF).
• Patients were diagnosed with systemic lupus erythematosus(SLE) according to the diagnostic classification criteria of the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) in 2019.
• Systemic Lupus Erythematosus Disease Activity Index - 2000(SLEDAI-2K) score ≥6 during screening, and SLEDAI-2K clinical score (except for low complement and/or positive anti-dsDNA antibodies) ≥4 during screening and at baseline.
• Positive antinuclear antibody and/or anti-dsDNA antibody results defined in accordance with the laboratory reference value range of the Central laboratory during the screening.
• ≥1British Isles Lupus Assessment Group-2004 (BILAG-2004) organ system rated as A or ≥ 2 organ system rated as B, and Physician's Global Assessment(PGA) score ≥1.0 during screening.
• Maintain a stable standard treatment regimen for at least 30 days prior to initial dosing of the investigational product.

You may not qualify if:

• Kidney disease: Severe lupus nephritis within within 8 weeks prior to randomization.
• Patients with systemic lupus erythematosus(SLE) or non-SLE related central nervous system disease within 8 weeks prior to randomization.
• There were non-SLE inflammatory skin or joint diseases that the investigators thought might be evaluated during the screening period.
• History of clinically significant diseases.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

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

Study Officials

• Xiaofeng Zeng

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Jia

CONTACT

028-88610620; qianjia@keymedbio.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: January 19, 2025
• First Posted: January 24, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

CN (1)