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

Keymed Biosciences

Status and phase: Not yet enrolling; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Biological: CM313 injection; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06791772

CM313-106106

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males or females aged 18 to 65 years.
2. Voluntarily signed the informed consent form (ICF).
3. 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.
4. 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.
5. 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.
6. ≥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.
7. Maintain a stable standard treatment regimen for at least 30 days prior to initial dosing of the investigational product.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups, including a placebo group

Group A

Experimental group

Description:

CM313

Treatment:

Biological: CM313 injection

Biological: CM313 injection

Group B

Experimental group

Description:

CM313

Treatment:

Biological: CM313 injection

Biological: CM313 injection

Group C

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo