A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus
NCT ID: NCT05465707
Last Updated: 2022-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2022-10-30
2023-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of CM313(SC) Injection in Systemic Lupus Erythematosus(SLE)
NCT06791772
A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus
NCT02411136
A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus
NCT01702740
A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus
NCT01127321
A Phase Ib Study of QLS4131 in Subjects With Systemic Lupus Erythematosus
NCT07001839
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
About 40 patients who meet eligibility criteria will be randomized 4:1 to receive either CM313 or matched placebo, intravenous infusion.
The treatment period includes single dosing and multiple dosing period, in which CM313 and placebo will be adminitrated intravenously, once every 1 week.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CM313 2 mg/kg
Once 1 week, intravenous infusion.
CM313 2 mg/kg
Once 1 week, intravenous infusion.
CM313 4 mg/kg
Once 1 week, intravenous infusion.
CM313 4 mg/kg
Once 1 week, intravenous infusion.
CM313 8 mg/kg
Once 1 week, intravenous infusion.
CM313 8 mg/kg
Once 1 week, intravenous infusion.
CM313 16 mg/kg
Once 1 week, intravenous infusion.
CM313 16 mg/kg
Once 1 week, intravenous infusion.
Placebo
Once 1 week, intravenous infusion.
Placebo
Once 1 week, intravenous infusion.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CM313 2 mg/kg
Once 1 week, intravenous infusion.
CM313 4 mg/kg
Once 1 week, intravenous infusion.
CM313 8 mg/kg
Once 1 week, intravenous infusion.
CM313 16 mg/kg
Once 1 week, intravenous infusion.
Placebo
Once 1 week, intravenous infusion.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Positive autoantibody serology test at screening.
* Contraception.
* Voluntarily sign the ICF.
Exclusion Criteria
* Possibly active Mycobacterium tuberculosis infection.
* With the history of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation.
* Heavy drinking in the 3 months prior to screening.
* With depression or suicidal thoughts.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Keymed Biosciences Co.Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CM313-106001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.