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Trial intelligence / Profile preview
CM313 in Subjects With Systemic Lupus Erythematosus
NCT05465707Phase 2
Key facts
- Status
- Unknown
- Start
- Oct 2022
- Primary completion
- Oct 2023
- Sponsor
- Keymed Biosciences
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- cm313
- Conditions
- systemic lupus erythematosus (SLE)
01
Overview
Phase 2, randomised, double-blind trial of cm313 in systemic lupus erythematosus (SLE) (5 arms), sponsored by Keymed Biosciences. Primary endpoint: Incidence of treatment-emergent adverse events. Status: unknown.
02
Design
5 arms- Study design
- RandomizedDouble-blind
CM313 2 mg/kg
CM313 2 mg/kg IV infusion
CM313 4 mg/kg
CM313 4 mg/kg IV infusion
CM313 8 mg/kg
CM313 8 mg/kg IV infusion
CM313 16 mg/kg
CM313 16 mg/kg IV infusion
Placebo
Matched placebo IV infusion
03
Who it enrols
Adult patients (18-65) with Systemic Lupus Erythematosus and positive autoantibodies, excluding those with recent CNS disease, active TB, or prior organ/stem cell transplants.
04
Endpoints
Primary
Incidence of treatment-emergent adverse events
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