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A Multi-center, Randomized, Double-blind, Placebo Control Phase 1b/II Study to Evaluate the Safety and Efficacy of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of active SLE.
This is a phase Ib/II study, including 2 stage, phase Ib study to find the dose for phase II study between 0.8mg/kg、1.2mg/kg and 1.6mg/kg dose level, Phase II study is a multi-center, randomized, double-blind, placebo control study to evaluate the safety and efficacy of IMC-002 in active Systemic Lupus Erythematosus patients.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Start Date
October 10, 2024
Primary Completion Date
December 10, 2025
Completion Date
June 10, 2026
Last Updated
August 2, 2024
218
ESTIMATED participants
IMC-002 + SOC
DRUG
Placebo + SOC
DRUG
Lead Sponsor
ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
NCT06647069
NCT07371468
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06333483